1. Presented by: Karen Ginsbury For IFF, Denmark March 2012

2. EU GMPs Part 1 – Medicinal Products (finished Product) 1. Quality Management (Quality Management System) Updated to incorporate ICH Q10 concepts 2. Personnel 3. Facilities and Equipment 4. Documentation 5. Production (and packaging) 6. Quality Control (includes QA and QC) 7. Contract Manufacture and Analysis (outsourced operations) 8. Complaints and recalls 9. Self - inspection

3. Course Objective Update with current regulations Update on regulations and guidance in the making Proactively plan improvements to the quality management system to: Reduce deviations Reduce non conformances Enhance compliance Ensure positive inspection outcomes.

4. Special Requests? Expectations? ?

5. Some tips before we get going Check out: FDA what’s new EMA what’s new FDA Guidance agenda 2011 (2012 not yet out) EMA IWG workplan 2012 And don’t forget to keep checking the websites

6. FDA – what’s new http://www.fda.gov/Drugs/ NewsEvents/ucm130958.htm

7. EMA - What’s new http://www.ema.europa.eu/ema/index.jsp?curl=pages /news_and_events/landing/whats_new.jsp&mid=WC0 b01ac058004d5c4&jsenabled=true

8. FDA Guidance Agenda 2011

9. EMA IWG Workplan 2012 http://www.ema.europa.eu/docs/en_G B/document_library/Other/2009/10/W C500004875.pdf

11. GMPs

13. GDP

14. Falsified Medicines Legislation and Delegated Act

15. http://www.fda.gov/Drugs/GuidanceCompliance http://www.fda.gov/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/ucm121568.htm

16. http://www.fda.gov/downloads/Drugs/GuidanceComplianceR egulatoryInformation/Guidances/ucm079645.pdf

19. http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_ev ents/news/2011/11/news_detail_001392.jsp&mid=WC0b01ac058004 d5c1

20. http://www.ema.europa.eu/ema/index.jsp?curl=pages/r egulation/landing/human_medicines_regulatory.jsp&mi d=WC0b01ac058001ff89

21. http://www.ema.europa.eu/ema/index.jsp?curl=pages/r egulation/general/general_content_000081.jsp&mid=W C0b01ac0580027546

22. Who else is out there Other players: PIC/s WHO ICH USP ISO

23. http://www.picscheme.org/

25. PIC/s Guidances http://www.picscheme.org/publication.php?id=4 http://www.picscheme.org/publication.php?id=4 GMP guide http://www.picscheme.org/publication.php?id=14 Aide memoires http://www.picscheme.org/publication.php?id=8 Guidance Documents

26. PIC/s Guidances

28. WHO

31. PCI Pharmaceutical Consulting Israel Ltd What is ICH The International Conference On Harmonisation of Technical Requirements For Registration of Pharmaceuticals for Human Use

32. PCI Pharmaceutical Consulting Israel Ltd ICH Members Regulators and industry as equal partners in scientific and technical discussions of testing procedures required to ensure and assess safety, quality and efficacy of medicines Regulators: EU (EMEA), FDA, MHLW (Japan) Industry (trade organizations): EFPIA, PhRMA, JPMA Observers: WHO, EFTA (Norway, Switzerland...), and (Health) Canada

33. PCI Pharmaceutical Consulting Israel Ltd http://www.ich.org/cache/compo/276-254-1.html

34. ICH Q8, 9, 10 vs FDA Quality System Guidance Pharmaceutical Development Quality Risk Management Pharmaceutical Quality System

35. ICH Q8, 9, 10 vs FDA Quality System Guidance

36. The guidance is similar in structure to Q10 but far more detailed and more tied in with the GMPs For those intimately involved in establishing, maintaining and continually improving a QMS that meets US FDA requirements and expectations – it is worth a read

37. Latest guidance is Q11 Development and manufacture of drug substance (API) Available for download

38. USP General chapters Chapters below are mandatory Chapters above 1000 and over are NOT mandatory So chapter 11 on reference standards is mandatory Whereas chapter on Good Microbiological Laboratory Practice is NOT mandatory But general chapters can be a useful source of information And USP has a vendor qualifcation program…

39. Ph. Eur. and EDQM (European Directorate on Quality of Medicine) Certify starting materials in a formal qualification and inspection program Includes BSE / TSE certificates

40. ISO International Standards Organisation Voluntary standards ICH Q10 modelled on ISO 9001:2008

41. Questions at this point?