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Safe quality medicines

Safe quality medicines. Medicines quality assurance: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Sabine Kopp, PhD Quality Assurance and Safety: Medicines Department of Essential Medicines and Pharmaceutical Policies. Main points addressed. Who is WHO?

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Safe quality medicines

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  1. Safe quality medicines

  2. Medicines quality assurance: WHO Expert Committee on Specifications for Pharmaceutical Preparations Sabine Kopp, PhD Quality Assurance and Safety: Medicines Department of Essential Medicines and Pharmaceutical Policies

  3. Main points addressed • Who is WHO? • How does WHO set standards? • Which WHO guidelines, standards and norms exist in the area of quality assurance? • What's new ?

  4. Who is WHO? Governing bodies • World Health Assembly (WHA) Delegations from 193 Member States Meeting yearly in May • Executive Board(EB) Representatives from 34 Member States + Meeting biannually in January and May

  5. Impressions from World Health Assembly • - SSFFC

  6. Impressions from World Health Assembly Floor of the Assembly Dr Margaret Chan, WHO Director-General Mr Bill Gates, Co-chair of the Bill & Melinda Gates Foundation Her Excellency Sheikh Hasina, Prime Minister of Bangladesh Dr Christos Patsalides, President of the Sixty-fourth World Health Assembly and Minister of Health of Cyprus, and Dr Maria Teresa Valenzuela (Chile), Chair of Committee B .

  7. WHO is WHO ?Secretariat and experts • WHO Secretariat: - Headquarters - six Regional Offices and 149 Country offices • Experts: - WHO Expert Panels and Expert Committees - WHO Collaborating Centres - + partners • Constitution signed 1946, in force since 7 April 1948 (World Health Day)

  8. WHO Partners With Regulatory Bodies… • National/Regional regulatory authorities • Regional/Interregional regulatory groups (ASEAN, GCC, ICH, PANDRH...) Within WHO… • WHO disease programmes (Stop TB, Roll-Back Malaria, HIV/AIDS, Tropical Neglected Diseases, programmes on Children, Women's Health…) • Prequalification Programme – A United Nations Programme managed by WHO

  9. WHO Partners (2) With Organizations and Associations… • International organizations (UNAIDS, UNICEF, IAEA, Global Fund, World Bank…) • International professional and other associations, NGOs (incl. industry, consumer associations: IFPMA, IGPA, WSMI, IPEC, FIP, WMA, MSF…) With Standard-setting Bodies, such as … • Pharmacopoeia Commissions and Secretariats (e.g. BritishBrazilian, Chinese, European, Indian, Korean, Japanese, USP, .. )

  10. WHO Partners (3) With "recognized" Experts… • WHO Expert Panel on The International Pharmacopoeia and Pharmaceutical Preparations (official nomination process) • Specialists from all areasfor specific projects (regulatory, university, industry…) With "recognized" Laboratories… • National/Regional Quality control laboratories • WHO Collaborating Centres (official nomination process)

  11. 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

  12. What is the WHO Expert Committee? • Official Advisory Body to Director-General of WHO • Governed though 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…

  13. 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

  14. WHO Expert Committees rules and procedures  WHO Basic Documents • Constitution of WHO • Expert Committees: chapter V, article 18; chapter VIII, articles 38-40 • For normative function - pharmaceuticals: Chapter 2, article 2 (u): " to develop, establish and promote international standards with respect to food, biological, pharmaceutical and similar products;" • Regulations for Expert Advisory Panels and Committees, including, Annex – Rules of Procedure for Expert Committees

  15. 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 • ….

  16. When does the WHO Expert Committee start development of a guideline/guidance? • Based on recommendations by : • World Health Assembly resolutions(e.g. WHA 20.34, GMP - Good manufacturing practices) • Executive Board resolutions(e.g. EB37.R9 delegating certain functions of INN Programme to DG based on advice from Experts) • International Conference of Drug Regulatory Authorities(e.g. 10th +11th ICDRA – FDC guidelines + 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 and feedback from Prequlifcation programme) • Expert Committee (e.g. revision of general methods included in The International Pharmacopoeia)

  17. 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 process • .......... (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

  18. WHO Governing bodies …

  19. Medicines 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. Medicines 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. Medicines Quality Assurance in WHO Historical overview (3) • 1st "WHO Expert Committee on Specifications for Pharmaceutical Preparations" ( ECSPP) meeting held 13-17 October 1947 • Report of 1st ECSPP meeting published in: • Official Records of WHO, No 8, page 54ff, 1947

  22. Quality of medicines remains a problem

  23. Challenges: 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

  24. Challenges: past and present… • Present: • Rationalization of drug production • Contracting-out of many steps in manufacture • Many intermediates in trade and sales chain • Trade, shipping, long distances involved • Increase of risks… • Increase of requirements and documentation • Increase of national control mechanisms

  25. WHO’s global guidelines and strategies • Requirements for drug registration and model legislation • Networking among and with regulatory authorities • International alerts • Global tools to help ensure that patients receive quality safe quality medicines • Global norms and international standards and nomenclature

  26. INNs

  27. WHO’s medicines quality assurance guidelines Cover: • Development • Production • Quality Control • Quality related regulatory guidelines • Inspection • Distribution •  from manufacture (and before) to delivery to patient

  28. Adopted WHO guidance texts and guidelinesin medicines quality assurance (without PhInt) Maintain to keep up to date: • More than 60 CURRENT official WHO guidance texts and guidelines to date, including 15(8 updates + 7 new adopted 2010)

