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Sr.Executive- Quality Assurance In Pharma Company Resume
Name:
Supriya
Location:
India-Maharashtra-Aurangabad
Experience:
Willing to Relocate:
Willing to Travel:
Most Recent Job Title:
Sr.Executive- Quality Assurance in Pharma company
Personal Website:
Objective:
Seeking middle level assignments in Regulatory Affaires/ Quality Assurance/ Quality Control with a reputed organization in the Pharmaceutical Sector.
Resume Text:
SUPRIYA PRAVIN PATIL
CONTACT DETAILS: Number Hidden/ Number Hidden; e Mail: Address Hidden
Objective: Seeking middle level assignments in Regulatory Affaires/ Quality Assurance/ Quality Control with a reputed organization in the Pharmaceutical Sector.
Strengths: With over 6.5 years of experience in Quality Control, Stability Study and Compliance Management have the deftness in handling stability study documents, quality system documents, regulatory documents, cGMP documents. Proven abilities in effectuating for preparedness of facing any time regulated audits. Effective communicator with excellent relationship management skills and possess a result oriented attitude with analytical skills. Currently serving as Sr.Executive – Quality Assurance with Siddharth Carbochem Products Ltd., Jalgaon.
Academic Profile: First Class Post Graduate in Biochemistry from Mooljee Jaitha College, Jalgaon affiliated to North Maharashtra University, Jalgaon (Maharashtra)-2004.
Additional Qualification:-
FDA approved for Chemical and Instrumental Analysis (subjected to Aurangabad jurisdiction).
Extra- Curricular Activities:-
1) Carried out project work on, “Surveillance of Diabetic Patients in Jalgaon City”, as a partial fulfillment for M.Sc. programme.
2) Conducted Seminar on, “Cryopreservation Techniques and its Applications”, as a partial fulfillment of M.Sc. programme.
3) Passed MS-CIT examination with 77% marks.
4) Passed ‘C’- Programming with ‘A’ grade.
Employment Scan:-
I) Sep-2010- till date Siddharth Carbochem Products Ltd., Jalgaon, Sr.Executive- QA
The company is diversified in manufacturing quality range of Bulk Drugs which include APIs like Aspirin, Methyl Salicylate, Amyl Salicylate, and Salicylic Acid.
The company is certified by ISO 9001: 2008 QMS, ISO 14001: 2004 EMS, ISO 18001: 2007 OHSAS, KOSHER and NSF.
Job Profile:
Reviewing of analytical data of QC, Production, R & D and Stores. Preparation of CAPA reports, Handling of OOS and Deviations and preparing the investigation reports of
the same. Responsible for GMP, GLP and Safety related documents. Preparation of Specifications, STPs & SOPs. Conducting Internal audits for compliance in House-Keeping, Safety and on-line documentation.
II) Feb-2010- Aug-2010 Wockhardt Biotech Park LTD, Aurangabad, Executive- QC
A professionally managed fast growing Pharmaceutical Company having its manufacturing facilities at different locations in Aurangabad and rest of India, it sets up a 100% Export oriented Insulin & Erythropoietin API, Sterile and Formulation facility in Aurangabad to meet the requirement of its customers in USA, Russia, Columbia and other European markets. The company is certified with US-FDA, MHRA, TFDA, Colombia INVIMA & WHO-GMP. Also the company has its well equipped and modern R&D center in Aurangabad.
Job Profile:
Analysis as well as documentation of API Bulk, Inprocess samples and Stability Products. Preparation, analysis as well as documentation of Working Standards. Reviewing of analytical data. Preparation of CAPA reports, Handling of OOS and Deviations and preparing the investigation reports of
the same. Preparation Stability schedule, protocol and summery sheet. Responsible for GLP related documents.
Preparation of Specifications, STPs & SOPs.
III) June - 2006 to Feb-2010 Orchid Chemicals & Pharmaceuticals Ltd. Jr.Executive-QC
A professionally managed fast growing Pharmaceutical Company having its manufacturing facilities at different locations in an around Aurangabad and Chennai, it sets up a 100% Export oriented Ultramodern API, Sterile and Granulation facility near Chennai to meet the requirement of its customers in USA, Australia, Africa, Canada, Japan and other European markets. The company is certified with US-FDA, MHRA, Danish Medical Agency, WHO-GMP, ISO 18001: 2007OHSAS and ISONumber Hidden Environment management Quality Certification,.
Job Profile:
Analysis as well as documentation of Stability Products as well as Holding Time Study Products. Preparation, analysis as well as documentation of Working Standards. Up-gradation of Stability Study Summary Data Sheet as per Regulatory Affaires. Preparation & up gradation of Stability Calendar. Preparation of Stability documents as per US-FDA, MHRA & cGMP norms. Well familiar with SAP system (QM - Module). Daily monitoring of Temperature & Humidity of Stability Chambers [Make: - Newtronic Equipments;
Software: - ICDAS Ver-2.1Data-Loggers]. Partially working in Review / Compliance team, for review of Documents [Finished products, Reaction
monitoring, IPQC docs, etc] and handling quality system documents like; OOS documents, Change Control, deviations, Laboratory investigations and OOT study in Stability studies.
Preparation, Co-ordination and implementation of SOPs, specification, STP and various types of Formats related to SOP.
Coordinating with R&D and PD Lab for Stability and Holding Time Study related issues. Coordinating with Regulatory Affaires and fulfilling their requirements with respect to filling of new drug
products and annual updating.
IV) Dec- 2004 to June- 2006 Midas Care Pharmaceuticals Pvt Ltd., Aurangabad Sr.Officer-QC
A professionally managed fast growing Pharmaceutical Company having its manufacturing facilities at Aurangabad, it sets up an Export oriented Formulation facility and pioneer in Aerosol technology (MDI-preparations). The company is certified with MHRA, TFDA, and Brazil Anvisa.
Job Profile:
Handled analysis and documentation of Raw Materials. Analysis and documentation of Bulk & Finished Products. Maintenance of Control Samples as per their storage condition and packing configuration. Maintenance of Chemical entry register & Glassware Calibration as well as record making. Analysis and documentation of on-going Stability of Finished products. Sound knowledge of Safety norms followed during handling of Lab chemicals and Steroids.
V) June- 2004 to Nov- 2004 JCPL Pharma Pvt.Ltd, MIDC, Jalgaon Officer-QC
A professionally managed fast growing Pharmaceutical Company having its manufacturing facilities at Jalgaon, it sets up an Export oriented Formulation facility. The company is certified with ISO: 9001 Quality Management System Certifications.
Job Profile
Chemical analysis of raw material as well as Intermediates and Finished Product. Handled Stability testing of Product. Preparation, Maintenance and Record keeping of volumetric solutions and other Laboratory Reagents. Instrumentation analysis of raw material and Product. Inventory control of lab chemicals and record keeping.
VI) May- June 2003 Blue Cross-Laboratories Pvt.Ltd, Nasik Inplant Trainee- QC
Job Profile:
Chemical & Instrumental analysis of Raw material and Finished Products Basic Microbial Techniques.
Instruments Handled:
H.P.L.C (Agilent 1100 and 1200 series) (Software: Chemstation) R.R.L.C (Agilent 1200 series) (Software: EZ-Chrome elite) H.P.L.C (WATERS 2650 series) (Software: Millenium2000 & Empowers2) H.P.L.C. (Shimadzu) (Software: Class-VP). Spectrophotometer (Perkin Elmer Lambda650 & Lambda25 & Cientra 10e) KF Autotitrator (Swiss made Metrohms) AAS (GBC 932 Plus) (Software: GBC Avanta) Rudolphs Autopol Polarimeter. Well versed with operating systems like Windows 2003 & Windows XP Professional and software
packages like MS-Office Word & Excel.
Personal Skills:-
Sincere, Self-motivated, hard working & capable of working in deadliness. Team player can motivate others to achieve objectives. Effective communicator can interact at all hierarchy levels effectively. Anxious to learn new things
Languages known:-
Can speak & write fluently in English, Marathi and Hindi.
Personal Information:-
Address : - c/o Plot No. 8, ‘Kolhe Niwas’,
Behind ADCC Bank,
Prabhat Colony, Adalat road,
Aurangabad-431 001
Date of Birth : - 2nd April 1982
Marital Status : - Married
I declare that the information given above is true to the best of my knowledge.
Place:
Date: -
(Patil Supriya Pravin)
Thomas Warren2715 Brenan AvenueHouston, Texas 77550
Telephone:1-409-555-1212 HomeEmail: [email protected]
SEEKING CHEMIST POSITION IN PHARMACEUTICAL INDUSTRY
SUMMARY OF QUALIFICATIONS
* Supervisory Experience* Creative Problem Solver
* Training Experience* R&D Lab Experience
EDUCATION & CERTIFICATIONS
Bachelor of Science in Chemistry - University of Texas, Austin, TX Computer Skills: MS Word, Internet, Power Point, Excel, Publisher
PROFESSIONAL EXPERIENCE
Hunt-McCall - Houston, TX 2003 to PresentLaboratory Manager
Maintained lab schedule, budget and compliance Calibrated and maintained equipment Trained analysts on lab methods
APP Labs: Trenton, NJ 2000 - 2003Senior Scientist
Prepared technical documents such as reports, operating procedures, methods, transfer and study protocols
Directed other employees, assisting in career development Established work priorities for assignments of my team Managed all stages of method development and validation
McGregor; Trenton, NJ 1998- 2000Scientist I
Validated and maintained equipment Responsible for method development and validation Prepared study protocols
Thomas, Inc.; Houston, TX 1996 - 1998Chemist
Performed quality control analysis of narcotics Validated and maintained equipment Performed lab testing
Summary:Research Scientist with strong background in Analytical Chemistry and excellent accomplishments in the fields of environmental pollution, food contamination, petroleum analysis, natural products analysis and water quality etc. 60 publications in international refereed journals. Considerable experience of managing analytical laboratories, project staff and quality control/quality assurance department. Core Competence: Research in the fields of environmental pollution, food contamination, instrumental chromatographic analytical techniques (GC, GC/MS, HPLC, Spectroscopy), analytical method development, scientific projects management and execution, management of analytical laboratories.
EXPERIENCEChief Executive Officer 2003 - PresentMidas Chemical Industries Limited(Chemical manufacturing industrial unit, employing over 100 employees). • Manage the completion of the chemical plant for the production of glacial acetic acid.• Supervise the commissioning of the plant.• Select and recruit the technical team to undertake trial runs.• Manage the finances of the company.• Negotiate with the financial institutions for funds.• Negotiate with the regulating agencies.• Supervise the day-to-day running of the company’s affairs.
Research Scientist 1992 - 2003Environmental Sciences Department Kuwait Institute for Scientific Research (Prime scientific research institute in the Arabian Gulf region, employing about 150 scientists and 1300 employees). • Identified and developed research ideas. • Prepared the project proposal documents submitted to the funding agencies. • Executed the approved projects. • Participated in other projects for the assigned tasks. • Supervised the analytical work for the different projects. • Carried out R&D work to improve the existing analytical methodologies and instrumentation. • Trained the staff for latest analytical methodologies.
Quality Controller 1990 - 1992Glaxo Laboratories Pakistan Limited, Lahore Pakistan (Multinational pharmaceutical company, primary manufacturing facility, employing more than 1500 employees). • Responsible for testing and sentencing of raw materials, intermediates and finished products.• Managed Quality Control Department's budget, facilities, instrumentation and manpower.• Additional responsibilities included were environmental and occupational health monitoring.• Developed, validated new analytical methods. Prepared Analytical Manual for the department.
Head Chromatography Section 1982 - 1990Kuwait Institute for Scientific Research Central Analytical Laboratory• Managed the section’s analytical services to other research groups.• Carried out R & D to develop/ adopt newer analytical methods.• Developed and conducted several training workshops for instrumental chromatographic techniques.• Prepared analytical manual for the methods used in the section.• Developed career strategies for the staff.
EDUCATIONPh.D. Analytical Organic Chemistry. University of Gent, Gent, Belgium, M.Sc. Organic Chemistry Punjab University, Lahore, Pakistan. B.Sc.(Honors) Chemistry Punjab University, Lahore, Pakistan.
AREAS OF SPECIALIZATIONEnvironmental analytical chemistry, food analysis, gas chromatography coupled with mass spectrometry (GC/MS), high-performance liquid chromatography (HPLC), trace metal analysis, high-resolution gas chromatography for the analysis of environmental samples, food materials, petroleum products, pollutants, pesticide residues and water. Quality control of pharmaceuticals, food preparation etc
Neeraj S.
+ + , Education: M.Sc. in Organic Chemistry in the year
Career Highlights: TechnoCommercial Professional with proven
from Kanpur University. Post Graduate Diploma in Business Management in from Bharatiya Vidya Bhavan, Mumbai.
