Qualified Person (QP) Operational Guide – Annex 16 / Batch Release
Qualified Person (QP) Operational Guide – Annex 16 / Batch Release
Become even more effective and confident in your role with the Operational Guide for Qualified Person (QP). This professional guide, written with clarity and rigor, takes you step by step through the key regulatory obligations — particularly Annex 16 (EU GMP) — and the legal responsibilities associated with the release of pharmaceutical batches.
What you’ll find inside:
Annex 16 simplified: practical explanations for applying it to your daily processes
Legal responsibilities illustrated with real examples and practical advice
Quick batch release checklists — ready to use
Error-prevention tips for stress-free EMA/FDA audits
This guide is not just theory — it’s a hands-on manual, built on real-world pharmaceutical experience, written in clear language, and packed with immediately usable tools.
Additionally, each copy is automatically updated to the latest regulatory versions, ensuring reliability and ongoing compliance.
Format: Professional PDF, optimized for PC, tablet, and mobile
Length: 153 pages
Available languages: ITA – ENG
DOWNLOAD A PREVIEW OF THE GUIDE:
| Preview ITA | Preview 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.