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Practical GAP Analysis & Audit Checklist

- EU Good Distribution Practice (GDP) API, Medicinal Product & WHO

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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.

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  • Sprog:
  • Engelsk
  • ISBN:
  • 9788771963182
  • Indbinding:
  • Paperback
  • Sideantal:
  • 79
  • Udgivet:
  • 11. februar 2023
  • Udgave:
  • 1
  • 2-4 uger.
  • 16. december 2024
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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.

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