Approvals:
Chemical & Physiochemical Analysis, Instrumental Analysis, Microbiological Assay, Pyrogen, Toxicity, Sterility & Lal Test. FDA – Gujarat, Punjab Jammu & Kashmir
Countries Visited:
US, UK, Russia, Cyprus, Germany, France, Italy & Singapore
Area of Exposure:
Chemical Analysis Microbial Analysis Instrumental Analysis Calibration & Validation Projects/Technical Quality Management System International Regulatory Affairs cGMP Validation DQ, IQ, OQ, PQ & PV Analytical Development ICH Guidelines Internal Audits Self Inspection Training & Change Control Project Implementation Vendor Analysis & Development for Out Sourcing Material Management Impurity Profiles Stability Studies/ Trend Analysis Dossiers / DMF’s Preparation & Submission Packaging Materials Document Control System Market Complaints Business Development
capabilities to work as QA, QC & RA Head / SBUHead / UnitHead / BusinessHead in Pharmaceutical Industry. Steering functions with over Years of Experience in the fields of Business Development/Customer Relation, Projects, cGMP, Validations, CMC, CRO, CRAMS, Technical, Operations, Quality Assurance, Quality Control, International Regulatory Affairs, Training, GxP, Compliances and Vendor development at various levels in Bulk Drugs and Formulations Business for out sourcing.. Worked in various capacities with renowned organizations such as Ranbaxy, Searle India, Ajanta Pharma, Cadila Pharma, Alkem Laboratories Ltd., Aurobindo Pharma, Phlox Pharmaceuticals, & Dishman Chemicals & Pharmaceuticals Ltd. Presently taking assignments as Consultant with Big Size, Medium Size Companies in India and abroad and taking care for QA, QC Sterile and Non Sterile, Regulatory, Project, Technical, Operations and Business Development activity. Getting involved for the over all manufacturing for API as well as dosage forms for all international business activity for Technology Transfer from R&D to Pilot plant to Manufacturing, QA, QC Sterile and Non sterile, RA activity, deeply involved for the customer as well as international regulatory audits, supply chain management to meet the requirement of three month rolling plan and out sourcing. ANDA / Dossier submissions DMF & CEP submissions Getting involved for the cost reduction activity in the process optimisation and yield improvement and by packaging development. Leading the team of around employees in staff, management level. QA & Regulatory Compliances cGMP Compliance Risk Management Helping developing the business in regulated market for API and Dosage forms. Eradicated the contamination problem from Fermentation process. Leading a team of Scientist, Microbiologists and Technologists to improve the productivity of Statins and Penicillin drugs. Deeply involved to improve the productivity as well as Quality of Fermentation Betalactum, Macrolites and Statins.
Technical/Operations CRO/CRAMS/CMC QbD Risk Management PAT
Working with the companies having the plants are FDAUS, EDQM, MHRA, WHO, ISO and approved or planning to go for such approvals in later stage.
Audits and Inspection for out sourcing, contract manufacturing
Prior to Consultancy, worked as Vice President – Quality Operations with M/s. Cadila Pharmaceuticals Ltd. As a SBU’s core committee member for Profit Centre. Responsible for maintaining the proficiency in Technical, Business Development, Projects apart from QA, QC and RA activities for R&D Centre, Formulation Plant & CRO at Dholka, Ahmedabad. Responsible for complete administration of the API manufacturing plant based at Ankleshwar in Gujarat. Initiated the activities for strategic alliance with top ten major generic companies of the world and presently have business with six out of these top ten companies. In the year , filed DMF in US markets, to EDQM, to TGA etc. in the rest of the world including South Africa. Recently faced AIFA audit for getting the approval to sell molecules in Italian market and seven other molecules are in pipeline to get approved. Present plants are approved with MHRA, MCCSA, WHOGENEVA, TGA AUSTRALIA and USFDA. Prior to Cadila, worked as Vice President Quality Operations and GBU Global Business Unit Head with IndSwift Laboratories Ltd. Handled Projects of Dosage forms, New R&D centre and API right from pilot scale to fullfledged plant to enter in the regulated market. Handled approval and developments for up coming Dosage form plants for MHRA & MCC South Africa. Responsible for giving inputs for existing plants which are USFDA, MHRA, TGA approved. Faced Regulatory Inspections like US FDA, MHRA, MCCSA, WHOGENEVA, AIFA, WHOGMP, NDAUGANDA, Customers Audits API & Dosage Forms, etc. Given proper training on instrument like IR, UVVIS, GCHS, GCMS, HPLC, HPTLC, LCMS/MS and Prep. HPLC. Will be able to assist the organization for the preparation, submission and approval of ANDA's and its amendments, supplements, annual reports in USFDA, Marketing Authorization Applications in European Countries.
Accountable for representing the company in meetings with health officials of various countries including US & Europe, handling registration for formulation products in regulated as well as third world countries markets and devising registration strategies to assure product launches according to the plan etc.
Experience:
Currently taking assignments as Consultant to take care for QA, QC, RA, Projects, Technical, Operations and Business Development for Big, Mid and Small size API and Dosage Forms companies of India and Abroad.
From February till date
Worked with Cadila Pharmaceuticals Ltd., Ahmedabad as a Vice President – Quality Operations
Reporting to President and Managing Director
September to February
Worked with IndSwift Laboratories Ltd. Chandigarh as a Vice PresidentQuality Operations & GBUHead
Reporting to Managing Director
August to September
Worked with Dishman Chemicals & Pharmaceuticals Ltd. Gujarat as a President Corporate Quality & Regulatory Affairs
Reporting to Managing Director
August to August
Worked with Phlox Pharmaceuticals Ltd. Gujarat as a Vice President Quality & Regulatory Affairs
Reporting to Chairman
December to August
Worked with Aurobindo Pharma Ltd., Hyderabad as a Senior Manager, Corporate Quality and Regulatory Affairs.
Reporting to Chairman & Managing Director.
September to November
Worked with Alkem Laboratories Ltd., Mumbai as a Senior Manager Quality Assurance
Reporting to Managing Director
June to Sep
Worked with Cadila Pharmaceuticals Ltd., Ankleshwar as a Senior Manager – Quality Assurance
Reporting to President
July to May
Worked with Surkhan Ajanta Pharma Ltd., Tashkent, Republic of Uzbekistan as a Quality Assurance Manager.
Reporting to Chief Executive Officer
April to June
Worked with Searle India Ltd., Ankleshwar as a Quality Assurance Manager
Reporting to Corporate QA Manager
September to March
Worked with Ranbaxy Laboratories Ltd., Delhi & Dewas as a Quality Assurance Supervisor.
Reporting to Quality Assurance Manager
April to August
Job Profile:
Business Development / Out Sourcing Developing periodic business plans & strategies in coordination with macro plans of organization. Planning & scheduling individual/ team assignments to achieve the pre set goals within time, quality & cost parameters.
Developed new business through prospecting for potential clients and meeting with executive level decision makers. Identify and develop international clientele for new business alliances. In charge of participation of conferences, international business fairs and other brand building activities on behalf of the company. Identify and develop the vendors for the out sourcing of the API, Advance Intermediates. Technical / Operations: Formulating long term/short term strategic plans to enhance operations Handling all Technical related matters pertaining to Regulated, NonRegulated and Domestic Products Providing technical support to R&D in troubleshooting, designing and development of products. Assisting R&D in speedy launch of the products from Pilot scale to Production level at all the manufacturing sites including Loan Licences and Third parties Supply chain management Quality Assurance: Designing and setting up the Quality Assurance System Acted as a Head during USFDA Pre Approval Inspections and final Inspections Involved with the GMP Compliance Program Conduct Quality Assurance audits / selfinspections Preparation of SOP’s Approval of Vendor Qualifications Approving authority for specification of equipments, instruments, systems to be procured Training on cGMP and other Issues Change control committee incharge. Actively involved in the design and construction of pharmaceutical manufacturing facility to comply with the regulatory requirement of USFDA and other regulatory agencies Interaction with Manufacturers, Suppliers and Vendors KAPA
&n
SAFIEA D. S.KitleyAvenuePickering,ON, LV LOBJECTIVE: To obtain a position as a Quality Assurance AssociateHighlights of QualificationsOver years’ experience in the Canadian Pharmaceutical Industry• Experienced Quality Assurance Professional and Analytical Chemist• Conducts thorough QA Compliance Audits of Processes while adhering to all SOP
regulations• Documents results and observations: Writes detailed, accurate reports for managers andcolleagues• Welldeveloped Project Management skills with strong trouble shooting and problem solvingskills• Clear, articulate communicator: Excellent interpersonal, verbal, and written communicationskills• Productive and responsible team player: Embraces challenges and enjoys learning new things• Proven ability working in fastpaced deadline environments managing multiple tasks• Computer savvy: Proficient in: Microsoft Word, Excel, Outlook, Watson LIMS, Analyst..CAREER HISTORYSGS Canada Inc Mississauga, ONSampler / Inspector • Collected food product samples according to the ‘Food Safety Action Plan’ for the CFIA• Researched and prepared product sample information and wrote detailed, accurate and timelyreports• Strictly practiced safe food handling methods ensuring samples adhered to Health CanadaSOPs• Stored and shipped samples according to label requirements to ensure integrity of productsAnapharm – Richmond Hill, ON– Quality Assurance Associate – • Reviewed and verified all data generated during biological analysis and validation activities• Verified and issued QA Releases to Laboratory Director and Project Coordinators• Adhered to policies, protocols, SOP, GLP, GCP, GMP, and external regulatory standards• Ensured that deadlines were met and quality standards were consistently maintained at %accuracy• Closed projects for submission with % accuracy enabling final reports to be issued ontime• Accurately issued reanalysis requests ensuring that quality, time, and costs were notcompromised• Consulted and communicated closely with other departments to ensure integrity of data andprocesses• Verified the preparation of projects’ solutions preventing the use of erroneous solutions anddata• Provided direction, support, and followup to laboratory personnel to correct SOP deviations• Effectively managed project issues and assisted in identifying and fixing documentationerrors• Identified errors and implemented effective solutions which resulted in saved money andresources• Prepared, presented and trained colleagues on QA and proper Essential Documentationprocedures• Conducted QA audit of inprocess work to ensure compliance• Assisted with client and FDA auditsSAFIEA D. S.
CAREER HISTORY continuedAnalytical Chemist, Anapharm – Richmond Hill, ON – Analytical Chemist, Biovail Corporation Toronto, ON– Sample Custodian, Biovail Corporation Toronto, ONReported to the Bioanalytical Project Coordinator, extracted and analyzed samples adhering toSOPs, FDA, GLP, and GMP regulations while meeting rigid deadlines• Expert use of automated liquid handling system Multiprobe, Perkin Elmer, and LCMS/MSinstruments MDS Sciex API and • Acquired extensive experience with Waters Automated HPLC, completed laboratorydocumentation for assigned projects, prepared several analytical reports and SOP• Responsible for the receipt, distribution, tracking, and proper storage of all biological samples• Performed optimization and mass determinations identifying and implementing effectivesolutions• Assisted in the development and validation of methods producing robust and reliable results• Trained new employees on all aspects of sample preparation, laboratory policies andprocedures• Performed various administrative duties such as maintenance of logs and preparation of finalreports• Established, organized, and maintained computerized logging and inventory systems forreference standards in compliance with audit requirementsEDUCATION and PROFESSIONAL DEVELOPMENTWHMIS Certified Anapharm, Richmond Hill, ON GLP and GCP Trained Anapharm, Richmond Hill, ON Information Technology Honours DiplomaDeVry College of Technology Toronto, ONBiological Chemical Technology Diploma Seneca College of Applied Arts and Technology Toronto, ON
ESUMEK. KUMARA SAMI RAJAF-2, SRI SAI HOMES59 & 60 A, Sri Dhenugambal nagar II street,Madambakkam, Chennai-600073e-mail : [email protected] : 9443790060
CAREER OBJECTIVETo associate myself with a reputed Pharma company where I can explore my knowledge and ability, to improve my knowledge and to be a part of the team that works dynamically towards the growth of the organization
EDUCATIONAL QUALIFICATION
o M.Sc., Chemistry from Annamalai university (May2008/First Class)o B.Sc., Chemistry from University of Madras (April1993/First Class)o Diploma in Industrial safety from Annamalai University (April 1996/ First Class)
DESIRED TECHNICAL SKILLSo Knowledge of principles and operations of all major analytical instruments and equipments such as HPLC, Gas Chromatographs, Spectrophotometers (UV / IR), Optical emission spectrophotometer, Polarimeter, Titrators, stability chambers etc.o Knowledge of analytical method development and validation.o Total QC/QA activities including analytical assurance, stability, QA/QC documentation, review, release & developmental quality assurance etc.,
Work experienceo A total of ~16 years experience in the QC & QA department of Pharmaceutical bulk Drugs (Sterile & non sterile)
Present employment: (From August 2007 to till date)o Working as Deputy Manager-Quality control – Actavis Pharma – Alathur, Chennai.
Key Responsibilities in Actavis Pharma:o Planning & execution of complete Quality control functions and Analytical Quality Assurance to comply with all regulatory requirements.o Planning & execution of Complete stability program.o Planning & execution of Documentation, review and release of finished product, intermediates, and stability samples.o Ensuring compliance as per cGMP/GLP requirements.o Planning & execution of Analytical method transfers.o System implementation in QC to comply USFDA standards and to comply other regulatory & customer audits.o Preparation, review and execution of quality control procedures, protocols & reports.o Overall Planning,o Laboratory investigations/deviations, OOS & OOT etc.o Establishing a new quality control set up to comply regulatory audits.
Past Experience I: Duration: December 2005 to August 2007
Organisation : ORCHID CHEMICALS AND PHARMACEUTICALS LTD.(An US-FDA, MCA, Australian TGA, MHRA, ISO-9001:2000,ISO-14001:2004, EDQM certified Company)Chennai. Tamil NaduDesignation : Senior Executive / Overall In charge –Quality control.
Key responsibilities in Orchid- QC: (From August 2006 to August 2007)o Worked as an overall In charge – Quality control.o Responsible for All QC activities related to Analysis, Review, Documentation & Approval for
all intermediates & finished products.o Planning and execution of all quality control activities.o Preparation and execution of quality control procedures, protocols & reports.o Work allotment, laboratory investigations/deviations, OOS & OOT etc.o Responsible for 21CFR Part 11 compliance.
