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1 1 quality-principles

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1 1 quality-principles

  1. 1. Principles of quality control of registered medicines, non- registered medicines andcounterfeits of medical products Jean-Marc Spieser, Head of Department of Biological Standardisation, OMCL Network & HealthCare (DBO), EDQM/ Council of Europe, Strasbourg
  2. 2. Content• EDQM – General Background• Legal environment of registered medicines• Tools available for the quality control of registered medicines• The case of non-registered medicines and their vast environment• How to control non-registered products• Counterfeits of medical products• How, why, and where it happens• How to control it Jean-Marc Spieser, 23/09/09 ©2009 EDQM, Council of Europe, All rights reserved 2
  3. 3. The Council of Europe – Founded in 1949 – Development of European common and democratic principles – 47 member countries – Strasbourg Jean-Marc Spieser, 23/09/09 ©2009 EDQM, Council of Europe, All rights reserved 3
  4. 4. The Council of Europe – Founded in 1949 – Development of European common and democratic principles – 47 member countries – Strasbourg European Convention on Human Rights (protection of individuals) & European Court of Human Rights Jean-Marc Spieser, 23/09/09 ©2009 EDQM, Council of Europe, All rights reserved 4
  5. 5. Jean-Marc Spieser, 23/09/09©2009 EDQM, Council of Europe, All rights reserved 5
  6. 6. The European Union Jean-Marc Spieser, 23/09/09 ©2009 EDQM, Council of Europe, All rights reserved 6
  7. 7. EDQM - Short History 1964: – Convention on the Elaboration of a European Pharmacopoeia signed by 8 Member States 1992: – 1st co-operation contract with the EU Commission on the Biological Standardisation Programme 1994: – European Community signs the Convention – CEP – Implementation of the “Certification of Suitability scheme” – Official Medicines Control Laboratory (OMCL) – Creation of the Network Jean-Marc Spieser, 23/09/09 ©2009 EDQM, Council of Europe, All rights reserved 7
  8. 8. Short History Change of name: the Secretariat of the European Pharmacopoeia becomes the European Department (and later “Directorate”) for the Quality of Medicines (and later “& HealthCare”)… Jean-Marc Spieser, 23/09/09 ©2009 EDQM, Council of Europe, All rights reserved 8
  9. 9. Progressive Transfer of Activities2007 – Blood Transfusion and Organ Transplantation2008 – Pharmaceuticals and Pharmaceutical Care (general pharmaceutical activities)2009 – Cosmetics and Food Packaging Jean-Marc Spieser, 23/09/09 ©2009 EDQM, Council of Europe, All rights reserved 9
  10. 10. Ph.Eur.+ Eur. Observers Jean-Marc Spieser, 23/09/09 ©2009 EDQM, Council of Europe, All rights reserved 10
  11. 11. In the World Jean-Marc Spieser, 23/09/09 ©2009 EDQM, Council of Europe, All rights reserved 11
  12. 12. European Directorate for the Quality ofMedicines & HealthCare (EDQM)Mission: to contribute to the basic human right of access to good quality medicines and healthcare Health is a social human right indispensable for the exercise of all other human rights, for prosperity and democratic stability of people in Europe Jean-Marc Spieser, 23/09/09 ©2009 EDQM, Council of Europe, All rights reserved 12
  13. 13. European Directorate for the Quality of Medicines & HealthCare Jean-Marc Spieser, 23/09/09 ©2009 EDQM, Council of Europe, All rights reserved 13
  14. 14. European Regulatory Network European AuthoritiesEuropean Union European Union European Council Parliament Medicines Agency Commission EMEALondon DG Entreprise BrusselsCouncilof Europe Pharmaceuticals EuropeanDirectorate Ph. Eur.** Pharmaceutical care for the Quality*OMCL :Official Medicines Control of Medicines & HealthCareLaboratories Blood Transfusion Certification*****Ph.Eur : European Pharmacopoeia***Certification : Certification of Suitability EDQMof Monographs of the EuropeanPharmacopoeia Organ Transplantation Strasbourg OMCL* Network Jean-Marc Spieser, 23/09/09 ©2009 EDQM, Council of Europe, All rights reserved 14
  15. 15. Quality AssuranceQuality is obtained through the combination of:• Definition and concept of the product based on development work• Good manufacturing processes steadily under control - starting, in-process and final controls - continuous optimisation - VALIDATED controls of the final product based on suitable and appropriate limited testing (necessary and fully sufficient), All the above should be totally traceable Jean-Marc Spieser, 23/09/09 ©2009 EDQM, Council of Europe, All rights reserved 15
  16. 16. Quality AssuranceAs a general concept QUALITY is manufactured and not only controlled Jean-Marc Spieser, 23/09/09 ©2009 EDQM, Council of Europe, All rights reserved 16
