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Medicines quality assurance: WHO activities in the field of pharmaceuticals. RABAT 29/11/2007 Quality Assurance and Safety: Medicines Department of Medicines Policy and Standards. Main points addressed. WHO role and function WHO standard setting process

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Medicines quality assurance:

WHO activities in the field of pharmaceuticals

RABAT 29/11/2007

Quality Assurance and Safety: Medicines

Department of Medicines Policy and Standards


Main points addressed
Main points addressed

  • WHO role and function

  • WHO standard setting process

  • WHO international guidelines, standards and norms in the area of quality assurance

  • WHO's operational strategies


Who does the work
WHO does the work?

  • 193 Member States

  • Two governing bodies: - World Health Assembly - Executive Board

  • WHO Secretariat: - HQ - six Regional Offices - WHO Expert Panels (e.g... on the International Pharmacopoeia and Pharmaceutical Preparations)


How to become a who expert
How to become a "WHO Expert"?

  • Official nomination process

  • Upon proposal to WHO in consultation with:

    • Member State/national government (citizenship)+

    • WHO Regional Office (in accordance with Member State) +

    • WHO Headquarters

  • Period of maximum 4 years

  • Possibility to renew


  • When does the who expert committee start development of a guideline guidance
    When does the WHO Expert Committee start development of a guideline/guidance?

    • Based on recommendations by :

    • World Health Assembly resolutions(e.g. GMP - Good manufacturing practices)

    • Executive Board resolutions(e.g. delegating certain functions of INN Programme )

    • International Conference of Drug Regulatory Authorities(e.g. ICDRA – Certification Scheme for pharmaceutical starting materials moving into international commerce)

    • Other WHO programmes and clusters (e.g. necessity for quality control specifications for specific medicines of major public health interest)

    • Expert Committee (e.g. revision of general methods included in The International Pharmacopoeia)


    What is the who expert committee
    What is the WHO Expert Committee? guideline/guidance

    • Official Advisory Body to Director-General of WHO

    • Governed through rules and procedures (Ref. WHO Manual)

    • Participation in Expert Committee (EC) meetings:

      • Members ("Expert") selected from WHO Panel of Experts

      • Technical advisers

      • Observers: - international organizations, - NGOs, - professional associations…


    Outcome of the who expert committee
    Outcome of the WHO Expert Committee? guideline/guidance

    • Report of the WHO Expert Committee:

      • Summarizes discussion

      • Gives recommendations to WHO + Member States

      • Includes newly adopted guidelines;

      • Is presented to WHO Governing Bodies for final comments, endorsement and implementation by Member States

    •  constitutes WHO technical guidance


    Examples of who expert committees
    Examples of WHO Expert Committees ? guideline/guidance

    • WHO Expert Committee on Specifications for Pharmaceutical Preparations

    • WHO Expert Committee on the Selection and Use of Essential Medicines

    • WHO Expert Committee on Drug Dependence

    • WHO Expert Committee on Biological Standardization

    • Joint FAO/WHO Expert Committee on Food Additives

    • ….


    Scope of who expert committee on specifications for pharmaceutical preparations
    Scope of WHO Expert Committee guideline/guidanceon Specifications for Pharmaceutical Preparations

    • Production

    • Quality Control

    • Quality related regulatory guidelines

    • Inspection

    • Distribution

    •  from manufacture to delivery to patient


    How does the who consultation process work
    How does the WHO consultation process work? guideline/guidance

    • Step 1. Preliminary consultation and drafting

    • Step 2. Draft guidelines

    • Step 3. Circulation for comments

    • Step 4. Revision procedure

    • .......... (back to step 2 and 3 as often as needed)

    •  WHO Expert Committee (EC) meeting

      • if guideline adopted, published in EC report as Annex

    • -> WHO Governing bodies

    • -> Recommendation to Member States for implementation


    Guidelines adopted by 40 th who expert committee 1 held end october 2005
    Guidelines adopted by 40 guideline/guidanceth WHO Expert Committee (1) held end October 2005

    • 1.List of available International Chemical Reference Substances (ICRS) - update

    • 2. Good manufacturing practices: supplementary guidelines for heating, ventilation and air-conditioning (HVAC) systems

    • 3. Good manufacturing practices: supplementary guidelines on GMP for the manufacture of herbal medicines


    Guidelines adopted by 40 th who expert committee 2 held end october 2005
    Guidelines adopted by 40 guideline/guidanceth WHO Expert Committee (2) held end October 2005

    • 4. Good manufacturing practices: supplementary guidelines for Validation

    • 5. Good distribution practices (GDP) for pharmaceutical products

    • 6. Model Quality Assurance System for Procurement Agencies


    Guidelines adopted by 40 th who expert committee 3 held end october 2005
    Guidelines adopted by 40 guideline/guidanceth WHO Expert Committee (3) held end October 2005

    • 7. Guidelines on registration requirements to establish interchangeability of multisource (generic) pharmaceutical products

