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Management representative Q.A.Incharge Managing Director Prepared by Checked by Approved by TITLE: Site Master File Document No. EFFECTIVE DATE NEXT REVIEW DATE PAGE No. SMF/01/01 01.10.2009 30.09.2010 1 of 35 SITE MASTER FILE OF SOLITAIRE PHARMACIA PVT.LTD. PLOT NO.25 Ext -1 HPSIDC AREA BADDI DISTT SOLAN HIMACHAL PRADESH-173205 Dosage Forms : Tablets (General & Hormonal )

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Page 1: Smf Update SOLITAIRE

Management representative Q.A.Incharge Managing DirectorPrepared by Checked by Approved by

TITLE: Site Master FileDocument No. EFFECTIVE DATE NEXT REVIEW DATE PAGE No.

SMF/01/01 01.10.2009 30.09.2010 1 of 35

SITE MASTER FILE

OF

SOLITAIRE PHARMACIA PVT.LTD.

PLOT NO.25 Ext -1 HPSIDC AREA BADDI DISTT SOLAN HIMACHAL PRADESH-173205

Dosage Forms : Tablets (General & Hormonal )

Page 2: Smf Update SOLITAIRE

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TITLE: IndexDocument No. EFFECTIVE DATE NEXT REVIEW DATE PAGE No.

SMF/01/01 01.10.2009 30.09.2010 2 of 35

Sr.No Title Page No.1 Cover Page 012 Index 023 General Detail 034 Plant Location 04&05

5 General Information 06&07

6 Process Approach 08&09

7 Personal 10 To 12

8 Premises 13 To 15

9 Ventilation system & Utilities 16 To 19

10 Equipments 20 To 25

11 Sanitation & Documentation 26 & 27

12 Production 28 & 29

13 Quality Control 30 To 32

14 Distribution, Complaints and Product Recall 33

15 Self Inspection 34

16 Quality policy 35

REVISION INDEX

Sr. No.

Date Document No.

Change Details CheckedBy

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TITLE: General DetailDocument No. EFFECTIVE DATE NEXT REVIEW DATE PAGE No.

SMF/01/01 01.10.2009 30.09.2010 3 of 35

General Detail

3.1 Type of Industries : Pharmaceuticals Industry.

3.2 Name of Dosage Forms : General Tablet, Hormonal Tablet

3.3 Works (Factory) : SSoolliittaaiirree PPhhaarrmmaacciiaa PPvvtt..LLttddPlot No. 25 Ext-1 HPSIDC Area,Baddi, Tehsil Nalagarh , Dist solan.(H.P) -173 205.Tel.: 09815777744E-mail : [email protected]

: [email protected]

3.4 Marketing Office : SSoolliittaaiirree PPhhaarrmmaacciiaa PPvvtt..LLttdd PLOT NO. 73,INDUSTRIAL AREA,

PHASE II, CHANDIGARH.

Tel.: 0172-5000477,5000478Fax:5000477,2653293

3.5 Contact Persons : Mr. Sanjeev Kumar Sethi (Managing Director)

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TITLE: Site Location Plan

Document No. EFFECTIVE DATE NEXT REVIEW DATE PAGE No.SMF/01/01 01.10.2009 30.09.2010 4 of 35

AM

Annexure:4.1ARA

Road No. 3 VAT

Plot no.19

SOLITAIREPHARMACIA

PVT. LTD. Plot no. I Plot no.25

Plot no26. Plot no.

Plot no 27

RPlot no. O

Plot no.18 AD

Plot no.28 Plot no.

Plot no.29 Plot no.

Road Road Road

Spray Eng.

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NALAGARH

TITLE: Site Location PlanDocument No. EFFECTIVE DATE NEXT REVIEW DATE PAGE No.

SMF/01/01 01.10.2009 30.09.2010 5 of 35

DRAW SCATCH OF PLANT LOCATION FROM RAILWAY STATION

Annexure:4.2

PINJOR

CH

A N

DIG

AR

H

KALKA RAILWAY STATION

SolitairePharmacia Pvt. Ltd.

SHIM

LA

BADDIBADDI BUS STOP

AmaravatiAppt. N.R.I

Hospital

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TITLE: General InformationDocument No. EFFECTIVE DATE NEXT REVIEW DATE PAGE No.

SMF/01/01 01.10.2009 30.09.2010 6 of 35

5.0 GENERAL INFORMATION

INTRODUCTION:SOLITAIRE PHARMACIA PVT LTD., a Baddi (H.P.) based company established by Mr.Sanjeev Kumar Sethi, who has deep knowledge and vast experience of pharmaceutical business .He has now ventured in setting up state of the art pharma manufacturing facility of WHO,cGMP standards.