  17. 17. Quality ControlQC Principles • Laboratory of high quality  Good equipment: validated, regularly maintained  Good reagents  Good operators Jean-Marc Spieser, 23/09/09 ©2009 EDQM, Council of Europe, All rights reserved 17
  18. 18. Quality ControlQC Principles • Working environment  QA/QMS in place  Good reporting  Procedures  PTS  Follow up and corrective actions  Procedures in place  Training Jean-Marc Spieser, 23/09/09 ©2009 EDQM, Council of Europe, All rights reserved 18
  19. 19. Regulations• Medicines are submitted to very strict regulations• Each individual preparation requires a Marketing Authorisation (MA) Jean-Marc Spieser, 23/09/09 ©2009 EDQM, Council of Europe, All rights reserved 19
  20. 20. RegulationsA fully detailed registration dossier is filedbased on:Quality – Production using appropriateprocess, suitable ingredients controlled andreleased by validated testsSafety - toxicology and pharmacologyEfficacy – clinical Jean-Marc Spieser, 23/09/09 ©2009 EDQM, Council of Europe, All rights reserved 20
  21. 21. RegulationsAll information and documentationcompiled by producers and/or authorisedimporter are filed to Health Authorities inaccordance with legal procedures andassessed by experts using defined rules  Official Authorisation Jean-Marc Spieser, 23/09/09 ©2009 EDQM, Council of Europe, All rights reserved 21
  22. 22. Regulations• The product is continually assessed throughout its lifetime: Inspections Controls through laboratory testing PharmacovigilanceIf non-conformities are found  administrative, legal and/or financial penalities Jean-Marc Spieser, 23/09/09 ©2009 EDQM, Council of Europe, All rights reserved 22
  23. 23. Tools• The MAA: QA part• CTD part• Pharmacopoeias such as National Pharmacopoeias, International Pharmacopoeias, Ph. Eur., USP- General Chapters- Individual Monographs• Guidelines/ aide mémoire for inspections, sampling• Literature/ data Jean-Marc Spieser, 23/09/09 ©2009 EDQM, Council of Europe, All rights reserved 23
  24. 24. Sampling• Ensure representativity- withdrawn by authority or mandated persons- not by manufacturer- define place where samples are taken, how and how much• Ensure good storage- temperature- humidity- transportation Jean-Marc Spieser, 23/09/09 ©2009 EDQM, Council of Europe, All rights reserved 24
  25. 25. Non registered “medicines”• Traditional origin- Mostly oral and very restricted data available- Origin not always traceable but should be- How to control the claims and attributes given to these products- What to control, which criteria and indicative parameters• Legal environment?? Jean-Marc Spieser, 23/09/09 ©2009 EDQM, Council of Europe, All rights reserved 25
  26. 26. Non registered “medicines”• Controls- Based on visual recognition of the substance or the plant- If plant is chopped or ground use of of organoleptic properties, microscopic aspect and basic wet chemistry(test tube ) assays- Important to verify that the right species is there- Need of specialists Jean-Marc Spieser, 23/09/09 ©2009 EDQM, Council of Europe, All rights reserved 26
  27. 27. Non registered “medicines”• Controls- Based on traditional knowledge- Sometimes described in literature bust mostly oral- No official standards but need to develop it in known recognised compendia- Be carefull on adulterated, counterfeits- ILLEGAL Jean-Marc Spieser, 23/09/09 ©2009 EDQM, Council of Europe, All rights reserved 27
  28. 28. COUNTERFEITED MEDICINES• By definition not known• When and where it will happen- ILLEGAL of course by defition- 2 basic areas attacked - Blockbusters, expensive, well known, attractive…….organised crime - Local , smallsmugglers for small quantities of every possible things Jean-Marc Spieser, 23/09/09 ©2009 EDQM, Council of Europe, All rights reserved 28
  29. 29. COUNTERFEITED MEDICINES• How to combat these products- Through multisectorial surveillance - Forensic analysis - Custom vigilance - Police controls Jean-Marc Spieser, 23/09/09 ©2009 EDQM, Council of Europe, All rights reserved 29
  30. 30. COUNTERFEITED MEDICINES• To start with – Visual check of packaging very important• Followed by analysis – Simple and more and more sophisticated• Need to have comparator – Reference substance(s) – Authentic samples Jean-Marc Spieser, 23/09/09 ©2009 EDQM, Council of Europe, All rights reserved 30
  31. 31. COUNTERFEITED MEDICINES• Simple comparative tests• Then sophisticated – HPLC using different detectors, coupled with mass spectrum• Usefulness of network Jean-Marc Spieser, 23/09/09 ©2009 EDQM, Council of Europe, All rights reserved 31
  32. 32. Thank you!Jean-Marc Spieser, 23/09/09©2009 EDQM, Council of Europe, All rights reserved 32

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