Keeping the c in GMP Presented by Karen

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Keeping the “c” in GMP Presented by: Karen Ginsbury For IFF, Denmark March 2012

EU GMPs Part 1 – Medicinal Products (finished Product) 1. 2. 3. 4. 5. 6. 7. 8. 9. Quality Management (Quality Management System) Updated to incorporate ICH Q 10 concepts Personnel Facilities and Equipment Documentation Production (and packaging) Quality Control (includes QA and QC) Contract Manufacture and Analysis (outsourced operations) Complaints and recalls Self - inspection

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.

Special Requests? Expectations? ? ?

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

FDA – what’s new http: //www. fda. gov/Drugs/ News. Events/ucm 130958. htm

EMA - What’s new http: //www. ema. europa. eu/ema/index. jsp? curl=pages /news_and_events/landing/whats_new. jsp&mid=WC 0 b 01 ac 058004 d 5 c 4&jsenabled=true

FDA Guidance Agenda 2011

EMA IWG Workplan 2012 http: //www. ema. europa. eu/docs/en_G B/document_library/Other/2009/10/W C 500004875. pdf

GMPs

GDP

Falsified Medicines Legislation and Delegated Act

http: //www. fda. gov/Drugs/Guidance. Compliance Regulatory. Information/Guidances/ucm 121568. htm

http: //www. fda. gov/downloads/Drugs/Guidance. Compliance Regulatory. Information/Guidances/ucm 079645. pdf

http: //www. ema. europa. eu/ema/index. jsp? curl=pages/news_and_ev ents/news/2011/11/news_detail_001392. jsp&mid=WC 0 b 01 ac 058004 d 5 c 1

http: //www. ema. europa. eu/ema/index. jsp? curl=pages/r egulation/landing/human_medicines_regulatory. jsp&mi d=WC 0 b 01 ac 058001 ff 89

http: //www. ema. europa. eu/ema/index. jsp? curl=pages/r egulation/general_content_000081. jsp&mid=W C 0 b 01 ac 0580027546

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

http: //www. picscheme. org/

PIC/s Guidances 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

PIC/s Guidances

WHO

WHO

WHO

What is ICH The International Conference On Harmonisation of Technical Requirements For Registration of Pharmaceuticals for Human Use 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, Ph. RMA, JPMA Observers: WHO, EFTA (Norway, Switzerland. . . ), and (Health) Canada PCI Pharmaceutical Consulting Israel Ltd

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

ICH Q 8, 9, 10 vs FDA Quality System Guidance Pharmaceutical Development Quality Risk Management Pharmaceutical Quality System

ICH Q 8, 9, 10 vs FDA Quality System Guidance

ICH Q 8, 9, 10 vs FDA Quality System Guidance The guidance is similar in structure to Q 10 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

Latest guidance is Q 11 Development and manufacture of drug substance (API) Available for download

USP General chapters Chapters below <999> are mandatory Chapters above 1000 and over are NOT mandatory So chapter 11 on reference standards is mandatory Whereas chapter <1117> 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…

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

ISO International Standards Organisation Voluntary standards ICH Q 10 modelled on ISO 9001: 2008

Questions at this point?

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