QP Current Practices Challenges and Mysteries_Almac_March2012

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QP Declaration• May be confused with the lot specific QPStatement of Release• Signed by QP, confirming…manufacturingsites to be used outside of the EEA operateto equivalent EU GMP standards• Protocol and Product specific• Submitted as part of the CTA to the relevantCompetent Authority• QP is taking personal responsibility forcertifying the sites
QP Declaration• All sites verified- only sites of manufacture,packaging and labelling detailed– Czech Republic- QP Declaration to alsoincluded sites of release and stabilitytesting– Sweden- Details of site verification to beprovided in an additional memo• May be issued at client risk pendingfavourable outcome of inspection/audit• Determined as part of Risk Assessment
Page 2 and 3: Agenda• QP Roles and Responsibili
Page 4 and 5: QP Roles andResponsibilities• IMP
Page 6: QP RELEASE PROCESS1. SupplyChainVer
Page 10 and 11: Sites to be verified• Biological
Page 12 and 13: Sites to be verified• Drug produc
Page 14 and 15: Continued…• Who can confirm EU
Page 18 and 19: Common Pitfalls• All sites used i
Page 20 and 21: Common Pitfalls• Site address or
Page 22 and 23: Study SpecificDocumentation• Reme
Page 24 and 25: Continued…• Document of greates
Page 26 and 27: Continued…Contains or makes refer
Page 28 and 29: QP RELEASE PROCESS3. LotSpecificInf
Page 30 and 31: Documentation requiredFor Drug Subs
Page 32 and 33: Continued…• Biological Drug Sub
Page 34 and 35: Continued…• Memo to confirm the
Page 36 and 37: Continued• Non- EU Licensed Drug
Page 38 and 39: ContinuedLicensed Drug Products- Do
Page 40 and 41: QP release• Remember QP Legal Dut
Page 42 and 43: Updates• QP Facilitation Programm
Page 44 and 45: Continued…• Common goal for bot
Page 46: Summary• QP Roles and Responsibil

QP Current Practices Challenges and Mysteries_Almac_March2012

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