Operational Guide to GMP Annexes 1, 15, 16 and 20 – With Best Practices
Operational Guide to GMP Annexes 1, 15, 16 and 20 – With Best Practices
The GMP Annexes represent the fundamental pillars of European pharmaceutical compliance.
This operational guide clearly and practically explains the requirements of four key Annexes:
Annex 1 – Sterile manufacturing and environmental controls (rev. 2023)
Annex 15 – Qualification, validation, deviations, and CAPA
Annex 16 – Batch release and Qualified Person responsibilities
Annex 20 – Quality Risk Management (ICH Q9)
Beyond regulatory interpretation, you’ll find corporate best practices, operational checklists, and real audit cases that allow you to immediately apply the requirements and effectively prepare for any inspection.
What you’ll find inside:
📘 Practical summary of each Annex with operational explanations
✅ Checklists and templates to apply GMP requirements
🚀 Corporate best practices collected from real EMA/FDA audit cases
⚠️ Common inspector findings and how to avoid them
A comprehensive, cross-functional manual designed for QA Managers, QPs, Validation Experts, and Manufacturing Managers who want a single, practical, and up-to-date reference tool.
Format: Professional PDF
Length: 123 operational pages
Updated: December 2025 – compliant with the latest GMP revisions
Available languages: ITA – ENG
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What will I find in this guide?
In addition to operational explanations of the relevant regulations, you will find checklists, templates, real-life cases, and common mistakes to avoid.
How up-to-date is the guide?
The guide includes updated references to the latest EMA and EU GMP regulations, as well as guidance from all international inspection bodies. In the event of future revisions, we expect updates to be made available to buyers.
How long is it and how long does it take to read?
Each guide has a specific length based on the complexity of the topic, but they are all designed for quick reference. You can use it as a daily reference manual.
Who is this guide most useful to?
Junior professionals → to learn quickly and reduce errors.
Senior professionals → to have ready-to-use checklists and templates to share with the team.
Can I download it multiple times or share it?
Once purchased, you can download and keep it. It is for personal or internal business use only, but external redistribution is not permitted.