Information Exchange and International Collaboration in Quality Testing

1. 3-2 Information Exchange and International Collaboration in Quality Testing Richard Wanko Interregional Seminar for Quality Control Laboratories involved in WHO Prequalification Programme and/or participating in respective sampling and testing projects, Nairobi, Kenya, 23-25 September 2009

2. Outline • Definition and role of OMCLs • Why collaboration between OMCLs / Why networking? • How does a network operate? • Which tools facilitate information exchange and collaboration? • Example of the General European OMCL Network (GEON)

3. Definition of an OMCL in Europe An Official Medicines Control Laboratory (OMCL) is a public institution, which only performs laboratory testing for a Competent Authority, independently from the manufacturer, for medicinal products prior to and/or after marketing for the general surveillance of medicines in relation to the safety of human patient and/or animals. Reference: PA/PH/OMCL (07) 89, current version

4. OMCL as Recognised Term in Europe The Term “Official Medicines Control Laboratory” can be found in several articles of the EU legislation Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use, as amended Article 19;Procedures relevant for marketing authorisation Articles 111 and 114;Supervision and Sanctions 1/3

5. OMCL as Recognised Term in Europe Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products, as amended Article 23;Procedure for marketing authorisation Articles 80 and 82;Supervision and Sanctions 2/3

6. OMCL as Recognised Term in Europe • Regulation (EC) No 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency Article 7 / 32Article 57 3/3

7. Role of an OMCL in Europe • Post-marketing surveillance programme • Sampling and testing of generic medicines • Analysis of unlicensed (unauthorised) medicines • Analysis of illegal copies (counterfeits / falsifications) • Pre-marketing sampling and analysis • Support in evaluation of the quality part of MA files • Support of pharmacovigilance assessments • Support of GMP inspections as experts • Support in the framework of the European Pharmacopoeia • Evaluation of defect reports

8. Other Tested Products • Cosmetics • Medical devices • Diagnostics • Food • Feed (premixes) for veterinary use • “Borderline products”

9. Why Should OMCLs Collaborate? • Lab equipment and qualified manpower becomes more and more expensive – pooling of resources • Testing becomes more and more complex – centres of expertise / know-how • Workload is increasing – by sharing work the “coverage rate” of medicines available on the market becomes higher • Globalisation increases danger of inferior quality – cross boarder co-operation

10. Why Having a Network? • To promote and facilitate Mutual Recognition by developing codified procedures • To provide a platform for exchange of information on evaluation and status of products • To foster the use of harmonised approaches to the control of medicinal products • To create a unified voice for feedback and exchange with Regulatory Authorities, GMP inspectors, Pharmacovigilance experts and Manufacturers / within the Pharmacopoeia Expert Groups • To facilitate work-sharing and maximisation of resources

11. Basic Principle of Network Mutual Recognition Implies • Common harmonised work procedure • Same rules of decision for compliance / non compliance • Work-sharing • Common QA systems and technical competence indicators / performance measurements =>Need for a structured Network with codified rules

12. Tools of a Network Policy and Technical documents • Terms of Reference • Procedures • Guidelines • Position Papers ... Establishment of rules 1/6

13. Tools of a Network Human Resources • Expert Working Groups for elaboration of rules • Advisory Board for consultation • Committee for decision taking • Secretariat for coordination Implementation of rules 2/6

14. Tools of a Network Common QA standards • Reference to the same quality standards • Audit of the QA/QM system • Proficiency Testing Scheme (PTS) Harmonisation and standardisation 3/6

15. Tools of a Network Joint testing programmes • Collaborative studies (more technique-related exercise) • Market surveillance studies (more-product related exercise) • Testing of products based on the same Marketing Authorisation dossier Work-sharing 4/6

16. Tools of a Network IT platforms • Group E-mailing lists • Electronic document deposit sites with regulated (restricted) access • Knowledge databases Safe distribution of information 5/6

17. Tools of a Network Training • Technical and QA training • IT training • Tutorials • Training visits Improvement of competence 6/6

18. GEON General European Official Medicines Control Laboratory Network =>Concerted effort in medicines control

19. GEON – Some Facts • Network created in 1994/1995 • About 70-80 OMCLs from (almost) all Ph.Eur. signatory states and some observer countries (about 35 countries) • Financial support from EU • Sharing of work, equipment, competences • Aims for • Common rules, working and Quality Assurance standards • Mutual confidence and recognition of results

20. Rules of the GEON Defined in Terms of Reference, which includes • Core document • Annex 1: Definition of an OMCL and OMCL status within the GEON • Annex 2: Factors for determining OMCL status within the GEON • Annex 3: List of Network Members Reference: PA/PH/OMCL (07) 79, 89, 90 and (09) 45 current version

21. GEON Membership Criteria • Guarantee of independency / independent judgement • Public funding • Avoidance of conflict of interest • Implementation of Ph.Eur. • Clear mandate as to responsibilities and duties • Clear rules for subcontracting activities • Implementation of the ISO/IEC 17025 standard

22. Types of GEON Membership • Full member • Associated member OMCLs of countries inside or outside of Europe that are observers to the European Pharmacopoeia Commission (Morocco, Canada, Australia) Recent candidates for membership: the former Yugoslav Republic of Macedonia, the Russian Federation, Israel

23. The Ph.Eur. Members 37 Membersincluding Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Montenegro, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, the former Yugoslav Republic of Macedonia, Turkey, United Kingdom, and the European Union.  Most recent member: Poland (2006)

24. The Ph.Eur. Observers 23 Observerstates including the World Health Organisation plus 8 European countries (Albania, Armenia, Belarus, Georgia, Kazakhstan, Moldova, Russian Federation and Ukraine) and 14 non-European countries (Algeria, Argentina, Australia, Brazil, Canada, China, Israel, Madagascar, Malaysia, Morocco, Senegal, Syria, Tunisia, United States of America). Last observerships: Argentina, Armenia and Moldova (2008), Republic of Belarus (2007), the Russian Federation and Kazakhstan (2006).

