Introduction to Dossier Requirements and Guidelines within the
Download
1 / 21

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


  • 278 Views
  • Uploaded on

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

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'Introduction to Dossier Requirements and Guidelines within the Prequalification Project quality part' - allayna


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
Slide1 l.jpg

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]


Some abbreviations used in all presentations l.jpg
Some abbreviations used in all presentations the

APIActive pharmaceutical ingredient

BP British Pharmacopoeia

CEP EU certificate of suitability

CPP WHO-type Certificate of a Pharmaceutical Product

EOI Expression of interest

FDC Fixed-dose combination

FPP Finished pharmaceutical product

ICH International Conference onHarmonization

Int.Ph.International Pharmacopoeia

IR Infrared

Ph.Eur.European Pharmacopoeia

SmPC Summary of product characteristics

TB Tuberculosis

USP United States Pharmacopeia

XRPD X-ray powder diffractogram


Prequalification website http mednet3 who int prequal l.jpg
Prequalification website thehttp://mednet3.who.int/prequal/


Pq website menu l.jpg
PQ Website – menu the

Bio group

GMP group

publication on QC testing Jan 06


Pq website product dossiers l.jpg
PQ Website – product dossiers the

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


Pq website menu6 l.jpg
PQ Website – menu the

Bio group

GMP group

publication on QC testing Jan 06


Guidelines for submission from web l.jpg
Guidelines for submission the (from web)

1

2


Guideline main fpps not approved by ich associated dra l.jpg
Guideline (“Main”) theFPPs 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)


Multisource products blue book l.jpg
Multisource products: Blue Book the

  • 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


Main guideline administrative 1 50 l.jpg
Main guideline theAdministrative 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


Main guideline dossier requirements main sections l.jpg
Main Guideline theDossier 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)


Main guideline annexes l.jpg
Main guideline theAnnexes

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


Main guideline supplements l.jpg
Main guideline: theSupplements

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)


Main guideline supplements14 l.jpg
Main guideline: theSupplements

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)


Guideline fpps approved by ich associated dras l.jpg
Guideline theFPPs 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


Pq website menu16 l.jpg
PQ Website – menu the

Bio group

GMP group

publication on QC testing Jan 06


Guidelines fdcs fixed dose combinations fdcs l.jpg
Guidelines: FDCs theFixed-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”)


Ich guidelines l.jpg
ICH guidelines the

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)


Prequalification project variation guideline l.jpg
Prequalification project theVariation 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


Prequalification project variation guideline 2 l.jpg
Prequalification project theVariation 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


Closing remarks l.jpg
Closing remarks the

  • 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


ad