LOCATION :-

The plant is located at Baddi (Himachal Pradesh) in well connected industrial belt at a distance of 40 kms from Chandigarh on Pinjore – Nalagarh Highway and is engaged in the manufacturing of solid dosage forms. The location is well connected with roads & railway station is about 20 kms at Kalka. The plant is located on 997 square meter plot. The factory is constructed and designed to meet the WHO, cGMP standards in consultation with highly qualified and experienced technical personnel’s approved by FDA for manufacturing and testing. The plant has AHU systems i.e., Air conditioning and Control humidity for all manufacturing departments to avoid cross contamination.SSoolliittaaiirree PPhhaarrmmaacciiaa PPvvtt.. LLttdd has established a modern facility as per GMP standards to

manufacture tablets (Non ß-Lactam) & Hormonal tablets . The unit is managed by experienced

technical staff for production & quality control along with a team of expert technicians.

The company has a pharmaceutical formulation plant located on the Ground floor for hormonal

product & first floor for Non ß-Lactam respectively

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SALIENT FEATURES

SOLITAIRE PHARMACIA PVT LTD. has observed and will practice the following:-Factory designed and constructed as per GMP specification.Code of ethics in production and quality.Training to the personnel as per new guidelines.Electrification is done for easy energy audit.Illumination level 300 lux in all manufacturing areas.Water proofing of entire terrace slab.HPLC. UV-spectrophotometer under one roof.Pre-Construction Anti-Termite Pest Control treatment for entire factory building

The company has full fledged Quality Assurance, Purchase, Store, Production, Administration

Engineering Dept., headed by very experienced personnel’s.

All standard operating procedure (work instruction) related with above production process are available with QA department & individual department.Facilities & list of equipment are available in site master file.

List of Proposed products and other technical details are available in site master file.

Plant is fully equipped with:

5.1 Exhaustive pest control system to ensure total freedom from insects and rodents.5.2 Wall, floor and ceiling painted, free from crack, dust and dirt.5.3 Full Fledged water system i.e.(a) Raw water system equipped with sand filter to ensure free from Insoluble and gaseous impurities (b) R.O water plant for Purified water

Core team of HOD’s of Quality assurance/Quality Control, Engineering, Production & Adm. Working under Managing Director ensures effective quality system, planning and Implementation.

TITLE: General InformationDocument No. EFFECTIVE DATE NEXT REVIEW DATE PAGE No.

SMF/01/01 01.10.2009 30.09.2010 7 of 35

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TYPE OF PRODUCTS LICENSED FOR MANUFACTURE WITH FLOWCHART MENTIONING PROCEDURE AND PROCESS FLOW :(i) SSoollttaaiirree PPhhaarrmmaacciiaa PPvvtt..LLttdd manufactures wide range of pharmaceuticals formulations in

General Categories of General Tablet & Hormonal tablets as per the approved Product List enclosed

(ii) For process flow & procedure flow chart as per following. Tablets

Q.A.-2 Q.A-1

Q.A. - 4

Q.A.-3

Q.A.- 4

Sampling --- TestingQA1 --- Water content, Bulk density

Q.A.- 5 QA2 --- Weight variation, Appearance, ColourShape, D.T, Hardness, Friability

QA3 --- D.T. AppearanceQA4 --- D.T, Appearance, Pathogen andQA5 --- In process labeling, packing details

Annexure:6.1

TITLE: Process ApproachDocument No. EFFECTIVE DATE NEXT REVIEW DATE PAGE No.

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Tablet packingCoating

Visual Inspection Compression Lubrication Sizing / Milling

Final ReleaseVisual Inspection

Weighting Sieving Mixing Wet or dryGranulation

Drying

Dispatch

Final Release

Tablet packing

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SSoolliittaaiirree PPhhaarrmmaacciiaa PPvvtt..LLttdd has facility to carry out Chemical Physico-chemical, Instrumental AnalysisSSoolliittaaiirree PPhhaarrmmaacciiaa PPvvtt..LLttdd takes assistance from outside institution for testing its samplesSamples are sent for getting testing done where sophisticated instruments like IR, GC & Bio-Assay are required.

. PROCESS APPROACH: there will be basically four type of process in the organizationa. Core process (customer related process)b. Management process (process carried out by top management /MR)c. Supporting process (process to help core /management process)d. Work process (process flow as per individual department wise

Annexure:6.1

TITLE: Process ApproachDocument No. EFFECTIVE DATE NEXT REVIEW DATE PAGE No.

SMF/01/01 01.10.2009 30.09.2010 9 of 35

Management Process

Quality Policy & Quality Objective(Business Plan)

Budgeting (Resource Plan)

Resource Allotment

Management Review / Audit

Core Process

Marketing

Customer Order

Customer Satisfaction

Production / Service

Planning

Dispatch

Production

Material / Production / Service / testing

Material service procurement /

storage

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TITLE: PersonnelDocument No. EFFECTIVE DATE NEXT REVIEW DATE PAGE No.