25. « Specific » GEON Members Control laboratories acting as OMCL of the Competent Authority due to lack of such institutions or specific technical competences Precondition • All other GEON Membership criteria must be fulfilled • Funding only by the mandating authority • Laboratory acts exclusively as control laboratory of this authority • Authority transfers the responsibility for the given field of activity to that laboratory and the activity is not of an occasional nature or restricted to a specific analytical technique or product.

26. GEON Meetings • Annual Meeting of the GEON once a year in a member state (principle of rotating location) - decision taking body • GEON Advisory Group twice a year at the EDQM - advising body • GEON Working Groups ad-hoc meetings upon request - Elaboration of (technical / QA) documents • EDQM – Secretariat of the GEON

27. Other Regular Network Meetings Specific Networks • Annual Meetings of the CAP and OCABR testing groups • Advisory Groups for CAP testing and OCABR testing • No Advisory Group for MRP/DCP testing, but plenary meetings twice a year

28. GEON Technical Documents Procedures Guidelines OCABRGuidelines QA

29. OMCL Network Handbooks

30. OMCL Network IT Tools Extranet sites OMCLnet, CAPnet, MRPnet, OCABRnet as document deposit with regulated access Storage of • Network documents (policy and technical documents) • Reports • Meeting files (presentations, agendas, minutes...) • Training files

31. Example OMCLnet

32. OMCL Network IT Tools Databases OMCL inventory database, MRP/DCP product testing database, OCABR batch databaseas data pool Information about • OMCLs • Competences • Testing activities • Test results

33. Example OMCL Inventory Database

34. Network Training - Examples • Training of users of the MRP/DCP product testing database and OCABR batch database • Training of auditors for the MJA programme • Counterfeit training for OMCLs • OCABR training for OMCLs

35. GEON QA Programme • Mutual Joint Audits (MJA) Peer assessment of the QA system against ISO 17025 • Mutual Joint Visits (MJV) Peer assistance to establish QA system according to ISO 17025 1/2

36. GEON QA Programme • Tutorials Peer assistance targeting specific test methods / techniques • Proficiency Testing Scheme Tailor-made programmes for chemical and biological OMCLs New in the programme: PTS for radiopharmaceuticals Analysis of suspicious unknown product (SUP) 2/2

37. Activities of the GEON General Activities • Elaboration of common network strategies • General QA activities • Market surveillance and collaborative studies • Educational programmes • Applied analytical research and regulatory development 1/2

38. Activities of the GEON EU-specific Activities • Centrally Authorised Product (CAP) testing • Official Control Authority Batch Release (OCABR) • Mutual Recognition Procedure/Decentralised Procedure (MRP/DCP)-product testing 2/2

39. Role of the Secretariat (EDQM) • General coordination of activities • Definition of an OMCL and membership to the Network • Clear rules and procedures • Fostering of mutual confidence and recognition • Implementation of QA system • Audits of OMCLs by peers (EDQM and Network members) • Proficiency testing studies (PTS) • Training courses (procedures, QA and techniques in OMCLs, databases) • Assistance (tutorials, visits,…) 1/2

40. Role of the Secretariat (EDQM) • Organisation batch release for biologicals • Elaboration of guidelines • Organisation post-marketing surveillance studies (CAPs, MRPs, DCPs, nationally authorised medicines) • Supply of tools (databases, IT platforms etc.) 2/2

41. Interaction National and European Partners EU Commission DG Enterprise Legislation Complementary, No Duplication, Interactivity EDQM (CoE) OMCL Network Quality Control EMEA Evaluation Inspections Reciprocal participation in expert groups NATIONAL MEDICINES AGENCIES

42. An “Intercontinental Dimension “ EDQM Know-how Specific countries such as USA, JP, Canada, Australia, Morocco, EDQM provides assistance to Africa and ASEAN countries Complementary, Interactivity: work-sharing No duplication, common approaches WHO Standards and quality EDQM is collaborative centre of WHO for antibiotics Two-way participation in activities and studies MEDICINES AGENCIES NATIONAL AUTHORITIES

43. GEON Structure

44. Contribution of the GEON Activities of the GEON contribute to: • Public health and patient protection in field of medicines • Animal welfare • Economical use of resources • Cost efficiency = co-financing of projects of common interest between interested stakeholders / partners (EU Commission, EMEA, WHO…), fees from industry

45. Conclusion – Why Networking? • Cost saving / Time saving • Quicker and better informed; better preparedness in case of incidences • Better / stronger positioning against other stakeholders (Pharmaceutical Industry) • Enlargement of capacity; higher sample throughput • Enlargement of expertise / know-how and…

46. Conclusion – Why Networking? ENLARGEMENT OF THE HORIZON

47. http://www.edqm.eu Thank you for your attention Dr Richard Wanko Scientific Officer Council of Europe European Directorate for the Quality of Medicines and HealthCare (EDQM) Biological Standardisation, OMCL Network & HealthCare Department (DBO) 7 alleeKastner, CS 30026 F- 67081 Strasbourg, France Tel.: + 33 (0) 3 90 21 40 13 Fax: + 33 (0) 3 88 41 27 71 E-mail: richard.wanko@edqm.eu