Previous responsibilities in Orchid: (From Dec-2005 to Aug-2006)o Worked as In charge- Stability labo Total stability study activities with GLP/GMP compliance.o Planning of analysis on daily, monthly and yearly basis.o Preparing laboratory investigations for deviations.o Preparation of monthly and yearly Calendarso Preparation and execution of quality control procedures, protocols & reports.o Calibration and qualification of stability chambers and other analytical instruments.o Regular monitoring of stability conditions and maintenance of stability chambers.o Responsible for charging and distribution of stability samples.o Preparation of stability study reports.o Review of analytical data.
Past employment- II: Duration: Dec-1994 to Dec-2005
Organization : Shasun Chemicals and drugs Limited (API unit)(An US-FDA, ISO-9001:2000, ISO-14001:2004, EDQM certified Company)Pondicherry-605014Designation : Manager -Quality Controlo Worked as second line to Quality control DGMo Preparation, execution, of quality control procedures/protocols.o Analytical developments, performing analytical method validations, qualifying the analytical instruments, Supervision, Analysis and review of documents and coordinating the Quality Control section.
Key Responsibilities- at Shasun.o Analytical method validations – Preparation of protocols, and execution of Validation exercises and Preparing AMV reports.o Qualification of analytical equipments.(DQ,IQ,OQ &PQ)o Total Stability managemento Performing Cleaning validations for swab and rinse samples.o Calibrations and performance check of laboratory analytical instruments.o Work allotment.o Responding to the customer complaints.o Planning against Dispatch scheduleo Analysis of finished products as per the pharmacopoeial monographs.o Analysis and review of competitor’s samples and determining the appropriate grades for the commercial supply.o Preparation and Qualifications of internal reference standards against pharmacopoeial
reference standardso Review, analysis and documentation related to dispatch.o Approving Certificate of analysis and all relevant documents.o Responsible for 21 CFR part –11 compliance, with audit trails.o House keeping.o Supporting salvaging committee Investigation and execution of OOSo Member in the quality circle forum of India (Madurai chapter)
Accomplishments:o Successful completion of 7 USFDA (4- in Shasun + 1-in Orchid + 2-in Actavis) audits and many other customer/regulatory audits.o Analytical method validations for raw material solvents and intermediates for Ibuprofen.o Leaded and implemented the current practices of GMP and GLP.o Designed and implemented the procedures in accordance with USFDA and other regulatory requirements.o Involved in the laboratory setup of Instrumentation lab & wet lab.o Certified as Internal Quality Auditor as per ISO 9001:2000 standards by QSR
STRENGTHSo Highly motivated and result oriented professional with strong analytical and team building skills.o Analyzing, Identifying and Solving Problems Effectively.o Have proven skills in all given areas.o Ability to convert technical skills into practical applications.o Good exposure in management, planning and presentation skills.
Instruments well versed:o Waters HPLC with empower software with 21 CFR part 11 complianceo HPLC-2010 -LC solution software & class VP integrator (With audit trail system)o HPLC – Prominance with LC solution software – Shimadzuo UV (UV 240PC) – Shimadzuo FTIR – Perkin Elmero ICP-OES (Inductively Coupled Plasma – Optical Emission Spectrophotometer)-Perkin Elmero GC Agilent with Empower softwareo GC 2010 -– Shimadzuo GC (Perkin Elmer auto system) with GC 10 software.o Malvern Particle size analyzero Autopol Polarimetero Calibration, qualification & maintenance Stability chambers
Personal details:o Date of Birth/Age : 28-03-1972/ 38 yearso Nationality : Indiano Languages Known : Tamil & English (Read/write/speak)Telugu (To Speak)
o Marital Status : Married
o Address for communication : K. KUMARA SAMI RAJAF-2, SRI SAI HOMES59 & 60 A, SRI DHENUGAMBAL NAGAR – II STREET,MADAMBAKKAM, CHENNAI-600073Mobile no: 9443790060
o Permanent Address : 1-3, Arimalai (Post),Guruvarajapalayam(via), Vellore (Dt), 632107, Ph: 04171-252336o E-mail : [email protected]
Referenceso Dr. Dhamodharan – Director-QA, Ranbaxy-India (Mobile no:09876073650)o Mr. S.Sivagnanam- Director-Regulatory Affairs, Eckhart Corp.(Mobile no: 09871511662).o Mr.A.Srikanth –Quality control CIPLA-Bangalore,( (Mobile no: 09845902595)
Declaration:I here by declare that the above-furnished details are true and correct to the best of my knowledge and belief.(K.Kumara sami Raja)
K.KUMARASAMIRAJA
GMP Question and Answers
Why is GMP important?
Poor quality medicines are not only a health hazard, but a waste of money for both governments
and individual consumers.
Poor quality medicines can damage health
A poor quality medicine may contain toxic substances that have been unintentionally added. A medicine that contains little or none of the claimed ingredient will not have the intended therapeutic effect.
GMP helps boost pharmaceutical export opportunities
Most countries will only accept import and sale of medicines that have been manufactured to internationally recognized GMP. Governments seeking to promote their countries' export of pharmaceuticals can do so by making GMP mandatory for all pharmaceutical production and by training their inspectors in GMP requirements.
What is GMP?
Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. The main risks are: unexpected contamination of products, causing damage to health or even death; incorrect labels on containers, which could mean that patients receive the wrong medicine; insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects. GMP covers all aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made. WHO has established detailed guidelines for good manufacturing practice. Many countries have formulated their own requirements for GMP based on WHO GMP. Others have harmonized their requirements, for example in the Association of South-East Asian Nations (ASEAN), in the European Union and through the Pharmaceutical Inspection Convention.
Is GMP necessary if there is a quality control laboratory?
Yes. Good quality must be built in during the manufacturing process; it cannot be tested into the product afterwards. GMP prevents errors that cannot be eliminated through quality control of the finished product. Without GMP it is impossible to be sure that every unit of a medicine is of the same quality as the units of medicine tested in the laboratory.
Can manufacturers afford to implement GMP?
Yes. Making poor quality products does not save money. In the long run, it is more expensive finding mistakes after they have been made than preventing them in the first place. GMP is designed to ensure that mistakes do not occur. Implementation of GMP is an investment in good
quality medicines. This will improve the health of the individual patient and the community, as well as benefiting the pharmaceutical industry and health professionals. Making and distributing poor quality medicines leads to loss of credibility for everyone: both public and private health care and the manufacturer.
WHO works to strengthen GMP
WHO GMP guidelines are available online. If you require more information, please contact the WHO representative in your country, your WHO regional office or WHO headquarters in Geneva.
Quality Assurance (QA) Management Procedures
In this episode you will find Standard Operating Procedures for establishing quality assurance practices, such as preparation, maintenance, definition, classification and change Control of Quality and Master file documentation necessary for your products; recording and reporting procedure for deviations management; quality concern investigation Process; customer complaint handling procedure; quality audit procedures; vendor assessment, evaluation and
certification procedure; rework procedures for the defective manufactured products; procedures on training for your staffs and many other procedures according to your need.
All procedures have reference of prepared Forms and Templates for effective record keeping and reporting purposes. Forms are attached at the end of each procedure. Templates are listed separately.
SOP list
Writing Standard Operating ProcedureThis SOP describes standard SOP format that you can create and use immediately for your quality procedures. This SOP has instructions on how to write a formal Operating Procedures for your systems which your people can follow everyday.
GMP DocumentsIn this SOP you will find all type of quality and Technical/Master file documents to build up a good quality management system for your manufacturing sites, definition of documents, their classification, approval requirements and retention requirements. This procedure has schematic diagrams for your understanding of how different types of documents are prepared and stored in a typical documentation database.
Quality Documentation Change ControlThis SOP describes how to generate new quality documents or change control of existing documents, review of quality documents, satellite file management, role of document author, approver, document control officer and satellite file administrator. In this SOP you will also find numbering systems of different quality documents like audit files, SOPs, forms, manuals, training files, QA agreements, project files etc and their effective archiving system.
Documentation RuleThis SOP describes the principles to be followed in GMP documents, entry of data and information, signature requirements and correction technique of incorrectly entered data or information.
Document ControlIn this SOP you will find mainly the role of document control officer during the initiation, creation, circulation and approval of new quality related documents. It also describes the procedure of modification and review of existing document using a documentation database. Management of existing and superseded documents is also a part of this procedure. You will see all the forms referred during the instruction are attached at the end of the procedure.
Master GMP DocumentsThis SOP particularly focused on the management of master file documents like specifications, control methods, raw materials, finished goods and packaging specification and test reports, formulation, stability files etc required to generate during the product registration in the market. This SOP gives instruction on their creation, change control, numbering system, approval
requirements and maintenance in a simple master file database. You will see all the forms referred during the instruction are attached at the end of the procedure.
Deviation ReportingIt is a regulatory requirement to capture all sorts of deviations evolves in your systems in order to maintain the continuous improvement of your processes and systems. This SOP describes how to categorize the deviations between production, audit, quality improvements, technical deviations, customer complaints and environmental, health and safety deviations. It describes the management responsibilities of initiating deviation, capture data, analysis, investigation, determination of assignable causes, generation of management report and initiatives to be taken on corrective and preventative actions.
Product Shelf LifeThis simple SOP describes the meaning of shelf life and provides direction on how to interpret shelf lives and storage conditions for your raw materials from the Certificate of Analysis, determining expiry date for your finished products by use of raw material date of manufacturing and their shelf lives.
Vendor ManagementThis SOP describes the procedure to be followed during the vendor assessment and vendor evaluation for purchasing of raw materials, critical and non critical packaging components, laboratory supplies, engineering supplies and imported finished goods from the vendor. These instructions are essential for approving prospective vendor.
Vendor CertificationThis procedure aims to describe the process by which a vendor may be certified to supply materials or services. This procedure applies to vendors that supply a material or service to be used at any stage of manufacture by operations. Here you will get the roles of each department in the process to certify an approved vendor.
Product ComplaintThis procedure covers the receipt, logging, evaluation, investigation and reporting system of all complaints received from customers for the marketed products. This SOP contains step by step instruction to be followed in the customer complaint management like numbering of complaint, registration, evaluation of complaints, determination of assignable cause for the complaint deviation, implementation of corrective and preventative actions, trending of complaints and handling of counterfeit products.
Product ReviewThis procedure provides a guideline to annual product review which is required to be performed for each product produced for the commercial market to evaluate data, trends and to identify any preventative or corrective action that would lead to product quality improvements and report them to management.
ReworkThis SOP contains the step by step instruction to be followed when the rework of an in-process or completed finished good is required. This SOP covers the reworks of in-process manufactured goods where new batch number is introduced for the reworked part and rework of manufactured finished good keeping the same batch number. This sop also describes how to create rework protocols for each individual case.
Product Identification and TraceabilityThe purpose of this SOP is to define the method used for the identification of all contributing materials that could affect product quality and to ensure their full traceability. Here you will find instruction on all the records and documents used for the identification and traceability of incoming raw materials and out going finished goods.
GMP AuditsThis SOP describes the process of planning, performing, reporting and follow-up of different audits for your systems like Internal Quality audit, Vendor audit, Environmental Health and Safety (EHS) audit, EHS workplace inspection, Housekeeping audit. This SOP also describes the process to be followed by manufacturing personnel during an audit from a Regulatory authority.
Batch DocumentationThis SOP describes the identification of all documentation relevant to a production process in the form of “Batch Documentation Checklists” and to ensure their collection by completion of the checklists by Authorized Persons. This procedure is based on an example of tablet packaging process described in the ‘Manufacturing’ category.
Batch Document Evaluation for ReleaseThis procedure describes the process of collection, evaluation and record of batch related document generated during the production of a batch before an authorized person can release the batch for sale. This procedure is based on an example of tablet packaging process described in the ‘Manufacturing’ category.
GMP TrainingThis SOP describes how to design and deliver GMP related trainings for your manufacturing staffs, training assessment design, recording of assessment and preparation of training reports.
GMP Training MaterialsThis simple SOP contains instructions on how to write training materials, identification of training requirements, available resources, preparation of training aid checklists for your manufacturing staffs.
House Keeping AuditThis SOP describes the requirements, checklists and reporting procedure on housekeeping audits. Individual checklist forms are attached at end of the procedure for different areas like process, laboratory, engineering stores, warehouses. This procedure also describes the handling of non-compliance found during the housekeeping audits.
Contract WorkThe procedure describes the management and control of contract work provided by the contractors for packaging and finished products for your company as well as control of contract works done by your company on behalf of others.
Raw Material and Packaging Components SourcingThe purpose of this SOP is to describe the process for approval of an external vendor/manufacturer supplying products to your company. It covers raw materials (including bulk products for subsidiaries and contract manufacturers), critical packaging components in contact with product and imported finished goods. The SOP also references affiliated documentation detailing the scope of active materials used and the approved manufacturers of these materials.
Quality Investigation ProcessThis procedure contains instruction to be followed when conducting Investigations and to raise and assess Deviation Report when an Investigation or Incident Investigation occurs. This procedure is to be used in conjunction with Deviation management, which covers the approval and follow-up activities associated with a Deviation Report. Here you will find collection of information for an incident or a deviation, steps to be followed for a cross functional investigation, reporting and implementing of the outcomes of investigation.
Change Management SystemThis procedure provides a standardised procedure and framework for initiating, authorising, planning and implementing any change to a GMP system.
Product Change Management requires that all planned permanent changes that have the potential to impact on regulatory filings or the quality of an active pharmaceutical ingredient or drug product must be evaluated, reviewed and approved. It also requires that the site procedure must include provision for effectively tracking all quality and regulatory changes and provide a mechanism for review and approval by the Site Quality Team for all changes
Cross functional investigationThis procedure describes the guidelines for initiating, communicating, conducting and documenting Cross-Functional Investigations (CFI) related to process, system, product, material, facility and laboratory deviations. A Cross–Functional Investigation is an extended investigation conducted in order to identify a Root Cause.