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7.0 PERSONNEL

(a) ORGANISATIONAL CHART SHOWING THE ARRANGEMENTS FOR QUALITY ASSURANCE INCLUDING

PRODUCTION & QUALITY CONTROL :

HIERACHICAL CHARTManaging Director

Plant Head

Q.C In Charge Q.A In Charge / Management Representative

Production In Charge

Engineering In Charge

Store In Charge

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TITLE: PersonnelDocument No. EFFECTIVE DATE NEXT REVIEW DATE PAGE No.

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(b) QUALIFICATION, EXPERIENCE & RESPONSIBILITIES OF KEY PERSONNEL :

Sr.No.

Name of Person Qualification Experience Department Approval / Unapproved

(A) MANUFACTURING SECTION1 Mr. Rajesh

MakanwalB.Pharm 8 yrs Mfg. Section Approved

2 Mr Ram lal Prajapati

B.Sc. 18 yrs Mfg. Section Approved

(B) QUALITY CONTROL SECTION3 Mrs. Jahanvi Rao M.Sc. 16 yrs Chemical and

Physicochemical Section

Approved

Number of employees to be engaged in production, quality control, storage and distribution.

Production Dept. : 10Quality control & Assurance Dept. : 06Store ( RM, PM & FG) : 04P & A Dept. : 03Maintenance Dept. : 03Account Dept. : 02Total : 28

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(c) OUTLINE FOR ARRANGEMENT FOR BASIC AND IN SERVICE TRAINING AND HOW RECORDS ARE MAINTAINED :

All employees will have to go through training as per annual training plan. Training on GMP will beon-going process and all the employees will be regularly trained to increase their awareness of current requirements. Immediate outside experts & superior impart through training for all departmental. The employees are subjected to oral & written quarries. The training records will bemaintained for all employees.

(d) HEALTH REQUIREMENT FOR PERSONNEL ENGAGED IN PRODUCTION : Administrative head is responsible for arranging the medical checking of employees

through a qualified physician. Medical examination is carried out by company approved physician every year or in

between if required. For any unusual findings during the check up physician advises the person affected.

During the treatment period suitable reallocation of job is done. Rechecking is done following approved guidance & frequently, and after the person is certified medically fit, he is put on his original job.

(e) PERSONNEL HYGINE REQUIRMENTS, INCLUDING CLOTHING : The company provides change rooms for changing company uniforms including shoes. The employees working in production area change their shoes and wear factory

footwear, along with factory uniforms & cap. The employees in other areas like Quality control will wear aprons and laboratory

slippers. The employees in engineering department wear suitable shoes and factory uniforms.

All the employees have been instructed about dress code and to change the dress every other day.

Other aspects of personnel’s hygiene like daily bath, hair & nail cut.

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TITLE: PremisesDocument No. EFFECTIVE DATE NEXT REVIEW DATE PAGE No.

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8.0 PREMISES

(a) LAYOUT PLAN OR DESCRIPTION OF MANUFACUTRING AREA :

Sr.No.

Area Type of area finishing

1. Ground floor RCC Roof, Kota Stone & Flush doors.2. First floor RCC Roof, Kota Stone & Flush doors.3 Second floor Vetrified tiles in Q.C Area4 Service Area RCC roofs & Covered with fancy hood3. Utility Block RCC Floor 4. D.G.Set Area RCC Floor

Ground floor First floor Second floorSr.No.

Area Sr.No.

Area Sr.No.

Area

1. MD & Adm. Office 1. GeneralProduction 1. Incubator2. Warehouse 2. General Packing 2. Chemical section3. Change room 3. Approved R.M Store 3. Retain sample4. Toilet 4. Approved P.M Store 4. Record room5. R.M.Store 5. Stability chamber6 HormonalProduction 6. Q.C.Office7 Security office 7. Micro testing8 Visitors Rooms 8. Media prepn Room9 Hormonal Packing 9. Instrument Room10 Utility Block11 D.G & Pannel Area

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Canteen & toilet is not directly attached with production area. Plant layout design & equipment is as per the revised schedule-M requirement.

(b) NATURE OF CONSTRUCTION & FIXTURES / FITTINGS : Building: The building is made up of RCC construction and all the processing areas

from inside are having smooth wall painted with oil paint/oil bound emulsion paint. Utility: Manufacturing equipments are provided power supply back up with DG set,

which is bale to restore DG power within 2 minutes. The critical QC instruments are also provided with stabilizer.

Aluminum doors & Windows: The doors and windows are designed very carefully to have a minimum number of horizontal surfaces. The sills of the windows are sloping. The windows are kept flush with the plaster inside manufacturing areas and gap between aluminum and masonry are sealed with scaling.