    • 8. Proposal to waive in vivo bioequivalence requirements for the WHO model List of Essential Medicines (immediate release, solid dosage forms)

    • 9. Guidelines for organizations performing in vivo bioequivalence studies


    Guidelines adopted in 41 st who expert committee october 2006
    Guidelines adopted in 41 guideline/guidancest WHO Expert Committee (October 2006)

    • 1. The International Pharmacopoeia. Related substances tests: dosage form monographs

    • 2. General guidelines for the establishment, maintenance and distribution of chemical reference substances

    • 3. Procedure for assessing the acceptability, in principle, of pharmaceutical products for purchase by United Nations agencies (update)

    • 4. Procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies (update)

    • 5. Guidance on introduction of variations to a prequalified product dossier


    Advantages of who s expert committee standard setting process
    Advantages of WHO's Expert Committee standard-setting process

    • 1. Guidelines and specifications validated internationally, through an independent scientific process

    • 2. Collaboration with standard-setting organizations and parties, including regional and national pharmacopoeias

    • 3. Close collaboration with WHO Member States, Drug Regulatory Authorities, national medicines quality control laboratories


    Advantages of who s expert committee standard setting process 2
    Advantages of WHO's Expert Committee standard-setting process (2)

    • 4. Links with other WHO activities

    • 5. Input from manufacturers (including international research associations and generic associations) from around the world

    • 6. Consideration of costs, e.g. keeping need for reference standards at a minimum

    • 7. Service FREE FOR USE by all Member States


    Implementation by
    Implementation by process (2)..

    • All dealing with medicines

    • International, regional bodies and organizations, procurement agencies (e.g. UN Prequalification Project for medicines and quality control laboratories, UNICEF)

    • Country related projects: implementation by national regulatory authorities, national quality control laboratories


    Who partners
    WHO Partners process (2)

    • National and regional authorities

    • International organizations (UNAIDS, UNICEF, World Bank, etc)

    • International professional and other associations, NGOs (including consumer associations, industry)

    • WHO Experts

    • Specialists from all areas, regulatory, university, industry………

    • WHO Collaborating Centres (official nomination process)

    • Pharmacopoeia Commissions and Secretariats, national institutions and institutes ..

    • Regional and inter-regional groups (ICH…)


    Quality assurance in who historical overview
    Quality Assurance in WHO process (2) Historical overview

    • 1874 Discussion on Unification of terminology and composition of drugs

    • 1902 First Conference organized by Belgian Government

    • 1906 Agreement on Unification of the Formulae of Potent Drugs ratified by 19 states

    • 1925 Brussels agreement (signed 1929)

    • League of Nations: “international pharmacopoeia”


    Quality assurance in who historical overview 2
    Quality Assurance in WHO process (2) Historical overview - 2 -

    • 1937 First meeting (experts from B, DK, F, NL, CH, UK, USA) - League of Nations

    • 1947 Interim Commission of WHO takes up health related work of League of Nations

    • 1948 First World Health Assembly established Expert Committee on Unification of Pharmacopoeia


    Manufacturing past and present
    Manufacturing: past and present… process (2)

    • Past:

      • Manufacture direct from API -> finished product

      • Manufacture of API in sites close to or same as product

      • Experience and long-standing knowledge of production, product and manufacture of parties involved

      • Few intermediates in sales chain

      • Usually stable trade and sales connections


    Manufacturing past and present1
    Manufacturing: past and present process (2)…

    • Present:

      • Contracting-out of many steps in manufacture

      • Many intermediates in trade and sales chain

      • Trade, shipping, long distances involved

      • Increase of risks…

      • More requirements and documentation

      • More national control mechanisms


    Global challenges
    Global challenges process (2) …

    • National vs international requirements

    • Number of requirements

    • Application and interpretation of requirements

    • Import vs export control on national level

    • Quality assurance systems applied

    • Knowledge of product by parties involved in manufacture

    • Cross-border promotion and sale

    • Free trade zones


    Global challenges1
    Global challenges… process (2)

    • Number of national and international inspections by same party

    • Number of inspections in same site by different parties

    • Applicability of new technologies in different

    • Contracts, agreements, eg Mutual Recognition Agreements

    • Risks of mistakes, accidents, human errors etc

    • Counterfeit drugs

    • …...


    Who s global guidelines and strategies
    WHO’s global guidelines and strategies process (2)

    • Requirements for drug registration and model legislation

    • Collaboration with regulatory authorities

    • International alerts

    • Counterfeit network

    • Global norms and standards and nomenclature (INN) …..


    INNs process (2)


    Who s global guidelines quality control
    WHO’s global guidelines - quality control - process (2)

    • International specifications (Int.Ph., screening tests..)

