Transcription of EVALUATION GUIDE FOR GMP REGULATORY COMPLIANCE …
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EVALUATION GUIDE FOR GMP REGULATORY COMPLIANCE …
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 importantDocumentation review2D - Training certification policies/guidelines-Evaluated as part of sub-component 4C2E - Alert/crisis management policies/procedures/guidelines-Evaluated as part of sub-component 8A2 - REGULATORY directives and policies2F - Organisational structure-Evaluated as part of sub-component 11A3A - Details/ scope of GMPC riticalDocum
Component/Sub-Component = Elements of a GMP regulatory compliance programme. For additional information on the level of importance and the evaluation methods, refer to the table “Summary of the Audit Checklist” provided at the beginning of this document.
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