Dorna Sheikhi

Practical GAP Analysis & Audit Checklist Dorna Sheikhi 1st edition

This book is for both Auditor and Auditee in EU GDP API & Medicinal Product Distribution organizations.

"Practical EU GDP Audit Checklist and GAP Analysis"

Being an EU GDP 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 GDP GAP Analysis of QS against standard ( based on WHO guidelines and EMA EudraLex Vol.4) to make sure you comply with requirements.

Suppose you are a Responsible Person (RP) and part of an Internal Inspection QA team, a private Quality Consultant Services to pharmaceutical distribution organizations, or a GDP Lead Auditor or Business Developer. In that case, this is a handy and practical tool for you. Continual improvement is a critical part of quality professionals in all industries. A Good Distribution Practice (GDP) requires solid knowledge management and training regarding personnel competence.