Floor: Flooring is made up of mirror polished Kota stone. Coving: Coving is provided in all production areas at the junction of wall to floor, wall to

wall to ceiling and are painted with washable paint. Fall ceiling: Fall ceiling in the air-conditioned areas is of plaster of paris sheets. The

sheets is fixed with double layered arrangement and the joints of the upper layer and lower layer of the board are so arranged (staggered) that there is no leakages of air.

All entrances and major doors are provided with air lock and air curtains wherever required.

The sanitary fittings are connected and drainage system is under ground and provided with trapped gullies.

S.S Light S.S-304 riser Both Side Stair & Well Equipped Lift provision

TITLE: PremisesDocument No. EFFECTIVE DATE NEXT REVIEW DATE PAGE No.

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(d) SPECIFIAL AREAS FOR THE HANDLING OF HIGHLY TOXIC, HAZARDOUS & SENSITIZING MATERIALS:

Not Applicable, as presently we do not use such type of materials.

(e) BRIEF DESCRIPTION OF WATER SYSTEMS (schematic drawings of systems) :

Copy attached

Total 4 sampling points are provided for water system monitoring, cleaning, sanitation and validation plan is followed as per standard operating procedures, water log book & water validation file.

(f) DESCRIPTION OF PLANNED PREVENTIVE MAINTAINANCE PROGRAMMES FOR PREMISES AND OF THE RECORDING SYSTEM :

More emphasis is given on the preventive maintenance program of plant utility services, machines etc. Maintenance department is equipped with highly qualified and experienced engineers and technicians. Maintenance as well as plant operators are provided through training at machine manufacturing site for knowing its operation, use, accuracy, efficacy etc.

Installation qualification & performance qualification of every new machine is carried out. Calibrations are done frequently. The logbooks are maintained for all critical equipments.

Whenever necessary, help of outside maintenance consultants is taken to maintain facilities such as Air handling units, laminar air flow, pest control etc. routines as well as periodical maintenance are scheduled and documented. For recording system computer validation system is followed.

TITLE: PremisesDocument No. EFFECTIVE DATE NEXT REVIEW DATE PAGE No.

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TITLE:VENTILATION SYSTEM & UTILITIES Document No. EFFECTIVE DATE NEXT REVIEW DATE PAGE No.

SMF/01/01 01.10.2009 30.09.2010 16 of 35

SR. NO. DESCRIPTION

1 AIR HANDLING UNITS

HOREMON-Ground Floor

AHU-1-4000CFM-65mm- 8TR[Grenulation]

AHU-2-600CFM-65mm- 1.5 TR[Sampling/Dispensing]

AHU-3-600CFM-65mm- 1.5 TR[TIB]

AHU-4-1200CFM-65mm-3TR[Blister Pack]

AHU-5-800CFM-65mm-2TR[Strip Pack]

AHU-6-800CFM-65mm-2TR[Compression]

AHU-7-1200CFM-65mm- 3TR[Coating]

AHU-8-3200CFM-65mm- 6TR[Corridor & Misc.]

AHU-9-600CFM-65mm-1.5TR[Sampling]

AHU-10-800CFM-65mm- 2TR[Blending]

AHU-11-600CFM-65mm- 1.5TR[Sampling]

General Tablets-First Floor

AHU-12-4800CFM-65mm-10TR[Granulation]

AHU-13-1200CFM-65mm-3TR[Blending]

AHU-14-1200CFM-65mm- 3TR[Coating-1]

AHU-15-1200CFM-65mm- 3TR[Compression-1]

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AHU-16-800CFM-65mm- 2TR[Compression-2]

AHU-17-600CFM-65mm- 1.5TR [TIB]

AHU-18-600CFM-65mm- 1.5TR[Dispensing]

AHU-19-1200CFM-65mm-3TR[Blister-1]

AHU-20-1200CFM-65mm-3TR[Blister-2]

AHU-21-800CFM-65mm- 2TR[Strip Packing]

AHU-22-3200CFM-65mm-6TR[Corridor & Misc.]

AHU-23-1200CFM-65mm- 3TR[Coating-2]

Quality Control-Second Floor

AHU-24-600CFM-65mm-1.5TR[ Micro Q.C.]