Quality Control Laboratory Procedures
In this episode you will find practical procedures on Retest Dating of Raw Materials; Calibration Policies for Laboratory Instruments; Archiving Laboratory Documentation; Management of Reference Substances; GLP requirements of Laboratory Workbook; Creation of Certificate of Analysis; Managing Analytical Reagents; Laboratory Waste Management; Managing of
Retention Samples in Laboratory; Laboratory Supplier Approval; Laboratory Results-Out Of Specification Investigation; Raw Materials-Laboratory Testing and Documentation; Finished Goods-Laboratory Testing and Documentation; Preparation and Maintenance of Stability Protocols (pharmaceuticals); Stability and Trial Testing Procedure (pharmaceuticals).
SOP lists
Retest DatingThe purpose of this procedure is to describe how to run the expired stock report; to describe how to define the requirements for the retesting and assignment of storage periods for active ingredients, excipients and raw materials; to instruct retesting procedure and to determine the status of a finished goods batch with a shorter shelf life.
Calibration of Laboratory InstrumentsThis SOP describes the calibration policies of laboratory instruments/ equipments. It describes labeling and security requirements of laboratory instruments/ equipments. This SOP also describes the investigational steps to be required in the case of failed calibration.
Archiving of Laboratory DocumentationThis procedure describes retention and disposal procedures of laboratory documentation, general laboratory documentation system that includes handling of rejected raw material and finished product reports, finished goods certificate of analysis, finished goods register, raw material certificate of analysis, raw material register, trend cards, procedure for long term document retention.
Reference SubstancesThis SOP describes the ordering, referencing, storing, coding, use and general register maintenance of primary and impurity reference substances, primary reagent reference solutions, secondary raw material reference substance, assay testing procedure of secondary raw material reference substance, use of secondary raw material reference substance in the laboratory routine analysis, determination of expiry date and re-test date of reference substances.
Laboratory WorkbookThis SOP describes types of laboratory workbooks, general and GMP requirements of using workbooks, analytical data entry in the workbook, formatting of laboratory workbooks for routine testing, experiments and trials, workbook retention policy, instruction on data entry for incomplete experiments and additional data.
Certificate of AnalysisThe purpose of this procedure is to define the content and format of a Certificate of Analysis (C/A) and Certificate of Manufacture (C/C) and to provide guidance for issuing a Certificate of Analysis or Certificate of Manufacture and to locate the appropriate data required for this task.
Analytical Reagents
This procedure identifies the need for all analytical reagents and solutions prepared from the reagents, to have an assigned expiry date and storage conditions recorded on the label. Here you will find the procedure for purchase and management of analytical reagents and laboratory prepared reagents.
Laboraotry Waste ManagementThis simple procedure describes how to dispose off laboratory generated wastes of toxic, explosive, flammable, corrosive, oxidizing and biologically damaging natures.
Laboratory Retention SamplesThe purpose of this SOP is to describe the finished good and raw material sample retention procedures, products manufactured and/or received onsite and/or chemically tested by the Laboratory.
Laboratory Supplier ApprovalIn this simple SOP you will find the procedures for approving laboratory suppliers and criteria for the purchase of equipment, instrumentation, consumables, durables and glassware for the laboratory.
Laboratory Results Out Of Specification InvestigationThis procedure describes the actions to be taken by an analyst in the event the result of a test does not conform to raw material/components or finished products specifications for physical and chemical tests. An out of specification (OOS) result does not necessarily mean the batch under investigation fails and shall be rejected. The OOS results shall be investigated and the findings of the investigation, including re-test results shall be interpreted to evaluate the batch and reach a decision regarding release or rejection.
Laboratory Testing for Raw MaterialsThis SOP describes the procedure for sampling, location, pre-testing, testing and documentation of all raw materials and components subject to test, out of specification results, microbiological tests and release procedure for passed raw materials and components.
Laboratory Testing For Finished ProductsThis SOP describes the procedure for sampling, location, pre-testing, testing and documentation of all finished products subject to test, reagents and standards to be used for analysis, management of out of specification results, microbiological tests and release procedure for passed finished goods.
Stability ProtocolsThis procedure describes the preparation and management of Stability Protocols for marketed products. This procedure is applicable to all protocols for stability studies on commercial products. The responsibility of the commercial Site Stability Manager for creating and maintaining protocols that are required for studies that came as a result of validation or process deviation.
Trial TestingTo describe the steps necessary to ensure the effective control of stability and trial testing programs of new and existing products. This procedure is focused on setting up of stability programs, testing, reporting, general sampling procedure for stability programs, data generation and analysis, annual maintenance of stability, new product stability procedure, procedure for in-house trials, reporting and interpretation of trials and conclusion of the trail program.
Preparation of Disinfactant Solution in the LabThis procedure describes the preparation and use of disinfectant solutions (70% IPA) in the Sterile Area and also outlines the procedure for Integrity testing of the 70% IPA Filter.
Laboratory Analytical DeterminationsThe purpose of this document is to describe the operational procedures to be followed when carrying out analytical analyses in the Quality Control Laboratory at a GMP site. This SOP outlines the system suitability (SST) and acceptance criteria for analysis by HPLC and UV-VIS Spectrophotometer; e.g. Composite Assay (Assay), Degradation Products / Related Substances / Impurities (Degradation), Content Uniformity (CU), and Dissolution tests for all Raw Materials, In-process, Finished Products and Stability Samples in the QC Laboratory. This SOP also covers the number of standard and samples to be weighed for HPLC and UV-VIS Spectrophotometers analyses.
Microbiology (Sterility) Laboratory Procedures
In this area you will find Standard Operating Procedures on Entry Procedure to Sterile Filling Areas, Validation of Aseptic Gowning Procedures, Microbiological Data Recording Procedure, Destruction of Biological Waste in the Microbiology Laboratory, Depyrogenation of Glassware In Micro. Lab. Oven, Media Preparation in Microbiology Laboratory, Aseptic Media Filling and Micro. Integrity Leak (Soup) Testing Procedure, Aseptic Media Filling and Soup Test Guideline, Environmental and Plant Hygene Monitoring Procedure, Microbial Limit Testing Procedure by Using Laminar Flow Cabinets etc and many other procedures according to your need.
All procedures have reference of prepared Forms and Templates for effective record keeping and reporting purposes. Forms are attached at the end of each procedure. Templates are listed separately.
SOP List
Sterile EntryThis SOP outlines the gowning procedure that must be followed by each and every person who enters a Sterile Area. The procedure is designed to reduce the risk of contaminating product with bacteria and/or particles
Aseptic Gowning ValidationAseptic gowning is the ability to complete the gowning procedure without compromising the sterility of the garment. This SOP outlines the sterile gowning validation procedure as required for the final sign off for the initial sterile training and the revalidation of currently trained Operators, Fitters, Electricians and Cleaners and all organization staff who are authorized to enter Sterile areas.
Microbiological Data RecordingTo describe procedures for the recording of Microbiological data using the in-house hard copy and computerized recording system. All documents containing test results are legal documents and therefore it is imperative that all the information required is recorded accurately. Any changes/corrections to be made must be signed with that person’s initials and dated.
Biological Waste DestructionTo describe procedures for destroying all Laboratory Biological Waste to comply with Quarantine Regulations
Depyrogenation of GlasswareTo outline the procedure for the depyrogenation of glassware using the Microbiology Laboratory Qualtex Oven.
Media PreparationTo describe the procedures for the preparation of microbiological media for use in the Microbiology Laboratory.
Micro. Integrity Leak (Soup) TestingOne of the requirements of cGMP is a periodic evaluation of all aseptic processes by filling media into the appropriate containers under normal production conditions. The media fill should reflect the sterility of the entire process from the Sterilizing filter to the filled primary container and should include all subsequent manufacturing steps. This SOP outlines the procedures for both Media Fills and Microbiological Leak Tests. For Validation purposes, a Microbiological Leak Test (Soup test) or a separate Protocol to verify the entire process from the ‘Bioburden Reduction Filter’ to the primary container may be required.
Aseptic Media Filling and Soup TestMedia Fills are designed to verify the entire process, equipment and staff. This process simulation should be performed as initial validation with three (3) consecutive satisfactory simulation tests per shift and repeated at defined 6 monthly intervals (twice per year per process per shift) and after any significant modification to the HVAC-system, equipment, process and number of shifts” for aseptically filled process. Soup test has to be conducted at least once per year per shift for terminally sterilised lines and non-sterile process. Validation and re-validation media fills are to assure the sterility of the entire process. This process simulation test should imitate as closely as possible the routine aseptic manufacturing process and include all the critical subsequent manufacturing steps. The Media Fill should challenge the “worst case”
situation and should include all the possible interventions of a normal production run. The duration of the media run should be at least 4 hours or half a production shift to allow for all routine interventions.
Environmental and Plant Hygiene MonitoringDescription for Microbiological testing of areas of the environment which may influence or affect product performance and/or quality-including, air, surfaces, personnel, clothing and disinfectants. Daily monitoring of sterile grade areas during production is to be conducted by trained production staff. The Microlab is to ensure that the necessary plates are delivered on a daily basis so monitoring can take place. Once a test has been completed, the responsible operator is to initial the plate and make sure that the batch number of the batch running at the time of the test is written on the plate. Plates will be labeled with prompts to ensure this isn’t forgotten. If no batch is running at the time of the test N/A should be put on the plate instead of a batch number. If an area of concern is noted during routine daily testing, inform Micro immediately so that further steps can be taken.
Microbial Limit Testing Using Laminar Flow Cabinets.To describe the procedures to be followed in conducting Microbial Limit Tests in the Laminar flow Cabinets in the Microbiology Lab.
Microbiological Monitoring of Plant Water SystemsIn this SOP you will find Sampling Procedure for Bioburden and Endotoxin Samples, Bioburden Test Method and Results, Endotoxin Testing of WFI (Distilled Water), Bioburden and Bacterial Endotoxin Alert and Action Levels, Diagrammatic Representations of a typical purified Water Systems, Bioburden Waste Tank Water Sampling, Clean Steam Sampling & Testing, OOL/OOS Result Actions etc
Sterility Testing ProcedureThis sop is to describe the procedure for sterility testing of aqueous, injectable and terminally sterilized non injectable products. To explain the correct interpretation of sterility results and to outline Stasis requirements for used sterility canisters.
Determination of Heat Resistance of Spore Forming OrganismsThis SOP describes the method for calculating the Heat Resistance Factor, (D-value),of spore-forming organisms. D-Value is defined as the time required for a population of a pure culture of microorganisms to be decreased by 90% when exposed to a fixed temperature, e.g. 121°C (+1°C).
Identification of Microorganisms to Genus and Species LevelTo describe the procedures for the preliminary identification of bacteria isolated from Plant Water, Environmental, Personnel, Product and Raw Material sources. Bacteria that will require identification (ID) to at least genus level include organisms isolated from the manufacturing environment, personnel, in-process and finished products, plant water and other miscellaneous sources. SOP’s detailing the microbiological testing procedures for each of these samples will
indicate the required level of ID of recovered organisms. The following sections detail the procedures for the preliminary ID of micro-organisms. Further ID to species level is to be conducted for conformation.
Micro Evaluation on Bioburden, Non sterile and Raw MaterialsThis SOP describes the procedures for Microbiological Evaluation of Bioburdens, non-sterile Products & raw materials. Bioburdens includes: Batches prior to membrane filtration, i.e. solutions; Batches prior to sterilization i.e. filled containers; Face masks; IPA. This procedure includes Equipment preperation for Non-sterile testing, Bulk Solution Bioburden (BSB) Sampling; Filled Container Bioburdens (FCB); Raw Material Bioburdens (RMB); Surgical Face Masks; Isopropyl Alcohol (70% IPA); Speciation Procedures for Organisms found in Non Sterile Products and Raw Materials; Out-of-Specification Procedures for Non Sterile Products and Raw Materials; Retest and Repeat Procedures for Non-Sterile Products and Raw Materials.
Bacterial Endo Toxin Testing (LAL) - Gel Clot MethodTo describe the procedure for conducting a Bacterial Endotoxin Test by the LAL Gel-Clot method. The gel-clot method for bacterial endotoxin testing described in this SOP is based on the fact that Limulus Amoebocyte Lysate (LAL) will form a firm gel in the presence of bacterial endotoxin.
Bacterial Endo Toxin Testing kCA MethodThe purpose of this SOP is to outline the theory of Bacterial Endotoxin testing using Kinetic Chromogenic Analysis (KCA). And to outline the procedure for routine product testing, operator / reagent verification and product validation by KCA using the BioWhittaker KQCL (brand) reader. This Procedure also describes the routine maintenance procedures for the BioWhittaker KQCL (brand) reader.
Stock Suspension of Micro OrganismThe objective of this SOP is: To describe the method for preparing and maintaining stock suspensions of vegetative microorganisms and spores used within the Microbiology Laborator;. To explain the procedure for growth promotion and media verification requirements for all media used within the Laboratory; To outline requirements for Stasis testing on sterility canisters after sterility testing has been completed.
Sterile Sampling Procedure for Microbiology LaboratoryTo detail the procedure for taking Microbiological samples for Sterility testing, Bacterial Endotoxin testing, Bioassay testing, Microbial Limit test and Micro status testing throughout Production. This procedure includes sterilization charts, Settle plates (Fallout plates) and Personnel monitoring.
