Presented by: Karen Ginsbury For IFF, Denmark March 2012.
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Transcript of Presented by: Karen Ginsbury For IFF, Denmark March 2012.
EU GMPs Part 1 – Medicinal Products (finished Product)1. Quality Management (Quality Management
System)Updated to incorporate ICH Q10 concepts
2. Personnel3. Facilities and Equipment4. Documentation5. Production (and packaging)6. Quality Control (includes QA and QC)7. Contract Manufacture and Analysis
(outsourced operations)8. Complaints and recalls9. Self - inspection
Course ObjectiveUpdate with current regulationsUpdate on regulations and guidance in the
makingProactively plan improvements to the quality
management system to:Reduce deviationsReduce non conformancesEnhance complianceEnsure positive inspection outcomes.
Some tips before we get goingCheck out:FDA what’s newEMA what’s newFDA Guidance agenda 2011 (2012 not yet
out)EMA IWG workplan 2012And don’t forget to keep checking the websites
EMA - What’s newhttp://www.ema.europa.eu/ema/index.jsp?
curl=pages/news_and_events/landing/whats_new.jsp&mid=WC0b01ac058004d5c4&jsenabled=true
EMA IWG Workplan 2012http://www.ema.europa.eu/docs/en_GB/document_library/Other/2009/10/WC500004875.pdf
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2011/11/news_detail_001392.jsp&mid=WC0b01ac058004d5c1
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/landing/human_medicines_regulatory.jsp&mid=WC0b01ac058001ff89
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000081.jsp&mid=WC0b01ac0580027546
PIC/s Guidances
http://www.picscheme.org/publication.php?id=4GMP guide
http://www.picscheme.org/publication.php?id=14Aide memoires
http://www.picscheme.org/publication.php?id=8Guidance Documents
PCI Pharmaceutical Consulting Israel Ltd
What is ICHThe International Conference
OnHarmonisation of
Technical RequirementsFor
Registration of Pharmaceuticalsfor Human Use
PCI Pharmaceutical Consulting Israel Ltd
ICH MembersRegulators 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
ICH Q8, 9, 10 vs FDA Quality System Guidance
Pharmaceutical DevelopmentQuality Risk ManagementPharmaceutical Quality System
ICH Q8, 9, 10 vs FDA Quality System GuidanceThe 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
USPGeneral chaptersChapters below <999> are mandatoryChapters above 1000 and over are NOT mandatorySo chapter 11 on reference standards is mandatoryWhereas chapter <1117> on Good Microbiological
Laboratory Practice is NOT mandatoryBut general chapters can be a useful source of
informationAnd 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