2 Forcd Draft Ventillation Supply Air System[GROUND FLOOR]

FDVS-1:2000-20[Gen.Ch.Room]

FDVS-2:1000-50[Hormon Ch.Room]

FDVS-3:1000-20[Hormon PMS]

FDVS-4:1000-20[General PMS]

FDVS-5:3000-20[Misc. Q.C.Area]

3 Forcd Draft Ventillation Exhaust Air System[GROUND FLOOR]

FDVE-1:1000-20[Gen.Ch.Room-First floor]

[Not Require as Room Exhaust-Hormon]

FDVE-3:1000-20[Hormon PMS]

FDVE-4:1000-20[General PMS]

[Not Require as Room Exhaust-Q.C]

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4 Refrigeration Type Dehumidifire

1 TR

2 TR

OTHER UTILITIES[GROUND FLOOR]

5 Air Compressor-1

Air Compressor-2

6 Compressed Air Dryer

7 D.M Water Plant

8 D.M Water Plant

9 ETP

Split A.C Misc. Stores[GROUND FLOOR]

R.M.Approved Store

Horemone F.P.S

Secondary Packing Hall

General FP Stores

Director's Office

Reception

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Manager Office

Staff Office

Split RM Stores[FIRST FLOOR]

A.C Approved RM[14a]

ALU.PVC Store[14b]

Split A.C Misc. Areas[SECOND FLOOR]

Q.C.Manager

Critical Instrument Room

General Instrument Room

Retain Sample Room

Minimum 20 air changes are provided in all production area, supply filter are having 5 porosity & return filter are having 20 porosity. Minimum 0.5mm pressure difference is kept in different categories of production area with maximum positive pressure kept in filling & sealing area. Refer plan layout Annexure 1 for more details.

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TITLE: EquipmentDocument No. EFFECTIVE DATE NEXT REVIEW DATE PAGE No.

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4.0 EQUIPMENT

(a) BRIEF DESCRIPTION OF MAJOR EQIPMENT USED IN PRODUCTION & CONTROL LABORATORIES :

General Tablets

NAME OF MACHINE

SUPPLIER CAPACITY ELE. LOAD H.P

AIR

QTY(CFM) PRESSURE(KG)

FLUID BED DRIER

TECHX 60 KG 14.0 100 6.0 kg

VIBRO SIFTER TECHX 36” 1.0R.M.G TECHX 150 LTR 28.0 10 6.0 kgPASTE KETTLE TECHX 100 LTR 5.0MULTIMILL TECHX 250 KG/HR 3.0LUBRICATIONOCTAGONAL BLENDER

TECHX 300 LTR 3.0

COATING-1COATING PAN TECHX 36” 7.0SOLUTION PREPARATION TANK

TECHX 50 LTR 0.7

COLLOID MILL TECHX 3.0COATING-2COATING PAN TECHX 36” 7.0COMPRESSIONACRA-B4-27-D FLUIDPACK 27 STN (D –

TOOLING)5 .0

ACRA-B4-27-D FLUIDPACK 27 STN (D –TOOLING)

5 .0

DUST EXTRACTOR-1

FLUIDPACK 150 CFM 1.50 150

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DUST EXTRACTOT-2

FLUIDPACK 150 CFM 1.50 150

DE-BURRING&DEDUSTING UNIT 4 NO.

F.P MACHINERIES

2.0

PACKINGBLISTER KULBINDRA 9.0 150 6.0 kgALU-ALU P.G 9.0 150 5.0 kgCONVEYOR BELT-1

1.0

CONVEYOR BELT-2

1.0

HORMONAL SECTIONGRANULATION SECTIONFLUID BED DRIER

TECHX 10 KG 8.0

VIBRO SIFTER TECHX 12” 0.5R.M.G TECHX 25 LTR 5.0MULTIMILL TECHX 2.0LUBRICATIONOCTAGONAL BLENDER

TECHX 50 LTR 1.5

COATING-1COATING PAN TECHX 24” 5.0SOLUTION PREPARATION TANK

TECHX 50 LTR 0.7

COMPRESSIONACRA-B4-27-D FLUIDPACK 27 STN (D

–TOOLING

5.0

DE-BURRING&DEDUSTING UNIT 4 NO.

F.P MACHINERIES

1.0

DUST EXTRACTOR-1

FLUIDPACK 150 CFM

PACKINGBLISTER KULBINDRA 8.80 150 4.0 kgSTRIP KULBINDRA 3.5CONVEYOR BELT-1

1.0

CONVEYOR BELT-2

1.0

D.G. SET SUDHIR GENSET 200 KVA

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AIR COMPRESSOR

KAILA ENGIN 10.0

AIR DRIER KAILA ENGIN 2.0R.O.PLANT ARYATECH 1000

LTR/HR7.0

E.T.P PLANT MAINSA ENGG. WORKS

3000-5000 LTR

7.0

A.H.U DYNAFLOW 250.0

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TITLE: EquipmentDocument No. EFFECTIVE DATE NEXT REVIEW DATE PAGE No.