    • WHO Model Certificate of Analysis (COA)

    • Quality control laboratories:

      • Good practices for national control labs

      • List of equipment

      • External Quality assessment scheme for labs


    International pharmacopoeia
    International Pharmacopoeia process (2)

    • current: 4th edition! Supplement 1 in preparation

    • implementation: “ready for use” by Member States

    • Scope since 1975:

      • Model List of Essential Medicines and

      • Drugs recommended by WHO Specific disease programmes, e.g. Malaria, TB, HIV/AIDS


    Who s strategy for quality control
    WHO’s strategy for quality control process (2)

    • Step-wise approach:

      • - Basic tests (identification)

      • - Screening tests (TLC)

      • - The International Pharmacopoeia

      • - International chemical reference standards (ICRS)

      • - IR reference spectra


    External quality assessment scheme for national drug quality control laboratories
    External Quality Assessment Scheme for National Drug Quality Control Laboratories

    • Capacity building

    • Third phase

    • Series of 5 tests

    • 42 participating laboratories, including WHO Collaborating Centres

    • In all 6 WHO regions


    External quality assessment scheme for national drug quality control laboratories1
    External Quality Assessment Scheme for National Drug Quality Control Laboratories

    • Phase 4 (06/2007 - 01/2009)

      - 50 laboratories invited to participate.

      - Studies:

      • Titration

      • Water content by Karl-Fischer

      • Dissolution test

      • Determination of glucose by polarimetry

      • HPLC assay


    Participation in external quality assurance scheme link with pq programme
    Participation in External Quality Assurance Scheme -> link with PQ Programme

    • Phase 3 (07/2004 - 06/2006)

      • 11 of QC laboratories involved in prequalification procedure participated

        • Algeria, South Africa CENQAM, South Africa RIIP

        • Ghana, Kenya, Mali, Niger, Senegal, Tanzania, Uganda, Zimbabwe

      • 2 other African QC laboratories took part

        • Morocco, Tunisia

    • Phase 4 (06/2007 - 01/2009)

      • All 15 QC laboratories involved in prequalification procedure invited


    Who s global guidelines production
    WHO’s global guidelines - production with PQ Programme

    • Good Manufacturing Practices (GMP) …..

    • 1. Main principles for pharmaceutical products

      • requirement for the sampling of starting materials (amendment)

      • water for pharmaceutical use

      • heating, ventilation and air-conditioning (HVAC) systems

      • Validation

    • 2. … for starting materials, including

      • active pharmaceutical ingredients

      • pharmaceutical excipients


    Who s global guidelines production 2
    WHO’s global guidelines - production (2) with PQ Programme

    • 3. … for specific pharmaceutical products:

      • Sterile pharmaceutical products

      • Biological products

      • Investigational pharmaceutical products for clinical trials in humans

      • Herbal medicines

      • Radiopharmaceuticals


    Who s global guidelines inspection
    WHO’s global guidelines - inspection with PQ Programme

    • Inspection of…..

      • pharmaceutical manufacturers

      • drug distribution channels (products)

    • Guidelines for pre-approval inspection

    • Quality systems requirements for national GMP inspectorates

    • Model GMP certificate

    • Model report for inspections


    Who stability guidelines
    WHO stability guidelines with PQ Programme

    • Title: “guidelines for stability testing of pharmaceutical products containing well established drug substances in conventional dosage forms”currently under revision !

    • ->stability testing of final drug products

    • -> well established (e.g. generics)

    • -> in conventional dosage forms (e.g. tablets)

    • --> close collaboration with

      ICH group Q1, ASEAN and regional harmonization groups


    Who stability guidelines second draft what s new
    WHO Stability guidelines second draft What's new? with PQ Programme

    • Scope covers:

      active pharmaceutical ingredients + pharmaceutical products

    • Marketed + new

    • Transition period recommended for already marketed actives and products


    Who stability guidelines second draft what s new ctd
    WHO Stability guidelines second draft What's new? – ctd - with PQ Programme

    • Cross-reference to other guidelines, e.g. ICH text on photostability

    • List of WHO Member States' required long-term stability conditions as per info received from countries, concept of classification of countries according to climatic zones abandoned

      -> preference to provide "real" conditions required by national authorities


    Who s operational strategies
    WHO’s operational strategies with PQ Programme

    • Assist Member States to strengthen or establish national drug regulation (upon request)

    • Study alternative ways of improving control and safe trade of starting materials and products

    • Promote cooperation and harmonization among countries (e.g. ICDRA)

    • Collaborate with regional and inter-regional regulatory harmonization efforts (in all 6 WHO regions)


    Who s operational strategies 2
    WHO’s operational strategies -2- with PQ Programme

    • Work with interested parties and countries to combat counterfeit and substandard drugs

    • Assistance in establishing and evaluation of national and regional quality control laboratories

    • Training of drug regulatory staff (e.g. in registration of HIV/AIDS medicines)

    • Development of “how to” manuals

    • Responding to national and international requests in area of quality assurance for medicines (e.g. for Global Fund)


    As health professionals, in public and private sector, as an international community

    ...we have a lot left to do

    …all of us, together, things that do matter,

    in right time and in right order!


    WHO Medicines Quality Assurance website: international communityhttp://www.who.int/medicines/areas/quality_safety/quality_assurance


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