QP Current Practices Challenges and Mysteries_Almac_March2012

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Continued…• Biological Drug Substance– Critical or major deviations / OOS for APImanufacture /storage / testing• Why?– GMP starts from maintenance of the WorkingCell Bank– QP must assess to identify possible impact on• Product quality• Patient safety
Continued…• Stability Memo and supporting stability data– In support of extension plan– Must be comprehensive– Substantial Amendment may need to be filed later• Why?– QP must confirm shelf life for Drug Productcomplies with available stability data.
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 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 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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