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SR.NO. NAME MAKE MODEL NO, SPECIFICATION1 HPLC Waters 515 Isocratic system2 UV spectrophotometer Shimadzu UV-1800 Std.3 Analytical Balance4 pH meter5 Abbe refractometer6 Polarimeter7 KF apparatus8 UV cabinet9 Melting point apparatus(digital)

10 Potentiometer/Autotitrator

CHEMICAL SECTION

SR.NO.NAME OF LABORATORY

INSTR. MAKE MODEL NO, SPECIFICATION1 Vaccum oven2 Sonicator3 Mechanical flak shaker4 Water bath5 Universal oven6 Muffle furnace7 Heating mantle8 Hot plate with stirrer

9Dist. Water app. (wall mounted)s.s

10 TLC kit11 Bulk density appa.(Tapping type)12 Dissolution test appa. 8 baskets13 Leak test appa.

14Friability appa.(digital rpm counter)

15 Hardness tester16 IR moisture balance17 Centrifuge machine18 Vortex mixer

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SR.NO.NAME OF LABORATORY

INSTR. MAKE MODEL NO, SPECIFICATION1 Microscope2 Autoclave3 Bacteriological incubator 4 BOD incubator5 Colony counter(digital)

6 Laminar Air Flow bench Popular Horizontal

(b) DESCRIPTION OF PLANNED PREVENTIVE MAINTAINANCE PROGRAMS FOR EQUIPMENT & OF THE RECORDING SYSTEM :

As mentioned in point planned preventive maintenance exists and the records are maintained for preventive maintenance and major breakdown of equipment and machine.

(c) QUALIFICATION & CALIBRATION INCLUDING THE RECORDING SYSTEM AND ARRANGEMENT FOR COMPUTERIZED SYSTEMS VALIDATION :

Periodic calibration / validation of equipments / process / Utilities / system / personnel are carried out and records are maintained. For certain equipments and utilities validation is carried out periodically by the standard external agencies. Calibration / validation schedule protocol is as per calibration / validation Index .It is audited in self-inspection.

Written standard operating procedures are laid for cleaning of manufacturing areas and equipments. For area cleaning two type disinfectants are used fortnightly alternatively. Review of standard operating procedure is made at every three years and any correction / deviation is properly recorded after getting authorization from Q.A. as per procedure of document & data control.

Pest control of the entire plant is maintained through administration department with the help of outside agencies.

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TITLE: EquipmentDocument No. EFFECTIVE DATE NEXT REVIEW DATE PAGE No.

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List of Calibration of Equipments / Instruments

Sr.No. Item Frequency of Calibration/Validation

1 Pest Control Yearly2 Medical Checkup of Employee Yearly3 Aseptic Filling (Media Fill test) Yearly4 Filter Integrity Testing Batch wise5 Manufacturing tank At the time of purchase6 pH Meter Daily7 Single Pan Balance Daily/ Yearly8 Plate form Balance Daily/ Yearly9 Spectrophotometer Monthly

10 Auto clave Daily/Quarterly11 Dry heat sterilizer Daily/Quarterly12 Aseptic Area Daily13 U.V. Light Quarterly14 Thermometer At the time of use15 Glass equipment At the time of purchase16 Normality Testing At the time of use17 Pressure/Temp.gauges/Hygrometer Yearly18 Hepa filters Yearly19 Product Stability studies As per individual product20 Inter Department Audit Quarterly21 Melting point Apparatus Monthly22 Karl Fischer apparatus At the time of use

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TITLE: Sanitation / DocumentationDocument No. EFFECTIVE DATE NEXT REVIEW DATE PAGE No.

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11.0 SANITATION

(a) AVAILABILITY OF WRITTEN SPECIFICATION & PROCEDURE FOR CLEANING MANUFACTURING AREA & EQUIPMENT :

Sanitation of entire plant, surrounding and manufacturing area is being done as per area cleaning SOP’sEfficacy of Disinfectant solutions is validated microbiologically.HVAC system & water system is also continuously sanitized and the same is recorded in utility logbook.Validation of the equipment cleaning will be done as per master validation plan.

11.A DOCUMENTATION

(a) ARRANGEMENT FOR THE PREPARATION, REVISION & DISTRIBUTION OF

NECESSARY DOCUMENTATION FOR MANUFACTURE:

a. Well-defined system exists for in warding, storage and issue of raw & packing materials.

b. Raw & packing materials are sampled and approved by Quality Control department.c. Batch manufacturing records (BMR) for every product and every batch is issued by

quality assurance to production department.d. In process checks at regular intervals are carried out with proper documentation by Q.A.e. All manufacturing operation is followed as per instructions given in BMR and entail

heads before submission to Q.A. for final approval of the batch.f. Before final dispatch of every batch, Quality assurance department verifies BMR along

with certificate of analysis and release slip is issued. Solitaire Pharmacia Pvt. Ltd. maintains documents regarding: Standard Operating Procedure & its related records. Site Master file Specification of all Materials & Finish products Test procedure & protocol Master formula card Batch production & control records Disposal records Release records & distribution records Calibration / Validation records

Quality management system related documents

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Standard operating procedure are prepared for each and every operation and are authorized for all the departmental activities and strictly followed.

