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. 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
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 NewsEvents/ucm htm
EMA - What’s new /news_and_events/landing/whats_new.jsp&mid=WC0 b01ac058004d5c4&jsenabled=true
FDA Guidance Agenda 2011
EMA IWG Workplan B/document_library/Other/2009/10/W C pdf
GMPs
GDP
Falsified Medicines Legislation and Delegated Act
RegulatoryInformation/Guidances/ucm htm
egulatoryInformation/Guidances/ucm pdf
ents/news/2011/11/news_detail_ jsp&mid=WC0b01ac d5c1
egulation/landing/human_medicines_regulatory.jsp&mi d=WC0b01ac058001ff89
egulation/general/general_content_ jsp&mid=W C0b01ac
Who else is out there Other players: PIC/s WHO ICH USP ISO
PIC/s Guidances GMP guide Aide memoires Guidance Documents
PIC/s Guidances
WHO
PCI Pharmaceutical Consulting Israel Ltd 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, PhRMA, JPMA Observers: WHO, EFTA (Norway, Switzerland...), and (Health) Canada
PCI Pharmaceutical Consulting Israel Ltd
ICH Q8, 9, 10 vs FDA Quality System Guidance Pharmaceutical Development Quality Risk Management Pharmaceutical Quality System
ICH Q8, 9, 10 vs FDA Quality System Guidance
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
Latest guidance is Q11 Development and manufacture of drug substance (API) Available for download
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…
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 Q10 modelled on ISO 9001:2008
Questions at this point?