Transcription of Evaluation Guide: Good Manufacturing Practice Regulatory ...
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Evaluation Guide: Good Manufacturing Practice Regulatory ...
7 Westferry Circus Canary Wharf London E14 4HB United KingdomTelephone+44 (0)20 7418 8400 Facsimile+44 (0)20 7418 8595 agency of the European Union European Medicines Agency, 2012. Reproduction is authorised provided the source is December 2012 EMA/INS/GMP/758453/2012 Compliance and Inspection Evaluation GUIDE FOR GMP Regulatory COMPLIANCE PROGRAMMEA udit Checklist(Revision 2 including API and common with Canada and PIC/S)JAP audit ChecklistEMA/INS/GMP/758453/2012 Page 2/18 Summary of the audit ChecklistSub-componentImportanceEvaluati on method1A - Empowering legislationCriticalDocumentation review1 - Legislative and Regulatory Requirements and Scope1B - Conflict of interestVery importantDocumentation reviewOn-site Evaluation at Inspectorate2A - Procedures for designating inspectorsVery importantDocumentation review2B - Enforcement Policies-Evaluated as part of sub-component 7B2C - Code of conduct/ Code of ethicsVery importantDocum
Audit Checklist (Revision 2 including API and common with Canada and PIC/S) ... Process validation - Evaluated as part of sub-component 3A 4A - Staffing: Initial qualification Very ... manufacturing authorisation or be identified as holder of a manufacturing authorisation or as a
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