Gel Clot Validation MethodThe gel clot validation method for Bacterial Endotoxin testing described in this SOP, is to determine the level of Inhibition/Enhancement of products on the LAL test for endotoxins within the allowable Maximum Valid Dilution (MVD) for each type of product. The Gel-Clot techniques detect or quantify endotoxins based on clotting of the LAL reagent in the presence of
endotoxin. To be determined for each type of product, using the highest and lowest concentration of active. If either concentration shows inhibition or enhancement, then each remaining concentration must be tested. At least three (3) Production batches of each finished product should be tested for inhibition and enhancement.
Laboratory Investigation for Atypical and OOS ResultsThe purpose of this procedure is to provide guidance when investigating microbiology laboratory out of specification (OOS) results associated with raw material samples, in-process samples and finished product samples. This procedure describes the actions taken by Microbiology Laboratory staff in the event the result of a test does not conform to company specifications for microbiological release. This procedure will also provide guidance for re-testing raw material samples, in-process samples and finished product samples when it has been decided through a laboratory investigation that retesting is justified. Retesting should be viewed as an investigational tool to aid in determination of the root cause of the discrepant laboratory result.
IPA Contamination Testing ProcedureTo describe the test sometimes used to check the purity of the IPA used in the factory as a disinfectant.
Control of Microbiology Test MethodsThis document details the writing, control, and distribution of Microbiological Test Methods (MTM) for use in the GMP Microbiology Lab. This procedure applies to Microbiological Test Methods that are controlled from beginning to end by the Microbiology Lab Manager.
Handling of Test Sample in Microbiology LaboratoryThis document details the handling of test samples (raw materials, bulk product and stability samples) processed for Microbial Limits Testing (MLT) in the Microbiology Laboratory. This procedure applies to samples tested for Microbial Limits within the Quality Control Microbiology Laboratory.
Documentation Requirement For Micro Test Method ValidationThe procedure describes the process for accessing and using protocol templates for documentation of test method validation activities in the Microbiology laboratories. This procedure applies to Microbiology personnel responsible for the validation or verification of microbiological test methods. The procedure outlines the requirements for approval of method development protocols, validation/verification protocols and final validation summary reports.
Process, Cleaning and Methodology Validation Procedures
In this area you will find procedures on validation-concept and procedure, revalidation procedure, method validation procedure, procedure for cleaning validation, validation of laboratory instruments, equipment specification and qualification and in-house trial procedure.
All procedures have reference of prepared Forms and Templates for effective record keeping and reporting purposes. Forms are attached at the end of each procedure. Templates are listed separately.
SOP list
Concept and Procedure of ValidationThis procedure describes general validation concepts and practices, the way processes and systems must be qualified/validated and the confirmatory documentation required. Here you will find the philosophy of validation, responsibilities, validation approaches of design qualification, installation qualification, operational qualification, performance qualification, cleaning validation, method validation, computer validation, general and specific criteria of validation, validation documentation and change control, validation reporting, guidelines of validation acceptance criteria.
RevalidationThis procedure contains step by step instruction on initiation of revalidation categories, changes that warrant revalidation programs, basic steps of revalidation procedure, revalidation activities and specific responsibilities, revalidation protocols, revalidation timing, equipment checklist, revalidation discrepancy procedure, release of revalidated equipment, preparation of the revalidation reporting file.
Method ValidationThis procedure provides a guideline for a validation Technician on the characteristics that must be considered during the validation of an analytical testing procedure. The procedures set out in this SOP apply to qualitative and quantitative analytical methods which are used to test finished goods, in-process material, excipients and raw materials in support of registration documentation and cleaning validations and management responsibilities towards completing those method validation tasks.
Cleaning ValidationThis SOP describes the types of cleaning process and cleaning agents of process equipments and their validation, complete instruction on cleaning validation procedure, calculation of acceptance limits for rinse and swab samples, calculation of acceptance limits for swabs, analytical method validation for cleaning, cleaning validation test protocols and change control for revalidation.
Validation of Laboratory InstrumentsThis procedure describes the validation practices for laboratory instrument/equipment to be validated or calibrated and the confirmatory documentation required showing that the instrument/equipment is capable and operating effectively for its intended purpose. This procedure has practical instruction on Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) to be performed by the qualified equipment service technician in the presence of the laboratory staff with reference to the instrument/equipment manual.
Equipment Specification and Qualification
This procedure describes in detail the procedures for the procurement of equipment, incorporating standardized demand specifications and Installation Qualification documentation, to ensure that equipment procured complies with in-house requirements and standards and conform to Good Engineering Practice, to detail the general procedure to be followed regarding the reporting of Factory and Site Acceptance Tests, to detail the manner by which the equipment Installation Qualification is documented.
In-House TrialThe purpose of this SOP is to define common procedures to follow when organizing Trials/Evaluation Studies for the purpose of process improvement, equipment capability and validation studies. It defines the responsibilities within the trial process and documents that need to be considered when preparing the Trial documentation to ensure that the trial meets GMP and where applicable validation requirements. This SOP defines the procedures for conducting in house stand-alone trials on systems, processes and equipment. There can be an overlap between a trial and validation in that Trial documentation may form part of a latter process validation, (i.e. concurrent and prospective validation) and qualifications (OQ, PQ).
Computerized Systems ValidationTo overview the procedure to be followed for the Qualification/Validation of computerized systems. This procedure applies to all computer systems (including embedded systems) directly associated with, or supporting, regulatory compliance requirements for the development, testing, manufacture and distribution of medicinal products.
Impact Assessment for Computerized SystemsThe purpose of this SOP is to provide a method of assessing and determining the validation requirements for computerized systems and controllers. The SOP identifies the typical qualification activities required for those systems having a Direct or Indirect impact on product/process quality and data integrity, should the system fail or malfunction. These activities are in addition to Good Engineering Practice (GEP), which is appropriate for all systems, and is also outlined
Functional Testing Guide for Computerized SystemThis SOP provides guidance on functional testing during the development or change of computerized systems which have GxP impact at a GMP manufacturing site. What constitutes a change to a computerized system is described in manufacturing change control procedure.
Design Qualification GuidelinesThe purpose of this document is to provide guidelines on conducting Design Qualification (DQ) during the conceptual and detail design phase for the implementation of a GMP facility, process and equipment (including computerized systems) to ensure conformance to operational and regulatory expectations. The guideline will provide the basis for conducting and documenting Design Qualification to all projects involving the introduction of, or significant change to, any facility, system or equipment that potentially impacts on product quality and is suitable for its intended purpose.
Protecting the Reliability of Electronic GMP Records
This SOP applies to records created, processed, used or stored by (or for) the GMP Manufacturing site, that are the output of a computerized system. It is of particular relevance to records that have a GMP role, i.e. supporting product quality, patient safety or regulatory compliance. The guideline may also be used for other computerized systems that are classified as business critical.
GMP | Manufacturing Procedures
In this area you will find exciting procedures on Clothing Requirements Inside the Factory Area, Cleaning Responsibilities and Methods for Employees, Factory Cleaning Procedure, Manufacturing Pest Control, Tours of Factory, Requirements of Production Logbook, Packaging Configuration for Production Line, Checking of Components Prior to Use, Tag Out Procedure, Procedures for Line Clearance, Line Opening and Line Cleaning, Reconciliation of Component and Product, Operation of Barcode Reader as an example, Intermediate Bulk Container (IBC) Operation and Cleaning, Tablet Packing Machine and Cartoner-construction, operation and cleaning as an example, Manufacturing Instruction for Tablet Packing as an example, Mop Cleaning Procedure, Scheduling Production Lines, Vacuum Leak Testing Procedure, Weighing Equipment - Checking and Calibration, Operation of Checkweigher as an example, Tablet Packing-Start up and In-process Testing as an example, Packed Tablet Sampling by Production Personnel for Testing as an example
All procedures have reference of prepared Forms and Visual Displays for effective record keeping and reporting purposes. Forms are attached at the end of each procedure.
SOP list
Clothing RequirementsThis SOP covers the clothing requirements needed in all Factory areas for your manufacturing site. The different levels of cleanliness must be maintained to minimize microbial and particle contamination. This procedure contains general rules and restriction to be followed by your manufacturing employees, defining different environmentally graded areas and entry requirements for those areas.
Cleaning Responsibilities and Methods This SOP describes the cleaning procedures to be followed by all employees working in the manufacturing area in order to prevent contamination of product by foreign materials from another batch, or by dirty parts, which may contain bacteria. This SOP contains instruction on responsibility of cleaning, degree of cleaning to be done, popular cleaning aids and solutions permitted to use for cleaning, rubbish removal and outline of cleaning methods for different environmentally graded areas.
Factory Cleaning
This SOP defines the methods, frequency and the intensity of Factory Cleaning. The purpose of cleaning is to remove debris from within the plant in a sanitary and effective manner and to avoid contamination from dust or foreign materials. This procedure describes which popular cleaning aids and solutions are to be used to clean the floors, walls, sinks and windows in the Production areas, office areas, change rooms, workshops, laboratories, stores, canteens, plus the toilet facilities. This procedure also describes the scope and responsibility of contract cleaners.
Manufacturing Pest ControlThis SOP describes the responsibilities of all employees and pest control services, classification of pests, frequency of the pest control service and effective treatments against all types of pest.
Production LogbookThis procedure outlines the generation, maintenance and filing of Production logbooks. Production logbooks form part of the documentation system required by the Code of GMP to provide complete and up-to-date histories of all batches of product. The logbook provides a key link in the process of traceability.
Packaging Configuration for Production LineThis SOP provides an alphabetically indexed diagram of shipper packing and pallet packing configurations for any packaging process. This procedure contains schematic diagrams of different packaging configurations and calculations of total unit to be packed per container which can be useable into your packing lines.
Checking of Components before UseThis SOP sets out a procedure to ensure that only components of correct code and batch number are issued for a batch and only issued components will be used in a finished product batch. This SOP also describes the procedure to be followed during returning of components to warehouse from the production lines.
Tag Out ProcedureThis SOP describes how to prevent the risk of personal injury or damage to equipment likely to be caused by operating or attempting to operate machinery or equipment diagnosed as being unsafe, in need of repair or maintenance or formally removed from service. The SOP covers all isolation, condemning, repair or maintenance work that necessitates a device or machine to be taken out of service. This SOP applies to any situation where energy (either supplied to equipment, or stored within it) needs to be isolated to ensure the safety of any person working on or near equipment, processes or services - for any reason whatsoever.
Line Clearance, Line Opening and Line CleaningThis SOP describes the procedure and order to be followed when performing a Line clearance, Line opening and Line cleaning for a batch production. The procedure has been established to prevent mix-ups of products, containers, components, labels and mistakes in documentations. Mix-ups and mistakes can occur when correct procedure and GMP are not followed. Particular care should be taken when starting a new operation, at the change of shift and when additional
components are needed. In this procedure you will find example of line clearance, opening and cleaning checklist based on an example of tablet packing line.
Reconciliation of Component and ProductThis simple SOP describes the concept of reconciliation, how to reconcile finished goods and determine the allowable discrepancies of components and products when reconciled.
Construction, Operation and Cleaning of Tablet Packing MachineThis procedure describes the machine construction and operation, machine start up and cleaning of a typical tablet Blistering machine and the Cartoner for tablet packing. You will be able to create a new procedure for your packing line based on the format of this SOP.
Manufacturing Instruction for Packing This procedure describes how to create a complete manufacturing instruction for your process line to be followed by your manufacturing employees. To make the instruction more practical and easy to understand, a sample instruction is added in the form of a protocol for a typical tablet packing process. All the related blank forms are attached at the end of the procedure for a better understanding.
Mop CleaningThis simple procedure outlines the operation of the factory laundry in a safe and hazard-free manner. This procedure can be used in any manufacturing site for the purpose of mop cleaning.
Scheduling of Production LinesThis procedure describes how to produce a monthly manufacturing schedule following an agreed 12 months plan, to provide a sequence of work that will enable the scheduling of support groups (i.e. Quality, Technical and Warehousing), incorporate any planned engineering down time (i.e. project work, calibration and preventative maintenance), create and release batches according to the agreed weekly schedule, provide key dates for product supply to support Customer Service.
Vacuum Leak Testing ProcedureThis SOP describes the set up and operation of a standard vacuum Leak Tester for the very popular vacuum leak testing used in a typical packing line.
Tablet Packing-Start up and In-process TestingThis procedure contains instructions that enable the production operators working in a typical packing line to carry out Start-Up and In-Process Tests required in order to produce quality products and to ensure in-process controls. A typical tablet packing process is used here as an example.
Finished Product Sampling for TestingThis procedure describes the process of sampling manufactured finished good required to be taken by production personnel for the laboratory testing. A typical tablet packing process is used here as an example.
Returning Components from Packaging FloorThis procedure describes the steps to be followed when there are packaging components to be returned to the warehouse after the packaging operation has been completed.
Warehouse Management Procedures
In this area you will find procedures on Receipt of Incoming Goods, Raw Material and Components-Incoming-Handling by Sampler, procedure for Warehouse to Processing Issues, Returns and Rejects, Dispatch of Goods from Warehouse, Warehouse Inventory Management, Warehouse Locations and Storage Area, Finished Goods Transfer to Quarantine and Distribution Warehouse, Sampling of Raw Materials, Sampling of Components and Printed Materials, Work in Progress Area, Safety Procedure of Warehouse Racking, Forklift Operation in Warehouse, Tablet Dispensary Procedure as an example, Raw Material Tablet Sampling by Dispensary as an example, Material Purchasing Information Record and Source List, Generation of Purchase Order For Inventory and Consumables
SOP List
Incoming GoodsThis SOP contains step by step instruction on condition of accepting incoming goods in the warehouse, ‘booking In’ procedure of component and non component goods, how to complete movements of incoming goods into different storage locations within the warehouse maintaining full traceability. Here you will find generation and filing of documents related to receipt of incoming goods.
