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Introduction to Dossier Requirements and Guidelines within the Prequalification Project (quality part) PowerPoint PPT Presentation


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Introduction to Dossier Requirements and Guidelines within the Prequalification Project (quality part). World Health Organization Training Workshop on Pharmaceutical Quality, GMP and Bioequivalence Kiev - Ukraine 3 to 7 October 2005. Theo Dekker, D.Sc., consultant to WHO

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Introduction to Dossier Requirements and Guidelines within the Prequalification Project (quality part)

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Introduction to Dossier Requirements and Guidelines within thePrequalification Project (quality part)

World Health Organization

Training Workshop on Pharmaceutical Quality, GMP and Bioequivalence

Kiev - Ukraine

3 to 7 October 2005

Theo Dekker, D.Sc., consultant to WHO

Research Institute for Industrial Pharmacy

North-West University, Potchefstroom, South Africa

[email protected]


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Some abbreviations used in all presentations

APIActive pharmaceutical ingredient

BPBritish Pharmacopoeia

CEPEU certificate of suitability

CPPWHO-type Certificate of a Pharmaceutical Product

EOIExpression of interest

FDCFixed-dose combination

FPPFinished pharmaceutical product

ICHInternational Conference onHarmonization

Int.Ph.International Pharmacopoeia

IRInfrared

Ph.Eur.European Pharmacopoeia

SmPCSummary of product characteristics

TBTuberculosis

USPUnited States Pharmacopeia

XRPDX-ray powder diffractogram


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Prequalification website http://mednet3.who.int/prequal/


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PQ Website – menu

Bio group

GMP group

publication on QC testing Jan 06


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PQ Website – product dossiers

Frequently asked questions

  • Which products do we prequalify?

  • What data and information needs to be submitted in a dossier for a generic product?

  • What data and information needs to be submitted in a dossier for an innovator product?

  • What does a manufacturer have to submit to prove efficacy of a multi-source generic product?

  • How often are dossiers assessed?

    Click on question to get to answer


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PQ Website – menu

Bio group

GMP group

publication on QC testing Jan 06


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Guidelines for submission (from web)

1

2


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Guideline (“Main”)FPPs not approved by ICH/associated DRA

Guideline on Submission of Documentationfor Prequalification of Multisource (Generic) Finished Pharmaceutical Products (FPPs)used in the Treatment of HIV/AIDS, Malaria and Tuberculosis (“main guideline”, hand-out)

Based on

Marketing Authorization of Pharmaceutical Products with special Reference to Multisource (Generic) Products: a Manual for a Drug Regulatory Authority(WHO Blue Book, current edition)


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Multisource products: Blue Book

  • Multisource products are pharmaceutically equivalent

  • Pharmaceutically equivalent products

    • Contain the same API(s)

      • in the same amount(s)

      • in the same dosage form

    • Meet similar quality standards

    • Are intended for the same route of administration

  • Multisource products that are therapeutically equivalentare interchangeable


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Main guidelineAdministrative 1/50

A:Covering letter by responsible person

  • Statement: information is true and correct

    B:Application (Productdossier)

  • Four main sections (with subsections)

  • Keep to the sections/subsections as prescribed

  • Sections/subsections should be clearly marked

    • preferably with securely fixed tags

  • Number all pages (essential)

  • Table of contents

    • List sections, subsections – with page numbers


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Main GuidelineDossier requirements – main sections

Section 1

Characteristics of the FPP(3/50)

Section 2

Active Pharmaceutical Ingredients (APIs) (4/50)

Section 3

Finished Pharmaceutical Products (FPPs) (10/50)

Section 4

Interchangeability (Bioequivalence) (25/50)


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Main guidelineAnnexes

Annex 1: Model Certificate of a Pharmaceutical Product

27/50

Annex 2: Model Batch Certificate of a Pharmaceutical Product 31/50

Annex 3: Model Stability Report of Active Pharmaceutical Ingredient (API) 33/50

Annex 4: Model Stability Report of Capsules/Tablets 36/50

Annex 5: Suggested Structure of the Summary of Product Characteristics (SmPC) 40/50

Annex 6: Suggested structure of the Package Information Leaflet (PIL) 43/50

Annex 7: Recommended presentation of bioequivalence trial information 45/50


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Main guideline: Supplements

Supplement 1

Guideline on Submission of Documentation for Prequalification of Multi-source (Generic) Finished Pharmaceutical Products (FPPs) Used in the Treatment of HIV/AIDS, Malaria and Tuberculosis

Dissolution Testing

for use from July 2005 (CPH25)


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Main guideline: Supplements

Supplement 2

Guideline on Submission of Documentation for Prequalification of Multi-source (Generic) Finished Pharmaceutical Products (FPPs) Used in the Treatment of HIV/AIDS, Malaria and Tuberculosis

Extension of the WHO List of Stable(not easily degradable ARV) APIs

(for stability testing)

for use from July 2005 (CPH25)


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GuidelineFPPs approved by ICH & associated DRAs

Guide on Submission of Documentation for Prequalification of Finished Pharmaceutical Products (FPPs) used in the treatment of HIV/AIDS, malaria and tuberculosis and approved by Drug Regulatory Authorities (DRAs) in the International Conference on Harmonization (ICH) region and associated countries, including inter alia the EU, Japan and USA


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PQ Website – menu

Bio group

GMP group

publication on QC testing Jan 06


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Guidelines: FDCsFixed-Dose Combinations (FDCs)

Draft guidelines for registration of fixed-dose combination medicinal products(WHO, 2005)

comprehensive on all aspects of safety, efficacy and quality

Scientific and Technical Principles for Fixed Dose Combination Drug Products for Treatment of HIV/AIDS, Malaria, and Tuberculosis(HHS, UNAIDS, WHO & SADC, 2004)(“Botswana Principles”)


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ICH guidelines

ICH guidelines are used when a quality aspect cannot be (fully) assessed by the WHO guidelines, for instance:

  • Q3A(R). Impurities in new drug substances

  • Q3B(R). Impurities in new drug products

  • Q3C. Impurities: Guideline for residual solvents

  • Q6A. Specifications: Test procedures and acceptance criteria for new drug substances and new drug products: chemical substances (with decision trees)


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Prequalification projectVariation Guideline

To be published soon on PQ website

  • The prequalification process is dynamic, taking into account that changes to the original dossier may become necessary during the lifetime of the product

  • Any changes or variations may involve administrative and/or more substantial changes and are subject to approval within the prequalification program


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Prequalification projectVariation Guideline (2)

  • ANNEX I

    • List of minor changes

      • The conditions which must apply is stipulated

      • The relevant part of the dossier to be resubmitted or updated, with the documentation required, is listed

  • ANNEX II

    • Lists major changes in general

  • ANNEX III

    • Lists types of changes which may require a new application


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Closing remarks

  • The dossier submitted must conform to the requirements set out in the current WHO guidelines, as posted on web

  • The assessment of quality and safety/efficacy data presented is based on the current WHO guidelines

  • ICH guidelines are used when a quality aspect cannot be assessed by the WHO guidelines

  • The quality assessment includes variations orchanges to already prequalified products


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