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Medicines quality assurance: WHO activities in the field of pharmaceuticals

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

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  1. 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

  2. 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

  3. 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)

  4. 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

  5. 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)

  6. What is the WHO Expert Committee? • 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…

  7. Outcome of the WHO Expert Committee? • 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

  8. Examples of WHO Expert Committees ? • 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 • ….

  9. Scope of WHO Expert Committee on Specifications for Pharmaceutical Preparations • Production • Quality Control • Quality related regulatory guidelines • Inspection • Distribution •  from manufacture to delivery to patient

  10. How does the WHO consultation process work? • 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

  11. Guidelines adopted by 40th 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

  12. Guidelines adopted by 40th 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

  13. Guidelines adopted by 40th 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

  14. Guidelines adopted in 41st 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

  15. 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

  16. 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

  17. Implementation by .. • 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

  18. WHO Partners • 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…)

  19. Quality Assurance in WHO 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”

  20. Quality Assurance in WHO 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

  21. Manufacturing: past and present… • 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

  22. Manufacturing: past and present… • 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

  23. Global challenges … • 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

  24. Global challenges… • 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 • …...

  25. WHO’s global guidelines and strategies • Requirements for drug registration and model legislation • Collaboration with regulatory authorities • International alerts • Counterfeit network • Global norms and standards and nomenclature (INN) …..

  26. INNs

  27. WHO’s global guidelines - quality control - • 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

  28. International Pharmacopoeia • 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

  29. WHO’s strategy for quality control • Step-wise approach: • - Basic tests (identification) • - Screening tests (TLC) • - The International Pharmacopoeia • - International chemical reference standards (ICRS) • - IR reference spectra

  30. 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

  31. 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

  32. 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

  33. WHO’s global guidelines - production • 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

  34. WHO’s global guidelines - production (2) • 3. … for specific pharmaceutical products: • Sterile pharmaceutical products • Biological products • Investigational pharmaceutical products for clinical trials in humans • Herbal medicines • Radiopharmaceuticals

  35. WHO’s global guidelines - inspection • 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

  36. WHO stability guidelines • 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

  37. WHO Stability guidelines second draft What's new? • Scope covers: active pharmaceutical ingredients + pharmaceutical products • Marketed + new • Transition period recommended for already marketed actives and products

  38. WHO Stability guidelines second draft What's new? – ctd - • 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

  39. WHO’s operational strategies • 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)

  40. WHO’s operational strategies -2- • 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)

  41. 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!

  42. WHO Medicines Quality Assurance website:http://www.who.int/medicines/areas/quality_safety/quality_assurance

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