In-coming Raw Material and Components HandlingThis procedure describes quarantining, sampling, testing and releasing of incoming raw materials to Production. Here you will find the labeling requirement for component to be sampled, checking requirements of components, sampling and re-sampling of incoming goods for laboratory testing, generation of documentation during the movement of components in order to maintain complete traceability.
Processing Issues Return and Rejects This SOP contains step by step instruction on issue of tested and QC released components for batch production, documentation needed for capturing identification and traceability information during the picking, assembling and transferring of those components from warehouse to production. This procedure also has instruction to follow during the return and reject processing of raw materials and components from production to warehouse.
Dispatch of Goods from WarehouseThis SOP contains instruction and documentation on movement of finished goods to quarantine until release for sale, dispatching procedure and documentation needed for transferring of finished goods from quarantine to warehouse store and subsequently to out side the manufacturing site maintaining a complete traceability of finished goods.
Inventory ManagementIn this procedure you will find a complete inventory management system by stock counting instruction, stock classification and reconciliation programs. Here you will find instruction on cycle counting by material code, counting by bin sheet information and reconciling/cross checking of those counts by physical counting of the stock, determination of material gain or loss and filing instruction.
Warehouse Locations and Storage AreaThis SOP is designed to understand and draw an schematic diagram of ideal warehouse and production areas, identifying in-coming goods storage unit types and storage bin types, quarantines, reject cage, cool room, flammable storage, dispensary booths, production area, finished goods quarantine area and finished goods storage areas. This procedure defines how storage unit types and storage bins are numbered. This SOP is to be used as a guide to define the types of storage units and bins, movement direction within the warehouse and production areas.
Finished Goods Transfers to areasThis simple SOP contains instruction and documentation on movement of finished goods from production to warehouse finished goods quarantine location until the samples are tested and released by the authorized persons.
Sampling of Raw MaterialsThis procedure primarily concerned with risk associated with sampling, precaution to be followed when sampling, general sampling procedures for raw materials, critical and non critical components, chemicals and secondary reference standards for laboratory.
Sampling of Components and Printed MaterialsThis procedure is an elaboration of SOP WAR-045 and mainly concerned with sampling plans and instructions of components and printed materials for quality testing before release for production use.
Work in ProgressThis simple procedure describes the construction and locations of different work in progress areas between production and warehouse for temporary storage of raw materials, component and finished goods.
Warehouse Racking This SOP outlines the measures to be taken to ensure the safety of all goods and personnel when using the storage racking system in order to avoid injury to staff or damage to property. This procedure concerned with the handling and storage of materials or products and to report any damage which may be occurred. This SOP particularly relates to the activities of the staff of the receiving and distribution warehouse.
Forklift Operation in WarehouseThis SOP gives instructions on operation requirements and maintenance of forklifts used in the warehouse, safety precaution to be taken during the operation of forklift under load.
Dispensary ProcedureThis procedure is mainly concerned with dispensing plans and instructions of released raw materials for production use. An example of tablet dispensary procedure is prepared for better explanation and understandings of dispensing. You will be able to follow the instruction for dispensing of any raw materials in your facility.
Material Purchasing Information RecordThis simple procedure describes how to keep purchasing information for approved materials, vendors, manufacturers, standard and current pricing and third party agreements.
Generation of Purchase OrderThis procedure describes the steps to be followed by planning and procurement department to create purchase order for inventory items to be purchased from overseas and local suppliers.
Quality GuidanceValidation of Analytical Test MethodsThis guideline provides guidance for the validation of analytical test methods. These analytical test methods include those tests which evaluate API, Raw Materials, In Process samples (e.g. reaction monitoring) and early intermediate materials (prior to the introduction of the first critical intermediate). This also include Risk Assessment and Prioritization, System Suitability, Precision and Accuracy, Quantitation and Detection Limit Linearity, Range and Specificity, Robustness,
Calculations of Residue Limits for Drug Product for Equipment CleaningThis guideline provides equations and examples for calculating the Maximum Allowable Residue and Residue Acceptability Limits for Drug Products and Non-Therapeutics. Examples are provided for determining the acceptable equipment cleaning residue limits for therapeutic drug products and for non-therapeutic ingredients.
Swab Sampling for API Equipment This guidance provides recommendations related to the selection and application of swab sampling and visual inspection for various types of API equipment.
Product and Equipment Grouping and Worst - Case Product SelectionThis procedure defines the criteria that should be considered when grouping Active Pharmaceutical Ingredient (API) and Drug Product (DP) equipment or product for the purposes of cleaning validation.
Validation of Test Method for Rinsate and Swab Sample
The guidance describes recommended approaches to develop and validate sampling and test methods for cleaning verification using rinse and swab samples.
Visual Inspection and Quantitation in Equipment CleaningVisual inspection is the minimum requirement for all clean and test regimes required for Cleaning and Cleaning Validation. Five aspects of visual inspection discussed in this guidance. Which are visual inspection following or during manual cleaning; visual inspection of dedicated equipment; routine visual inspection of multi-purpose equipment; visual inspection during validation and Visual Quantitation
Documentation and Instruction in Cleaning Validation14 This guidance addresses recommendations for developing and documenting the rationale to support the product contact equipment cleaning program and to justify the validation strategy. This documentation may be described as a Cleaning Evaluation Report.
Critical Process Parameters for Drug ProductThis guidance provides recommendations and examples for evaluating a process to identify and define the critical process parameters.
Identification of the Critical Steps for Drug Manufacturing ProcessThis guidance provides recommendations for selecting critical process parameters and critical process steps based on the understanding of a drug product process.
Equipment Cleaning Validation for APIThis procedure provides guidance in the validation of cleaning processes for equipment used in the manufacture of Active Pharmaceutical Ingredients (API).
Equivalence Criteria of Impurities in API Process Validation This guidance provides recommendations for demonstrating equivalence of impurities to historic batches during validation of API processes for small molecules.
Equivalency Comparison of Drug Product This guidance addresses the equivalency comparison of manufacturing process data from drug product (DP) validation batches to previous batches (called “reference” batches), when applicable.
Calculation of Clean Equipment Hold TimesThis guidance describes considerations and risks for determining if the establishment of clean equipment hold times for equipment producing drug product and Active Pharmaceutical Ingredients (API) are required
Potential Impact of Changes in Process ValidationThis guidance provides recommendations and examples for evaluating the process validation impact of changes to manufacturing processes used for manufacture of API, Drug Products and packaging processes.
Process Validation SamplingThis guidance addresses recommendations for good sampling practices. Validation sampling plans must be specified or referenced in the protocol.
Determination of Swab & Visual Inspection Sampling Locations This guidance provides recommendations related to the selection and application of swab sampling and visual inspection for various types of Drug Product equipment.
Bulk Drug Product Holding TimesThis Guidance sets out guidelines for the determination and validation of in-process and bulk product holding times.
Continuous Quality VerificationThis guidance provides an example of documentation to support the use of Continuous Quality Verification for demonstrating that a manufacturing process is in a validated state.
Dose & Toxicity Data for Cleaning Limit CalculationThis guidance provides points to consider when selecting Dosage and Toxicity data for use in the Cleaning Limits calculations.
Inspection Attributes in Non Sterile Packaging Validation This procedure provides examples and guidance on classification of defects for packaged non-sterile drug products.
Laboratory Instrument QualificationThis procedure provides guidance in the qualification of simple, moderate, and complex laboratory equipment that is used in an analytical laboratory in a Good Manufacturing Practices (GMP) environment associated with products in or intended for the market place.
Matrices and Bracketing in Process ValidationBracketing and matrixing allow a ‘most appropriate challenge’ condition to be defined for a process or drug product family (the same drug product with different dosage strengths). This risk-based approach can allow the validation to be focused on the most challenging circumstances, or “worst cases.” Use of this approach can provide a significant benefit to reduce the overall validation effort.
Potential Critical Process Parameters and Validation Practices This Guidance provides a tabulation of potential critical process parameters and quality attributes of typical steps of primary solid drug product (i.e. dry products) packaging processes. It also includes packaging validation items such as evaluation of equipment, protocol and report contents, amount of data (e.g. number of runs) and if warranted, microbiological studies.
Process Validation Sampling for Non-Sterile Liquid Semi Solid Drug ProductsThis guidance provides Process Validation Sampling guidelines for non-sterile liquid (solutions and suspensions) and semi-solid (ointments, creams, pastes, gels and lotions) drug product dosage forms.
Process Validation Sampling for Non-Sterile Solid Dose Drug ProductsThis guidance provides Process Validation Sampling guidelines for non-sterile solid dose drug product dosage forms. The purpose of this guidance is to provide the general principles and approaches that should be considered for sampling non-sterile solid dosage forms.
Periodic Review of Processes and SystemsThis guidance addresses the application of a risk-based approach to: Prioritize the systems and processes for periodic review (PR); Justify frequency and schedule of PR (if applicable); Routine revalidation of processes.
Selection of Critical Process Parameters for ValidationThis guidance discusses the term critical process parameter and considerations are described for identifying the term CPP that need validation. It is applicable to the manufacture of commercial intermediates, API, Drug Products and packaging.
Solvent Recovery Validation ExampleThis guidance provides an example of the documentation for validation of a solvent recovery process. Solvent recovery validation is needed in some situations such as where the recovered solvent is intended for general site wide reuse into suitable manufacturing processes, including other API manufacturing processes than those from which the used solvent originated
Test Deviations during ValidationOut-of-specification (OOS) results and any other deviations that may impact the acceptability of the qualification/validation should be documented, investigated, root cause determined, corrective action taken and reported. Several examples are included.
Validation DocumentationThis guidance provides recommendations for the content of the planning, testing and reporting types of validation documentation.
Product Quality Complaint HandlingThis Complaint Handling guidance defines practices for establishing and maintaining a product quality complaint handling system, and for monitoring and reporting corrective actions based on the findings
Application of Quality Risk Management to Periodic Review of SOPsApplication of Quality Risk Management to Periodic Review of SOPs is intended to provide a tool for determining the optimal review frequency that will ensure those SOPs which relate to GMP systems or processes and therefore bear the greatest potential for impact on product quality are reviewed/revised in a timely and possibly more frequent manner than those which are determined to be less critical or reflect stable processes.
Statistical Rationale for Raw Material SamplingThe practice of using the √N+1 as a rule for sample size is common in the pharmaceutical industry.
Structured On-the-Job Training SystemThis document discusses considerations for a site Structured On-the-Job Training system including GMP tasks and knowledge necessary to perform those tasks.
Quality Assurance AuditThis document provides guidance in the conduct of Quality Assurance Audits to verify and assure the effectiveness of on-going quality systems, practices and programs and to identify potential procedural gaps or system weaknesses at Manufacturing Production and logistic Sites.
Annual Product Records ReviewThis document provides guidance in the performance of annual product record reviews to evaluate data and trending to: Verify consistency of the process; Identify the need to modify specifications, and Identify any preventive or corrective actions that would lead to product quality improvements.
Material Supplier ApprovalThis document provides guidance in the process for identifying suppliers to be audited and the process for conducting and documenting such audits and approving suppliers.
Storage & Distribution of Drug Products and Medical DevicesThis document provides guidance the storage and distribution requirements for Drug Products, Medical Devices and related Production Materials from a GMP Site or Logistics Centers, and/or transported between manufacturing and Logistic Sites.
Pest ControlThis document provides guidance in the implementation and maintenance of pest control program for buildings and facilities at a GMP Site and Logistics Centers that are used for production, testing, or storage of pharmaceutical ingredients.
Water Purification, Storage and Distribution for Pharmaceutical ProductionThis document provides guidance for the purification, storage and distribution of water used for Production including water used for cleaning of product contact equipment, containers, and closures.
Reduced Testing ProgramThis guidance document defines a science and risk-based approach for the evaluation and implementation of a reduced testing program for the release of starting materials, intermediates, APIs, excipients and packaging components at a GMP user site upon receipt from vendors (manufacturer/supplier). The guidance also provides an example of the application of Quality Risk Management principles in the implementation of a reduced testing program.
Stability TestingThis document provides guidance for the stability testing for drug products, consumer non-drug products (e.g., cosmetics), Active Pharmaceutical Ingredients (API), API Intermediates for Sale and medical devices manufactured at GMP facilities.
Implementation of Real Time ReleaseThis document provides practical guidance on how to implement a Real Time Release (RTR) testing approach as part of a manufacturing control strategy to ensure product quality while enabling the rapid release of API, intermediate and/or finished products.
Preventive MaintenanceThis document provides guidance in for Preventive Maintenance of direct impact systems and associated critical components used in production, storage, and testing that may affect the safety, identity, strength, quality, or purity of active pharmaceutical ingredients, drug products, drug product raw materials, API starting materials, critical in-process materials, critical intermediates, biologics, or medical devices.
Analytical Laboratory ManagementThis document provides guidance for the management of analytical laboratories including the following: Personnel training; Proper handling of samples; Hazardous materials; Control and maintenance of reagents, reference standards, and buffers; Laboratory facilities and equipment; and Documentation and control of test results.
Microbiology Laboratory ManagementThis document provides guidance for the management of microbiology laboratories including the following: Proper handling of samples; Control and maintenance of reagents, reference standards, buffers, microbial cultures, and microbiological culture media; Monitoring and control of the microbiology laboratory environment; Calibration and maintenance of laboratory equipment; and Documentation and control of microbiological test results.
Quality AgreementsThis document provides general guidance to site Quality Teams responsible for writing, revision and maintenance of Quality Agreements with suppliers of materials.
