Practical Eu Gmp Audit Check List & Gap Analysis

Beskrivelse

This book focuses on the importance of continual improvement for quality professionals, especially within the pharmaceutical industry. It highlights the need for strong knowledge management and training to ensure personnel competence in pharmaceutical quality systems.

An essential resource for EU GMP audit checklists and gap analysis tailored to the pharmaceutical sector.

While GMP checklists exist from sources outside the EU GMP for Medicinal Products, this book was inspired during GMP Lead Auditor training and the journey to becoming an Internal Auditor. The idea emerged as a response to the ongoing updates in EudraLex, filling a gap that hadn’t been addressed before.

The author recognized a shortage of comprehensive EU GMP checklist and GAP analysis materials specifically designed for the pharmaceutical industry within EU member states. The concept gradually took shape over nearly a year, with the draft evolving to cover various aspects and directions relevant to the field.