Practical Gap Analysis & Audit Checklist

Beskrivelse

This book is designed for both auditors and auditees working within EU GDP API and Medicinal Product Distribution organizations. It offers practical guidance for conducting audits and gap analyses to ensure compliance with pharmaceutical distribution standards.

A hands-on resource for EU GDP audit checklists and gap analysis in pharmaceutical distribution.

If you're an EU GDP auditor in the pharmaceutical sector, preparing a thorough checklist is essential. For pharmaceutical organizations acting as auditees or preparing for inspections-whether by Competent Authorities, customer audits, or third parties-conducting a GDP gap analysis of your quality system against standards is crucial. This analysis is based on WHO guidelines and EMA EudraLex Volume 4 to help guarantee compliance.

This book is especially useful if you are a Responsible Person (RP), part of an Internal Inspection QA team, a private Quality Consultant serving pharmaceutical distribution companies, a GDP Lead Auditor, or a Business Developer. It serves as a practical tool to support continual improvement, which is vital for quality professionals across all industries.

Good Distribution Practice (GDP) demands strong knowledge management and ongoing training to maintain personnel competence, and this guide helps you achieve that effectively.

Yderligere information