QP Current Practices Challenges and Mysteries_Almac_March2012

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Sites to be verified• Drug product– <strong>QP</strong> assessment for compliance with EU orequivalent EU GMP• Manufacturing• Analytical Testing (release <strong>and</strong> stability)• Storage
Sites to be verifiedWhat does the process involve?• Risk Assessments to formally document theprocess of verification• Identify each site involved• Determine if on-site audit is required• Justification provided if on-site audit is notrequired
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 14 and 15: Continued…• Who can confirm EU
Page 16 and 17: QP Declaration• May be confused w
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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