All minor changes in the documents are recorded in the same records by recalling copies from all departments for authorization by QA head with date of correction. For major changes entire documents are replaced with amendment copy and old copies are destroyed except one kept with QA department with cancellation.

A detail of documents withdrawal / distribution will be kept with QA department under document and data control index.

Necessary document related to manufacturing such as Master formula card and Batch manufacturing & its associated record are maintained and issued by Q.A.department.

(b) ANY COPY OTHER DOCUMENTS RELATED TO PRODUCT QUALITY THAT IS NOT MENTIONED ELSEWHERE : (E.G. MICROBIOLOGICAL CONTROLS IN AIR & WATER)

Following methods are followed as per well-defined schedule:

Microbial counts and limit tests for bore well, DM water and finished products. Manufacturing, filing & sealing areas environmental monitoring by setting plat count.

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7.0 PRODUCTION(a) BRIEF DESCRIPTION OF PRODUCTION OPERATIONS :

Production operation is explained by way of flow chart describing movement of material & movement of batch manufacturing record. Refer Annexure 6.1 attached.

(b) ARRANGEMENTS FOR THE HANDLING OF STARTING OF STARTING MATERIALS, PACKAGING MATERIALS & BULK & FINISHED PRODUCTS INCLUDING

SAMPLING, QUARANTINE, RELEASE & STORAGE :

Each consignment of material received is examined visually and damaged goods are kept separate and inform to quality control person for further instructions for disposal or return goods to party.

On verification of quantity received and making batch wise segregation identification number is given serially.

All the containers are labeled “UNDER TEST” with details such as name, inward number, quantity, no. of containers, manufacture’s name, material code no. and put material in to the quarantine area.

Samples are drawn as per sampling plan & tested in detail as per specification by quality control. On completion of tests Q.C. decided whether the material is approved or rejected and accordingly if material is approved, “APPROVED” label are fixed and material is transferred to approve material storage area. If material rejected than transfer to rejected area (Flow chart of Movement of material is enclosed).

All packing materials are stored securely under lock & key and issued in requisite number only. At various places of operation separate areas are created so that the material or product is held on “Under Test”, “Approved”, “Rejected” or “Quarantine” area etc. All raw materials are transported in closed labeled containers or properly labeled sealed plastic bags. The Quality Assurance instructions are followed for material status. All weighing balance are regularly calibrated.

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(c) ARRANGEMENTS FOR THE HANDLING OF REJECTED MATERIALS & PRODUCTS :

For all rejected materials, the materials are separated from other “Approved” or “Under Test” lots and “Rejected” labels are affixed by the Quality control persons. The rejected material is transferred to a separate “Rejected materials” area. Quality assurance decides the fate of such rejected materials as to destroy, reprocess or to refer to the supplier.

(d) BRIEF DESCRIPTION OF GENERAL POLICY FOR PROCESS VALIDATION :

Process validation is as per documented program (master validation plan), which provides a high degree of assurance that a specific process will consistently produce a product meeting it’s predetermined specification and quality attributes.

We follow the following systems with regard to process validation:

Establish specification and performance criteria. Select methodology, process & equipment to ensure the product meets with the

specification. Test the final product using validated analytical methods in order to meet specification.

Following steps supports the above steps:

Calibration, verification and maintenance of process equipments. Qualification of both process & equipment. Challenge, audit, monitor or sample the recognized critical or key steps in the process. And finally when there is a significant change in the product or process,

Re-qualify or revalidate the process.

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SHORT DESCRIPTION OF THE QUALITY MANAGEMENT SYSTEM OF THE FIRM

The company believes in total quality management system and constantly upgrading standards of specification of its products & services. The quality policy states as under,

We at Solitaire Pharmacia Pvt Ltd are Committed,

To supply Quality medicines at competitive rates & Service to Satisfy our Customer.

To follow prevailing National & International Standards of Pharmaceutical Industry.

To continually improve our Quality Management System with Continual Training & Collective Wisdom.

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Quality has been the most prime consideration in recruitment of manpower. Our organization chart explains the hierarchical levels of the organization.For strengthening the system, following activities are carried out by Pharma consultants.

The in-house training programme covers all relevant aspects of cGMP. Testing as per well defined specification control the input materials and release

procedures for semi finished and finished products exit. Production as well as Quality assurance monitors quality by carrying out in process testing during various stages of manufacturing.

Standard operating procedures are available for different operations. Products are manufactured as per procedure given in batch manufacturing records and recorded accordingly.

Standard validation/calibration protocols adhered for validation of all critical equipments processes/instruments/products/system/utilities etc.