Clean Steam SystemsThis document provides guidance for clean steam used in aseptic applications, and applications where the steam or condensate directly contacts products or materials, or direct product contact surfaces (i.e., equipment, containers, closures).
Cleaning and Sterilization of Aseptic Manufacturing EquipmentThis document provides guidance in the cleaning and sterilization of aseptic manufacturing equipment to minimize the risk of particulate and microbiological contamination.
Container Closure Integrity for Sterile Drug ProductsThis document provides guidance for ensuring that the integrity of the container closure system will protect the product over its shelf life.
Controlling the Microbiological Quality of Solid Oral Dosage FormsTo control the microbial quality of a non-sterile Solid Oral Dosage form, it is recommended to perform a risk assessment of the manufacturing process to identify potential sources of microbial
contamination. The intention of this document is to provide guidance to determine and control these sources of microbial contamination.
Evaluation of Repeat Testing and Retesting During Microbiological OOS Investigation During a laboratory investigation, confusion may arise as to the difference between these terms and their overall purpose. This document provides a more detailed explanation of these differences and the individual importance of these tools during a microbiological OOS laboratory investigation. In addition, this guidance will also briefly clarify similarities and differences of these definitions as compared to analytical OOS laboratory investigations.
Microbiological Testing in Cleaning ValidationThis document describes the rationale and recommended microbiological methodology for consideration during cleaning validation of product contact surfaces for Active Pharmaceutical Ingredients (APIs) and drug products.
Overview of Trending of Environmental Monitoring DataThis guidance establishes the need for trending of environmental monitoring data and gives recommendations on aspects of trending such as categorization of data, frequency of trending, trend definition, and content of trend reports.
Cross Contamination PreventionThis document provides guidance for the prevention of cross contamination in production processes, warehousing, material transfer, and distribution.
Water Activity in Pharmaceutical ManufacturingThis document discusses the basic principles of water activity and the importance it has in the manufacture of pharmaceuticals. It also provides direction on when and where testing for water activity can be most beneficial.
Quality Manuals
Retention and Disposal of GMP Documents and Retention SamplesThe purpose of this procedure is to describe the minimum requirements for the retention of samples and documents under GMP and Medical Device regulations/legislation. Local legislative and regulatory requirements which may require retention of increased sample quantities or longer retention periods, take precedence over this procedure.
Certificate of Materials SuppliedThis guideline aims to define the processes for certification of materials provided by suppliers including the requirements for maintaining materials in a “certified“ status for use.
Procedure for Quality Assurance Management for Contractors
The purpose of this Procedure is to describe the requirements for the quality management of contractors; to describe the role of contract giver sites in this context and to provide a model for the development of Quality Assurance Agreements with Contractors
Regulatory Inspection GuidelineTo provide the minimum mandatory requirements for notification, conduct, reporting and follow-up action associated with inspections by regulatory authorities and also to outline recommendations on how to achieve compliance.
Compliance Improvements Plans for GMP FacilityThe purpose of this document is to provide some requirements as well as some recommendations for the development, content and management of Compliance Improvement Plans (CIPs). Archiving, Disposal and Record Management GuidelineThe purpose of this document is to provide management and technical personnel with requirements as well as guidance on the archiving, records management and disposal of data and information.
Audit of a Distribution Site for Medicinal ProductsThis Procedure defines the procedure for performing Distribution Site audits and includes selecting, preparing for, conducting, reporting and documentation archiving of Distribution Site audits.
Supplier Auditing for GMP FacilityThis manual is to provide guidance on assigning Lead Audit Team/Site responsibilities, establishing an external supplier’s audit program, and the high level principles involved inconducting supplier audits.
Management and Control of Master GMP DocumentThe purpose of this Guideline is to provide the regulatory requirements for the management of master GMP documents; issued, controlled and used to verify compliance with required codes of GMP and/or other relevant Quality and Compliance Standards. Recommendations are also included on how to achieve compliance
Artwork Creation & Control of Printed Packaging ComponentsThe purpose of this Guideline is to describe the way in which artworks and printed package components should be created and controlled.
Definition and Documentation of Raw DataThe purpose of this Guideline is to provide requirements in the definition and documentation of raw data and also to outline recommendations on how to achieve compliance.
Risk Management in the Quality Assurance and Compliance Area
The purpose of this document is to give guidance on a process for risk identification, assessment, control and review within the area of GxP regulated quality and compliance.
Guideline for Development and Contents of SpecificationsThe purpose of this guideline is to describe the process for generation, approval and management within R&D of specifications for release of materials used in clinical trials during drug development. It also gives guidance on the contents of such specifications for drug substance, several common types of investigational medicinal products and excipients.
Determination of Storage Periods for APIs, Excipients, Intermediates and Raw MaterialsThe purpose of this Procedure is to define the requirements for the retesting and assignment of storage periods for API’s, excipients, intermediates and raw materials.
The Preparation of Process Validation Master PlanThis procedure covers the planning of validation activities related to the manufacturing and control of the registered stages of Drug Product or Active Pharmaceutical Ingredient (API) for clinical use, validation or sale.
Process Validation of Bulk Medicinal (API and Intermediate)The purpose of this document is to provide guidance on the validation of processes for the manufacture of bulk drug i.e. those synthetic stages from introduction of the defined API Starting Materials into the process up to and including the physical processing of the API (Active Pharmaceutical Ingredient). Validation should extend to those operations determined to be critical to the quality and purity of the API. The validation of stages prior to the API Starting Materials is not mandatory. A risk assessment may deem it necessary.
Process Validation for Formulated ProductsThe purpose of this document is to provide minimum mandatory requirements in the validation of processes for the commercial manufacture of formulated products to demonstrate the effectiveness and reproducibility of a process and being suitable for the intended purpose. The purpose is also to outline recommendation on how to achieve compliance.
Cleaning and Cleaning Validation of API Plant and EquipmentThe purpose of this guideline is: To define the requirements for cleaning plant and equipment used to manufacture active pharmaceutical ingredients (APIs) or their intermediates; To give guidance on how to assure appropriate cleaning of API plants and equipment; To describe when validation is applicable and what must be done to complete validation.
Cleaning and Cleaning Validation For Formulated ProductsThe Purpose of this guideline is to define the minimum requirements for cleaning and validation of cleaning processes for formulated product. It also covers post validation monitoring of the effectiveness of cleaning processes.
Sterilization Process ValidationTo provide guidelines for the validation of sterilization processes used in the manufacturing activities for drug products or active Pharmaceutical ingredients (API) and also to outline recommendations on how to achieve compliance.
Analytical Laboratory Procedure ValidationThe purpose of this guideline is to outline the content and approval process for analytical procedures, and to describe those activities that should be carried out to demonstrate that analytical procedures used in laboratories within R&D and manufacturing operations are suitable for their intended purpose.
Water Quality StandardTo describe the quality standards required for the production, distribution, use and testing of water used in the manufacture of manufactured materials.
Sterility Testing ProcedureThe purpose of this Guideline is to provide a general guideline for sterility testing. This guideline should aid in assuring that the products manufactured at the company’s sites as well as by a contract manufacturers meet the appropriate regulatory and company requirements and that there is a harmonized, company-wide approach to the concept of sterility testing.
Storage and Expiry Dating of Analytical Reagents in LaboratoryThe purpose of this Guideline is to outline the requirements in the expiration dating of all analytical reagents and solutions prepared from these reagents. Recommendations are also included on how to achieve compliance.
Preparation & Maintenance of Stability Protocols and Stability Master PlansThe purpose of this document is to describe the procedure for the preparation and management of Stability Protocols and Stability Master Plans for marketed products and Drug Substances.
Microbiological Testing for Non Sterile Medicinal ProductThe purpose of this Guideline is to provide guidance for the microbiological testing of non-sterile products. This guideline should aid in assuring that the products manufactured at each of the gmp sites as well as by a contract manufacturer should meet the appropriate regulatory and company requirements and that there is a standardized, company-wide approach to the basic concept of microbiological quality control of non-sterile products.
Reference & Retention SamplesThe purpose of this guideline is to describe the requirements for the sampling and storage of reference and retention samples under GMP regulations/legislation. Local regulatory requirements that require the retention of additional samples, increased sample quantities or longer retention periods, take precedence over this guideline.
Commercial Stability Testing For Formulated ProductsThe intent of this procedure is to provide to manufacturing and primary packaging sites the principles of a stability program.
Environmental MonitoringThe purpose of this Guideline is to provide requirements for environmental monitoring. This guideline provides recommendations on how to achieve compliance with the requirements. This guideline will aid in assuring that the commercial and investigational medicinal products manufactured will meet the appropriate regulatory and company requirements.
Trending of Stability DataThe purpose of this international guideline is to outline minimum mandatory requirements as well as recommendations for the identification and reaction to trends found in stability data
Manufacturing DocumentationThis document provides guidelines for the way in which the commercial manufacture and packaging of Active Pharmaceutical Ingredients (API) and formulated drug products should be documented.
Maintenance and Calibration of GMP Critical Items in Manufacturing OperationsThe purpose of this guideline is to define the general requirements and to provide guidance for the calibration and maintenance of instruments, equipment, facilities, utilities/services and systems.
Re-treatment and Blending of API & Formulated ProductThe purpose of this guideline is to provide guidance regarding the reworking, reprocessing or recovery (salvaging) of formulated products, active pharmaceutical ingredients (API’s) and intermediates used in the processing of APIs.
In-Process Testing, Checks and SamplingThe purpose of this International Guideline is to describe the requirements for in-process testing and sampling during manufacture and packing.
Management of Returned GoodsThe purpose of this International Guideline is to describe the principle of handling the quality assessment and recovery of returned goods.
Management of Change in Manufacturing OperationsThe purpose of this procedure is to define the principles for management of change within Operations. This document may applies to the Change Management process, to Regulatory Affairs, CMC and to all cGMP activities performed by an Operation sites. It applies to all facilities, processes, systems and procedures used during manufacture, testing and distribution that may directly or indirectly affect the quality of pharmaceuticals products.
.The Validation of Facilities and SystemsThe purpose of this guideline is to provide requirements for the Validation of Facilities and Systems and to outline recommendations on how to achieve compliance.
Information Technology Infrastructure QualificationThis Guideline provides guidance on the qualification requirements to be applied to the Information Technology infrastructure. The establishment and maintenance of a qualified infrastructure for any regulated company is fundamental to meeting current business and regulatory requirements in respect of systems stability, reliability and security.
Management of Change in Computerized SystemThe purpose of this Guideline is to define and provide guidance on the requirements for managing and documenting changes which take place during the development, implementation or operation of a computerized system, including its supporting operating environment.
Access by Regulatory Authorities and Auditors to Electronic RecordsThe purpose of this Guideline is to advise on the practices to be adopted when wishing or requested, to display or provide copies of electronic records to regulatory authorities, auditors and other similar third parties.
Guidelines for Generating Manufacturing DocumentationsThis document provides guidelines for the way in which the commercial manufacture and packaging of Active Pharmaceutical Ingredients (API) and formulated drug products should be documented.
Electronic Records and Electronic SignaturesThe purpose of this document is to provide an interpretation of FDA 21 CFR Part 11, Electronic Records; Electronic Signatures (ER/ES) and to provide guidance for acceptable practices in the use of electronic records and electronic signatures by any site.
GMP Audit Auditing Principles for GMP AuditApply the auditing techniques referenced in this unit to an actual audit. Understand the reasons for using these techniques, understand and use the auditing components while performing a GMP Audit. Use a range of information tools in support of a GMP Audit. Develop and communicate a complete audit agenda (may also be referred to as audit plan) both to audit team members and the firm/area being audited. Effectively execute an audit agenda, Use generally accepted auditing techniques to conduct the audit. Document and communicate audit findings in a clear, concise report that includes examples of identified deficiencies.
Understanding Worldwide Regulatory RequirementsDetermine the appropriate Worldwide Regulatory GMP requirements for a site or product being audited. Identify which Regulatory Agencies govern specific regions of the world. Use a range of information tools in support of a manufactured product distributed and sold throughout the world. Recognize compliance or non-compliance of Worldwide Regulatory GMP requirements
based upon the country or region audited. Explain what the relationships are among the Worldwide Regulatory GMP agencies.
Personnel & Training System Audit Perform an audit of a personnel and training system. Know and understand which of the worldwide requirements apply to personnel and training. Use a range of information tools, including the contents of this module in support of a personnel and training audit. Recognize compliance or non-compliance of regulations pertaining to personnel training requirements.
Deviation Management System Audit Perform an audit of a deviation management system. Use a range of tools and information, including the contents of this unit to support the audit of a deviation management system. Understand and apply appropriate GMP standards/regulations and In-house standards to an audit of a deviation management system. Recognize compliance or non-compliance of deviation management systems to applicable regulations
Validation System Audit Perform an audit of a validation system (excluding computer systems). Use a range of tools and information, including the contents of this unit to support the audit of a validation system. Understand and apply appropriate GMP standards/regulations to an audit of a validation system. Recognize compliance or non-compliance of a validation system to applicable regulations
Change Management System Audit Perform an audit of a change management system. Use a range of tools and information, including the contents of this unit and the internet to support the audit of a change management system. Understand and apply appropriate GMP standards/regulations to an audit of a change management system. Recognize compliance or non-compliance of a change management system to applicable regulations.
Complaint System Audit Perform an internal, supplier or contractor audit of a complaint system. Know and understand which of the worldwide requirements apply to managing complaints. Use a range of information tools, including the contents of this module and the Internet in support of a complaint audit. Recognize compliance or non-compliance to regulations pertaining to complaints.
