EU GMP Audit Checklist & GAP Analysis
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EU GMP Audit Checklist & GAP Analysis
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This book is for #Auditor and #Auditee in #EU #GMP #Medicinal_Product #Manufacturing organizations.
"Practical EU GMP Audit Checklist and GAP Analysis"
Being an #EU #GMP #Auditor in pharmaceutical industries, you must prepare a #checklist. As a pharmaceutical organization being the #Auditee or planning to host any inspection (#Competent_Authorities, #Customer_Audit, or #third_Parties); you need to perform a #GMP #GAP Analysis of the whole PQS against standard ( EudraLex Vol.4) to make sure you are in #compliance with requirements.
If you are a #Qualified_Persons (#QP) and or part of #Internal #Inspection #QA team, or as a private #Quality #Consultant_Services to #pharmaceutical_organizations, or you are a #GMP_Lead_Auditor, #Biotech company or #startups, and #Business_Developers, this is a handy and practical tool for you.
#Continual_improvement is a critical part of #quality professionals in all industries. A #pharmaceutical_quality_system (#PQS) requires solid #knowledge_management and training regarding personnel competence.
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