Quality assurance in the supply chain for pharmaceuticals from the WHO perspective

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2 Quality assurance in the supply chain for pharmaceuticals from the WHO perspective Dr Sabine Kopp Quality Assurance and Safety: Medicines Medicines Policy and Standards World Health Organization

3 Presentation to Pharmacy faculty in Frankfurt 1. Who Is WHO? 2. Is quality a problem? - International and national challenges 3. National Medicines Policy et al. 4. WHO global activities in: - Quality control - Production - Inspection - Distribution 5. WHO operational strategies 3

4 Is quality of medicines a problem? Yes, a HUGE problem "If we would have the same compliance with norms and quality in aircraft industry globally " (Dr Rägo, WHO) "approximately 25% planes would not take off the ground 10% would crash and kill the people (treatment failure = killing in some cases; toxicity etc. )" 4

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7 Labels not stuck properly 7

8 Loose powder in the carton 8 Injection Cefotaxime 1g

9 Discolouration noted in May Ibuprofen 400mg Expiry date May 2008

10 10 Missing tablets

11 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 11

12 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 12

13 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 13

14 Global challenges Number of national and international inspections by same party Number of inspections in same site by different parties => Contracts, agreements, mutual recognition (MRAs) Applicability of new technologies in different settings Risks of mistakes, accidents, human errors Counterfeit drugs Internet... 14

15 Problem: Counterfeiting medicines is a major public health concern 15

16 Counterfeiting: increasingly sophisticated business 16

17 Poor illegal manufacturing facility 17

18 Poor control of distribution and sale 18

19 National regulatory and inspection systems --> approx. 1/3 of WHO Member States have well developed regulatory systems, approx.. 1/3 have none In developed countries well organized, controlling national market dossiers evaluation and inspections different approaches used, few MRA In developing countries often difficulties of resources capacity? application of national and international guidelines --> or non-existent. 19

20 World Health Assembly resolution : WHO s Revised Drug Strategy May Concerned about the situation in which (a) one-third of the world s population has no guaranteed access to essential drugs, and (b) poor quality pharmaceutical raw materials and finished products continue to move in international trade;... Taking note of concerns of many Member States about the impact of relevant international agreements, including trade agreements, on local manufacturing capacity and on access to and prices of pharmaceuticals in developing and least developed countries; 20

21 National Medicines Policy Need for common framework to coordinate many different actors in the pharmaceutical field: These include: - regulators (quality, safety and efficacy), - producers (local & international), - users (prescribers & consumers), - health planners & managers, - health finance authorities and researchers. Each have valid interests in the field which may be contradictory or supportive Involves both public & private sectors 21

22 Components of a National Medicines Policy Legislation, Regulation and Guidelines Selection of medicines Supply (incl. procurement & production issues) Quality Assurance Rational Drug Use Economic Strategies for medicines Monitoring & Evaluation of national medicines policy Research Human Resources Development Technical Cooperation among Countries 22

23 Many Actors Involved! Some pro, some against! Medical doctors, specialists, public/private Pharmacists retail and manufacturing Local and international manufacturers, importers Consumers/Patients Media Regulators Insurance Companies.. 23

24 Global Pharmaceutical Market 2006 $566 billion Situation in 2002 US, Europe & Japan 78% 5% 1.3% 24 Source Source Market projected to grow 7.8% annually

25 Usual perceptions may not help to make judgments about medicines Appearance Smell Taste 25

26 In case of medicines they all look nice, mostly do not have any smell, some may have bad taste and are increasingly marketed even through internet (see example below, note that selling medicines via internet may be illegal and products may be counterfeit or substandard) 26

27 WHO s activities towards quality assurance of medicines 27

28 WHO s global guidelines and strategies Requirements for drug registration and model legislation Networking: - among and with regulatory authorities International alerts Counterfeit network Global norms and standards in: - quality control, - production, - inspection, - related regulatory standards, - distribution and - nomenclature 28

29 How does WHO proceed in standard setting? 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, if adopted, published -> WHO Governing bodies -> Recommendation to governments for implementation 29

30 What is a 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: Voting members ("Experts") selected from WHO Expert Advisory Panels Technical advisers Observers: - international organizations, - NGOs, - professional associations 30

31 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 31

32 Scope of WHO Expert Committee on Specifications for Pharmaceutical Preparations Cover medicines: Production Quality Control Quality related regulatory guidelines Inspection Distribution from manufacture to delivery to patient 32

33 WHO s global guidelines - quality control - International specifications (Int.Ph., screening tests, basic tests) WHO Model Certificate of Analysis (COA) for use in trade and procurement Considerations for requesting analysis of drug samples Quality control laboratories good practices for national control labs list of equipment External qc assessment scheme for laboratories 33

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36 WHO s global guidelines - production 36 Good Manufacturing Practices (GMP).. 1. Main principles for pharmaceutical products 2. for starting materials, including active pharmaceutical ingredients pharmaceutical excipients 3. for specific pharmaceutical products: Sterile pharmaceutical products Biological products Investigational pharmaceutical products for clinical trials in humans Herbal medicines Radiopharmaceuticals

37 WHO s global guidelines and strategies - risk analysis Application of risk analysis to production of pharmaceuticals, adopted in

38 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 38

39 WHO s global guidelines - distribution WHO Certification Scheme for Products Moving in International Commerce SMACS new scheme for pharmaceutical starting materials: - model certificate, when inspected by national authority - WHO model for self-assessment for manufacture of pharmaceutical starting materials Good Distribution and Trading Practices for pharmaceutical starting materials (GTDP) Good Distribution Practices (GDP) (new) Good Storage Practices (GSP) 39

40 Implementation of WHO guidelines by.. All dealing with medicines (e.g. nomenclature, INN) 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 40

41 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) 41

42 WHO s operational strategies Work with interested parties and countries to combat counterfeit and substandard drugs (International Convention?) 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 and tools Responding to national and international requests in area of quality assurance for medicines (e.g. for Gobal Fund)

43 WHO efforts aim to improve access to quality medicines Provide standards and norms in area of quality assurance of medicines Pre-qualification project for UN procurement Provide assistance in regulatory area Promote logical order of actions: Priority setting (ABC first ) Capacity building Collaboration and co-operation 43

44 44

45 Further questions?????? 45

46 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 46

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