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

Presented by: Karen GinsburyFor IFF, DenmarkMarch 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.

Special Requests? Expectations?

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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

FDA – what’s newhttp://www.fda.gov/Drugs/NewsEvents/ucm130958.htm

EMA - What’s newhttp://www.ema.europa.eu/ema/index.jsp?

curl=pages/news_and_events/landing/whats_new.jsp&mid=WC0b01ac058004d5c4&jsenabled=true

FDA Guidance Agenda 2011

EMA IWG Workplan 2012http://www.ema.europa.eu/docs/en_GB/document_library/Other/2009/10/WC500004875.pdf

GMPs

GMPs

GDP

Falsified Medicines Legislation and Delegated Act

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm121568.htm

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079645.pdf

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079645.pdf

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079645.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

Who else is out thereOther players:

PIC/sWHOICHUSPISO

http://www.picscheme.org/

http://www.picscheme.org/

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

PIC/s Guidances

PIC/s Guidances

WHO

WHO

WHO

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

PCI Pharmaceutical Consulting Israel Ltd

http://www.ich.org/cache/compo/276-254-1.html

ICH Q8, 9, 10 vs FDA Quality System Guidance

Pharmaceutical DevelopmentQuality Risk ManagementPharmaceutical Quality System

ICH Q8, 9, 10 vs FDA Quality System Guidance

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

Latest guidance is Q11Development and manufacture of drug

substance (API)

Available for download

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

ISOInternational Standards OrganisationVoluntary standardsICH Q10 modelled on ISO 9001:2008

Questions at this point?