Services Book 2016 - 2016 party audit (TPA) - GMP services ... Audit Report Supporting data release check-list (post-audit annexure data) ... Pharmacovigilance Services

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  • Services Book2016

  • Pharmathen | Services | 2

    PhilosophyWe embrace research and science, providing innovative products and integrated services to improve peoples quality of life.

    Our DNA

    Vision We aspire to be one of the best healthcare companies in the world, providing leading pharmaceutical innovations and solutions, sustaining our impressive growth rates and securing customer preference.

    MissionWe strive to make a difference in peoples lives though leading innovation in medicine and research driven activities. We are firmly committed to continually excel in developing, manufacturing and commercializing advanced pharmaceutical products and services, made effectively and affordably available.

  • Pharmathen | Services | 3

    Contents

    Company Profile

    Third Party Auditing

    Regulatory Affairs

    Drug Safety & Pharmacovigilance

    Scientific Operations

    Intellectual Property

    Quality Management & Assurance

    Quality Control

    5

    6

    10

    14

    22

    26

    28

    30

  • 4Pharmathen | Services |

    We deliver high quality

    products and solutions

    with return to our

    customers and society

  • Pharmathen | Services | 5

    Pharmathen, located in Athens, Greece, was founded in1969 as a private pharmaceutical company, and is focused on developing and marketing innovative health care products, with a strong position in generics. With a long history of development and manufacturing of pharmaceutical products, Pharmathen has emerged as one of the largest development companies in Europe.

    Today, the in-house development products of Pharmathen are registered in all major EU markets and licensed out to the largest pharmaceutical companies in Europe, Canada, Australia, South Africa and the United States. In addition, Pharmathen is able to provide a complete backwardly integrated service to its clients, from the synthesis of the API, to the formulation and finally to the production of the finished product.

    Furthermore, Pharmathen through its accumulated experience and know-how, is now able to provide, apart from products and advance technological solutions, various independent services to its partners, which are vital to the pharmaceutical industry worldwide.

    In this booklet you will find detailed descriptions, as well as therelevant contacts for these services, which include: Medical & Pharmacovigilance, Third Party Auditing, Regulatory Affairs, Quality Management & Quality Assurance, Quality Control, Intellectual Property, and Scientific Operations.

    Company Profile

  • Pharmathen | Services | 6

    Third party Auditing Services

    Contacts:

    For details and inquiries, please contact our Head of International Audits & Compliance via

    e-mail (madhu@pharmathen.com) or by phoning 0091-98401-71659 or 0030-6943-298600

    Pharmathen | Services | 6

  • Pharmathen | Services | 7

    Third party audit (TPA) - GMP servicesPharmathen offers professional services of conducting GMP audits, in particular APIs, to support Marketing authorization / Manufacturing license holders to comply with Article 46f of the Directive 2001/83/EC & 2001/82/EC and the rules governing Medicinal Products in the European Union, Volume 4 Guidelines to Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use, Part II (formerly Annex-18), Basic requirements for Active Substances Used as Starting materials

    The audit program of TPA services is in line with EU directives (Article 46f of 2001/83/EC) of API GMP expectations, commission delegated regulation (EU) No 1252/2014 of supplementing Directive 2001/83/EC & as per European Medicine Agency (EMA) guidance on the use of GMP compliant APIs manufactured in GMP compliant sites verified by the MA holder,;

    EMA/196292/2014, 21 May 2014, Guidance for the template for the qualified persons declaration concerning GMP compliance of active substance manufacture (the QP declaration template);

    European Medicines Agency (EMA) directive dated 21 May 2014 of EMA/334808/2014, Qualified Persons declaration concerning GMP compliance of the active substance manufacture The QP declaration template & EudraLex The Rules Governing Medicinal Products in the European Union Volume 4, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Part 1 Chapter 5: Production : Starting Materials # 5.27 & 5.29.