Documentation System Audit Perform an audit of a documentation system. Use a range of tools and information, including the contents of this unit to support the audit of a documentation system. Understand and apply appropriate GMP standards/regulations to an audit of a documentation system. Recognize compliance or non-compliance of documentation systems to applicable regulations.
Calibration, Preventative Maintenance & Housekeeping System Audit Perform an audit of a calibration, preventive maintenance and housekeeping system. Use a range of tools and information, including the contents of this unit and the internet to support the audit of a calibration, preventive maintenance and housekeeping system. Understand and apply appropriate GMP standards/regulations to an audit of a calibration, preventive maintenance and
housekeeping system. Recognize compliance or non-compliance of calibration, preventive maintenance and housekeeping systems to applicable regulations.
Computerized Systems Audit Identify computer systems with GMP implications within the scope of the GMP facility audit Include in the audit an assessment of the computerized systems used to support a GMP facility. Understand and apply applicable GMP requirements to the audit. Recognize compliance or non-compliance of GMP facilities to applicable regulations for computerized systems.
Utility Systems Audit Perform an audit of a site utilities system. Use a range of tools and information, including the contents of this unit and the Internet, in support of auditing a utilities system. Understand and apply applicable GMP standards to an audit of a utilities system recognize compliance or non-compliance of a utility system to applicable regulations.
Warehouse and Distribution System Audit Perform an audit of warehousing and distribution. Access and understand warehousing and distribution requirements, including licensing requirements. Use a range of tools and information, including the contents of this module and the Internet, in support of auditing warehousing and distribution. Understand and apply applicable GMP standards/regulations to an audit of warehousing and distribution. Recognize compliance or non-compliance of regulations pertaining to warehousing and distribution requirements.
Environmental Monitoring System Audit Perform an Environmental Monitoring Audit. Use a range of tools and information, including the contents of this unit and the Intranet, to support an Environmental Monitoring Audit. Apply worldwide regulatory agency requirements to Environmental Monitoring. Recognize compliance or non-compliance of regulations regarding Environmental Monitoring requirements.
Microbiology and Sterility Testing Laboratory Audit Understand what the GMP requirements are for microbiological and sterility testing laboratories. Identify which GMP regulations govern microbiological and sterility testing laboratories. Use a range of information tools, from the contents of this training module to the Intranet, in support of microbiological and sterility testing. Recognize compliance or non-compliance of a microbiological and sterility testing laboratories
Analytical Quality & Stability Testing Laboratory Audit Understand what the GMP requirements are for the analytical quality laboratory and stability testing laboratory. Identify which GMP regulations govern the analytical quality laboratory. Use a range of information tools, from the contents of this training in support of analytical testing and stability testing auditing. Recognize compliance or non-compliance of analytical quality laboratory and stability testing.
Material Handling System Audit Perform an audit of a material handling system. Use a range of tools and information, including the contents of this unit to support the audit of a material handling system. Understand and apply appropriate GMP standards/regulations to an audit of a material handling system. Recognize compliance or non-compliance of material handling systems to applicable regulations.
Active API Manufacturer Audit Perform an audit of an API manufacturer. Use a range of tools and information, including the contents of this module and the Internet in support of auditing an API module. Understand and apply applicable GMP standards to an audit of an API manufacturer. Recognize compliance or non-compliance of API manufacturers to applicable regulations.
Packaging Material Supplier AuditPerform a packaging component supplier audit. Understand which worldwide requirements apply to packaging component suppliers. Use a range of information tools, including the contents of this module, in support of a packaging component supplier audit. Recognize compliance or non-compliance with regulations pertaining to packaging component supplier’s requirements.
Packaging and Labeling Operation AuditPerform a packaging and labeling audit. Know and understand which of the worldwide requirements apply to packaging and labeling operations. Use a range of information tools, including the contents of this module to the Intranet, in support of a packaging and labeling audit. Recognize compliance or non-compliance of regulations pertaining to packaging andlabeling requirements.
Aseptic Sterile Area AuditPerform an audit of an aseptic/sterile processing area. Access and understand aseptic/sterile manufacturing requirements. Understand worldwide regulatory agency requirements for aseptic/sterile processing. Use a range of information tools, from the contents of this module to the Intranet in support of an aseptic/sterile processing audit. Recognize compliance or non-compliance of areas to regulations pertaining to aseptic/sterile processing requirements.
Auditing an Excipient SupplierPerform an audit of an excipient vendor. Use a range of tools and information, including the contents of this unit and the Internet, in support of auditing an excipient vendor. Understand and apply applicable GMP standards and site standards to an audit of an excipient vendor. Recognize compliance or non-compliance of excipient vendors to applicable regulations.
Auditing an Oral Solid Solution AreaApply the regulatory requirements related to oral dosage forms. Perform an audit of oral dosage forms. Use a range of information tools, from the contents of this unit to the Intranet in support of an audit of oral dosage forms. Recognize compliance or non-compliance of regulations pertaining to requirements for oral dosage forms.
Quality Templates
Raw Material Specification and Test Report Template, Internal Audit Report Template, Training Report Template, Form Template, SOP Template, Quality Assurance Agreement Template, Third Party Manufacture Dispatch Report Template, In-House Manual Template, Rework Protocol for Manufactured Finished Goods, Vendor Assurance and Audit Report Template, Rework Protocol for Work in Progress Goods, Position Paper Template, Laboratory Control Method Template, Product Formulation Template, Finished Product Specification and Test Report Template, Packaging Material Specification and Test Report, Bill of Materials Template
Validation Templates
Cleaning Validation-Rinsing Test Template, Cleaning Validation-Swab Test Template, Cleaning Validation-Comparative Analysis Template, Example of Installation Qualification Report, Example of Operational Qualification Report, Example of Operational Qualification Test Protocol, Example of Performance Qualification Test Protocol, Example of Validation Plan, Example of Validation Report, Example of User Requirement Specification, Example of Commissioning Plan, Example of Design Qualification Protocol, Example of Installation Qualification Equipment, Example of Installation Qualification HVAC, Example of Installation Qualification Operating Environment, Example of Installation Qualification Pipe-work, Example of Installation Qualification Utilities, Example of Electrical Demand Specification, Example of Instrumentation Demand Specification, Example of Mechanical Demand Specification, Example of HAZOP Report, Example of Traceability Matrix Report, Example of Validation Discrepancy Form, Example of Validation Report Combined OQ_PQ, Example of Project Definition Report, Example of Project Evaluation and Closeout Report, Example of Test Protocol Change Request Form, Example of Installation Qualification Computer, Cleaning Validation Interim Report Template, Cleaning Validation Campaign Length Increase Protocol, Cleaning Validation Protocol Template, Cleaning Validation Report Template, Installation and Operational Qualification Protocol Template, Installation and Operational Qualification Report Template, Packaging Validation Protocol Template, Packaging Validation Report Template, Process Validation Protocol template, Process Validation Report Template, Process Validation Report Template-pdf links, Product Transfer Protocol Template, Electronic Records and Signatures Compliance Assessment, Impact Assessment Template for Equipment, Utility and Computer.
Pharmaceutical GMP Professional Certification
References
Code of Federal Regulations 21CFR (including FDA Preamble [Fed Register Vol. 43 No. 190] ) documents
210-211 Current Good Manufacturing Practice in Manufacture, Processing, Packing, or Holding Finished Pharmaceuticals
Section 7 Recalls (Including Product Corrections) Part 11 Electronic Records ; electronic signatures Part 58 Good Laboratory Practices for Non-clinical Laboratory Studies 1308.11-1308.15 requirement for storage of controlled substances 205 Guidelines for State Licensing of Wholesale Prescription Drug Distributors
Food and Drug Administration (FDA) Guidances
Changes to an Approved NDA or ANDA Container and Closure Integrity Testing in Lieu of Sterility Testing as a Component of the
Stability Protocol for Sterile Products Container Closure Systems for Packaging Human Drugs and Biologics Current Good Manufacturing Practice for Combination Products for the Submission Documentation for Sterilization Process Validation in Applications for
Human and Veterinary Drug Products General Principles of Software Validation Powder Blends and Finished Dosage Units--Stratified In-Process Dosage Unit Sampling and
Assessment Product Recalls, Including Removals and Corrections Q1A (R2) Stability Testing of New Drug Substances and Products Q1E Evaluation of Stability Data Q3B( R) Impurities in New Drug Products Quality Systems Approach to Pharmaceutical CGMP Regulations Sterile Drug Products Produced by Aseptic Processing
FDA Guide to Inspections
Investigations Operations Manual (IOM) 2008 Microbiological Pharmaceutical Quality Control Laboratories Pharmaceutical Quality Control Laboratories Topical Drug Products Validation of Cleaning Processes High Purity Water Systems Biotechnology inspection guide reference materials and training aids
FDA Guidelines
Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs Validation of the Limulus Amebocyte Lysate Test Inspections of Sterile Drug Substance Manufacturers Inspections of Oral Solid Dosage Forms Pre/Post Approval Issues for Development and
Validation
Investigating Out of Specification Test Results General Principles of Process Validation
FDA Policy Guides (Compliance Policy Guides (CPG))
Preapproval Inspections 7346.832 Sterile Drug Process Inspections Program 7356.002A Compliance Program Guidance Manual for FDA Staff: Drug Manufacturing Inspections Program
7356.002 Compliance Program Guidance Manual 7356.002F Active Pharmaceutical Ingredient (API)
Process Inspection
Pharmaceutical Inspection Convention/Co-operation Scheme (PIC/S)
PE 008-2 Explanatory Notes for Industry on the Preparation of a Site Master File PE 010-3 PIC/S Guide to Good Practices for the Preparation of Medicinal Products in Healthcare
Establishments Pl 006-3 Recommendations on Validation Master Plan Installation and Operational Qualification
Non-Sterile Process Validation Cleaning Validation Pl 007-4 Recommendation on the Validation of Aseptic Processes Pl 009-3 Aide-Memoire on Inspection of Utilities Pl 010-3 Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects Pl 011-3 Good Practices for computerized systems in regulated “GXP” environments Pl 012-3 Recommendation on Sterility Testing Pl 014-3 Recommendation on Isolators Used for Aseptic Processing and Sterility Testing
American National Standards Institute (ANSI)/International Organization for Standards (ISO)
ANSI/ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories
ISO 19011:2002 Guidelines for Quality and Environmental Management Systems Auditing ISO 9001-2000 Quality Management Systems Requirement
Directives
Directive 2001/82/EC on the Community Code Relating to Veterinary Medicinal Products Directive 2003/94/EC Laying Down the Principles and Guidelines of Good Manufacturing
Practice in Respect of Medicinal Products for Human and Investigational Medicinal Products for Human Use as amended
Directive 2001/83/EC on the Community Code Relating to human medicinal products
European Good Manufacturing Practice
Eudralex Volume 4, Parts I and II and Annexes
Health Canada Guidelines
0069 Guidelines for Temperature Control of Drug Products During Storage and Transportation Good Manufacturing Practices Guidelines
International Conference on Harmonization (ICH) Documents
ICH Q10 Harmonized Tripartite Guideline--Pharmaceutical Quality System ICH Q7 Good Manufacturing Guide for Active Pharmaceutical Ingredients ICH Q9 Quality Risk Management ICH Q10 Pharmaceutical Quality System ICH Q2A Text on Validation of Analytical Procedures ICH Q2B Validation of Analytical Procedures: Methodology ICH Q3A Impurities in New Drug Substances ICH Q3C Impurities: Guideline for Residual Solvents ICH Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and
New Drug Products: Chemical Substances ICH Q8 Pharmaceutical Development
International Society for Pharmaceutical Engineering (ISPE) Guidelines
ISPE GAMP IV and V (Good Automated Manufacturing Practice) Guide for Validation of Automated Systems
U.S. Drug Enforcement Agency (DEA)
21 USC Sec. 812: L.91-513 Controlled substances act
Parenteral Drug Association (PDA) Technical Reports
Report No. 1 Validation of Steam Sterilization Cycles
Japan
Pharmaceutical Administration, Regulation and Drug Development in Japan
European Pharmacopeia
2.2.44 Total Organic Carbon in Water for Pharmaceutical Use 2.2.46 Chromatographic Separation Techniques 2.6.7 Mycoplasmas
Australian Guidelines
TGA Guidelines for Sterility Testing of Therapeutic Goods TGA Amended EU (EMEA/410/01) Guideline Note for Guidance on Minimizing the Risk of
Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products
United States Pharmacopeia (USP)
General chapters related to pharmaceutical analytical methods and practices
World Health Organization (WHO) documents
Good Manufacturing Practices (A Compendium of Guidelines and Related Materials Volume 2: Good Manufacturing Practices and Inspection)
QAS/04.068/Rev. 2 Good Distribution Practices for Pharmaceutical Products Quality Assurance of Pharmaceuticals: A Compendium of Guidelines and Related Materials,
2004 WHO
FDA Center for Biologics Evaluation & Research (CBER) Guidances
Bioanalytical Method Validation Biological Indicator (BI) Premarket Notification [510(k)] Submissions Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other
than Blood and Blood Components Characterization and Qualification of Cell Substrates and Other Biological Starting Mat’ls Used
in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases Points to Consider (PTC) in the Characterization of Cell Lines Used to Produce Biologicals Q5A Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or
Animal Origin Q5E Comparability of Biotechnological/Biological Product Subject to Changes in their
Manufacturing Process
9CFR and 21CFR documents (related to biologics)
9 CFR Parts related to Animal Biologics Quality Requirements in Manufacturing 21 CFR 601 Licensing 21 CFR 600 Biological Products: General 21 CFR 610 selected sections critical to biologic drugs
Compliance Policy Guides (CPGs)
CPG 7345.848 Inspection of Biological Drug Products Guide to Inspections of Lyophilization of Parenterals