Master formula records, which are prepared for individual products, are adhered in batch manufacturing & testing processes.

Maintenance history records are maintained for critical instruments and equipments to ensure proper preventive maintenance.

The assessment of effectiveness of QMS is done by periodic self-inspection & management review meeting.a. Incoming material Qualityb. Product Qualityc. Compliance with systems / document controld. Customer complaintse. Corrective action to avoid non-conformityf. Internal Quality Audits

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QUALITY CONTROL(a) DESCRIPTION OF QUALITY CONTROL SYSTEM AND OF THE ACTIVITES OF THE

QUALITY CONTROL / QUALITY ASSURANCE DEPARTMENT PROCEDURE FOR THE RELEASE OF THE FINISHED PRODUCTS :

Quality assurance & Quality control department combines activities performed are as follows. Specification of raw material, Packing material & Finished products are prepared,

standardized & pharmacopoeia guidelines are followed for the same. Outside help is procured for developing in-house specification in area where pharmacopiea specifications do not exist.

Methods for reagent standardization and instrument calibration / validation are defined and being followed.

Procedure for the release of raw material and finished products are defined and being followed as per the standard procedure and the norms down in pharmacopiea or by developing in-house specification.

Company is having well-equipped Quality control laboratory having Physico-chemical instrumentation and microbial testing. Laboratory facilities with necessary retain sample and documentation storage area. All well define procedures for finished product analysis are followed and finished product release for the market after complete testing.

The store dispenses the materials in presence of Q.A. person against bill of materials issued. The dispensed materials carry appropriate labeling.

Manufacturing activities are started as per Batch manufacturing record. In-process checks are carried out by production and Q.A. independently. Coded packing materials are checked by production and Q.A. for the correctness of

batch coding details. The packing department reconciles the printed packing materials. Batch production records are reviewed by production and Q.A. and yield data are

reconciled by production and Q.A. Q.A.department also approves transfer of finished product to finished product store for

sale. Q.A. maintains control samples of raw material and finished products. Stability studies are carried out by Q.A. SOP compliance and GMP implementation is monitored by Q.A.

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10.0 DISTRIBUTION, COMPLAINTS & PRODUCT RECALL

(a) ARRANGEMENTS AND RECORDING SYSTEM FOR DISTRIBUTION :

Finished goods will be transferred from packing department to finished goods stores with transfer note, after getting final release for sale from Q.A. department. For each batch of the final product distribution records are available with dispatch department inside the factory premises

(b) ARRANGMENTS FOR THE HANDLING OF COMPLAINTS AND PRODUCT RECALLS :

On receipt of quality complaints from the customer, Informed to Q.A. department for the same Q.A. department will recheck retain samples and records for the same. Q.A. will send investigation report to customer through M.D. In case of critical complaints decision for recalling the product will be taken by top management and is communicated to distribution manger. Distribution manager will recall the products as per product recall SOP.

Suggestion / complain register for all complaints / suggestions of external / internal origin will be maintained & same is reviewed in management review meeting.

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11.0 SELF INSPECTION

(a) SHORT DESCRIPTION OF SELF-INSPECTION SYSTEM :The self inspection system is based on the Standard Operating Procedure on cGMP requirements covering the following items.

a. Personnelb. Premises including personnel facilitiesc. Maintenance of building & equipmentsd. Storage of starting materials 7 finished producte. Equipmentsf. Production & In-process controlsg. Quality controlh. Documentationi. Sanitation & hygienej. Validation & revalidation programk. Calibration of instruments or measurement systems.l. Recall procedures.m. Complaint managementn. Labels controlo. Results of previous self-inspection & corrective steps taken

QA head will appoints a self-inspection team from local staff, who are expert in their own field and with cGMP & if required,outside expert will be retained by us. This self-inspection will be done once in six month with the help of outside expert.

A report will be made after compliance of the self-inspection, which includes,

1. Self-inspection results2. Correction & root cause analysis3. Recommended corrective actions.

The company management evaluates both the self-inspection report and the corrective action as necessary.

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QQUUAALLIITTYY PPOOLLIICCYY

SOLITAIRE PHARMACIA PVT LTD IS COMMITTED TO ACHIEVE

QUALITY STANDARDS USING NATIONAL & INTERNATIONAL

NORMS WITH CONTINUOUS IMPROVEMENT IN PRODUCTS

AND SERVICES FOR ULTIMATE SATISFACTION OF ALL OUR

VALUED CUSTOMERS.

SOLITAIRE PHARMACIA PVT LTD IS “DEDICATED TO LIFE” AND

QUALITY IS A WAY OF LIFE AT SOLITAIRE PHARMACIA PVT LTD

MANAGING DIRECTOR

( Sanjeev Kumar Sethi )