    Key advantages:

    Pharmathens TPA services help the applicant of a marketing authorization or a manufacturing authorization holder to issue a declaration that the active substance(s) concerned has/have been manufactured in accordance with above directives. Pharmathens TPA services are in line with the EMA (European Medicine Agency) GMP inspection groups aspirations, meaning that the results of an audit conducted by the third party are credible thus waiving the need for an audit conducted by the manufacturing authorization holder itself.

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    Brief synopsis on Pharmathens TPA services:

    The audit program is a comprehensive service beginning with the pre-audit evaluation, followed by the actual conduction of the audit and detailed reporting, until the follow-up of formal audit observation closure/s. It also involves re-audit(s) or compliance audit(s) as and when required, and as per the frequency and requirements of our clients. Our experienced International Audit team is highly qualified and experienced in conducting Audits and reporting, having already conducted more than 1000 audits covering not only APIs, but also extending into finished dosage forms, packaging and laboratory operations, sterile products and starting materials like KSM, advanced intermediates (chemicals) etc. These audits so far have been conducted all across Asia, EU and the US.

    You can feel assured of the services offered as they are based on our fundamental principle, Commitment in dependability and reliability. Please find attached a short presentation that gives a more detailed description and the overview of our services.

    Auditing Program Report StructureAudit Report Format consisting of following key levels & types *

    1) Audit Report AR Main section with 9 attachments2) Attachments (AT-1 to AT-9) on each section described individually, with AT-1 to AT- 8 being systems specific, AT-9 is product specific, AT-10 only for sterile specific)

    Note: By this concept, each product details (narration as well as product specific observations) shall be kept separately as stand-alone such that any customer who is interested in a particular product shall be delivered 2-sets, i.e. 1 with systems specific and 1-product specific, and therefore the integrity of each product information is protected and it is not disclosed. This is giving consideration to the multiple products and different customers encountered and hence not to give unnecessary irrelevant extra info etc.

    3) Audit Report Cross-reference file (pre-audit preparation data) ARC4) Audit Report Supporting data release check-list (post-audit annexure data) ARS5) Audit Report Release check-list (formal release) ARR6) Annexure in support of report additional stand-alone files as listed out in ARS and ARR with previous audit references etc.

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    Total 13 14 main files, supported by several reference & annexure files

    Summary: Overall it is like a Plant Master File with exhaustive information compiled as much as possible to make it a comprehensive package in totality.

    * Audit Report Package and Agreement Templates are available on request

    Synopsis

    InternationalAuditTeamplacedstrategicallyinIndia InlinewiththeEMEAGMPinspectiongroupsaspirationson3rdpartyaudits Expandinghorizonstomeetglobaldemands Committedtobedependable&reliablewithtrustworthinesstopartners

    Track Record

    Combinedauditexperienceofmorethan1000audits Totalhands-onindustrialexperienceof100years AuditsconductedsofaracrossAsia,Europe,MexicoandUS RangeofauditscoverentirePharmaceuticalsupplychain,fromAPItofinisheddosage, to sterile, to packaging, to laboratory Extendedtoclinical(CRO&BA-BE)outsourced

    History

    EstablishedinDecember2007toofferservicetoindustry Continuedrelationshipwithseveralclientssinceestablishment SignedexclusivearrangementwithleadingGenericsCompaniesglobally ExistingclientsfromEU,USandCanadacomprisingofleadingGlobalGenericpharmaceuticalcompanies Clientrequestsincludenewenquiries&repeatinterests

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    Pharmathens Regulatory Affairs has more than 20

    years of experience in regulatory submissions

    worldwide.

  • Regulatory Affairs Services Our primary focus is to use our expertise to ensure we globally provide high quality regulatory affairs advice, from the early concept stage and strategy building, up to and beyond dossier submission and marketing authorisation ensuring that your products are not only marketed by the quickest and most cost effective route, but remain on the market.

    Pharmathen | Services | 11

    Regulatory Services

    Strategicandproductplanning Regulatorysubmission Lifecyclemanagement Regulatorysupport

    Strategic and product planning

    The Pharmathen team, with its extensive experience in Regulatory Affairs and strong scientific backgrounds, understands and can interpret regulatory scenarios for its clients and provides a wide r

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