  29. Quality Control http://www.who.int/medicines/areas/quality_safety/quality_assurance/control/ More than 10 guidance documents and guidelines, including • Good laboratory practices + training materials • Guidelines for establishment of chemical reference standards • Model certificate of analysis • International Pharmacopoeia + Basic tests

  30. International PharmacopoeiaPh.Int. • current: 4th edition! Supplement 1 +2 • 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, medicines for children

  31. External Quality Assessment Scheme for National Drug Quality Control Laboratories • Phase 5 (01/2010 - 12/2012) - 60 laboratories participate - Studies: • - Assay by titration • - Water content by Karl-Fischer • - Dissolution test • - Related substances by HPLC • - Related substances by TLC • - Assay by HPLC • - Dissolution test

  32. Distribution http://www.who.int/medicines/areas/quality_safety/quality_assurance/distribution Some 10 guidance documents and guidelines, e.g.: • Certification schemes (CPP and SMACS) • Quality system for Procurement • Good distribution practices for starting materials and finished products • Good storage practices

  33. Production • http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/ Some 20 guidance documents and guidelines, including: • Good Manufacturing Practices (GMP) …..Consisting of more than 10 major "guideline" texts (regularly updated, new texts added as needs are identified) • ….. Training materials (slides, video, GMP text) • Risk analysis (HACCP) – moving to "quality risk management"

  34. 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

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

  36. WHO’s global guidelines - inspection http://www.who.int/medicines/areas/quality_safety/quality_assurance/inspections/en/index.html • 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

  37. Quality related regulatory standards http://www.who.int/medicines/areas/quality_safety/quality_assurance/regulatory_standards/ Some 20 guidance documents and guidelines, including : • Stability testing requirements • Interchangeability of generic medicines • Fixed-dose combination • All prequalification procedures

  38. 46th WHO Expert Committee on Specifications for Pharmaceutical Preparations – outcome - 1- 1. Adopted texts: The International Pharmacopoeia • Medicines for HIV and related conditions: • Ritonavir tablets - Antimalarial medicines • Artesunate • Artenimol - Antituberculosis medicines • Rifampicin • Anti-infectives: • Pyrantel chewable tablets

  39. 46th WHO Expert Committee on Specifications for Pharmaceutical Preparations – outcome -2- - Antituberculosis drugs (ctd) • Ofloxacin tablets • Levofloxacin • Levofloxacin tablets - For anti-infectives: • Amoxicillin oral suspension • Levamisole tablets • Metronidazole oral suspension • Sulfamethoxazole and trimethoprim tablets

  40. 46th WHO Expert Committee on Specifications for Pharmaceutical Preparations – outcome -3- - For other medicines • Medroxyprogesterone injection • Paediatric retinol oral solution For harmonized general texts (based on PDG texts) • Test for sulfated ash • Test for bacterial endotoxins • Test for sterility • Tablet friability • Disintegration test for tablets and capsules

  41. 46th WHO Expert Committee on Specifications for Pharmaceutical Preparations – outcome -4- • Bulk density and tapped density of powders • Test for extractable volume for parenteral preparations • Microbiological examination of non-sterile products: microbial enumeration tests • Microbiological examination of non-sterile products: tests for specified microorganisms • Microbial quality of pharmaceutical preparations • Test for particulate contamination

  42. 46th WHO Expert Committee on Specifications for Pharmaceutical Preparations – outcome -5- • General policy topics and general revision issues for: • Uniformity of content for single-dose preparations • Supplementary information section for the Ph.Int. • The Committee adopted the following new ICRS: • Lumefantrine for system suitability

  43. 46th WHO Expert Committee on Specifications for Pharmaceutical Preparations – outcome -6- 2. Adopted global quality assurance guidelines: • WHO good manufacturing practices: water for pharmaceutical use • Pharmaceutical development of multisource (generic) pharmaceutical products • Guideline on submission of documentation for a multisource (generic) finished pharmaceutical product for the WHO Prequalification Programme: quality part

  44. 46th WHO Expert Committee on Specifications for Pharmaceutical Preparations – outcome -7- • Monograph development for The International Pharmacopoeia • Development of paediatric medicines: points to consider in formulation • Quality requirements of artemisinin as a starting material in the production of antimalarial active pharmaceutical ingredients

  45. In the pipeline - quality assurance for medicines.. • Ph.Int.: Harmonization with PDG general texts – for those evaluated by ICH Q4B, continue • External Quality Assessment Scheme for National Drug Quality Control Laboratories, 5th series, 3rd test in process, 4th in preparation • Guidance on selection of comparator products for equivalence assessment of interchangeable generic products (revision)

  46. In the pipeline.. • Risk analysis based on HACCP towards Quality Risk Management • Guideline on submission of documentation for a multisource (generic) product – quality part – general guidance • Tools and framework for monitoring of market situation • International meeting(s) for world pharmacopoeiae

  47. Advantages of WHO's Expert Committee standard-setting process • 1. Guidelines and specifications validated internationally, through an independent scientific process, adoption by members of WHO Expert Advisory Panels • 2. Collaboration with standard-setting organizations and parties, including regional and national pharmacopoeias • 3. Networking and close collaboration with WHO Member States, Drug Regulatory Authorities, national medicines quality control laboratories

  48. Advantages of WHO's Expert Committee standard-setting process (2) • 4. Links with other WHO activities • 5. Reality check: Input from manufacturers (including international associations of research, generic and self-medication associations) 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

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

  50. Safe quality medicines

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