Technical Guide for Manufacturing Managers in Pharmaceutical Companies
Technical Guide for Manufacturing Managers in Pharmaceutical Companies
The Manufacturing Manager is the heart of a pharmaceutical facility: they must ensure that production, processes, and personnel meet the highest standards of quality and regulatory compliance.
This operational guide translates EU GMP Annex 1 and Annex 4 into practical, day-to-day procedures, with a focus on cleaning validation, batch record management, and production facility operations.
What you’ll find inside:
⚙️ Annex 1 & Annex 4 explained with a focus on critical production areas
🧼 Cleaning validation made simple with examples and checklists
📑 Batch records: templates and correct completion examples
🚀 Manufacturing best practices to reduce deviations and equipment downtime
Each chapter provides practical tools—comparison tables, operational diagrams, and “common error” boxes.
An indispensable manual for production managers who lead manufacturing teams and must stay GMP inspection-ready.
Format: Professional PDF
Length: 103 operational pages
Updated: 2025 – compliant with the latest Annex 1 revisions
DOWNLOAD A PREVIEW OF THE GUIDE
Available languages: ITA – ENG
Couldn't load pickup availability
HAVE QUESTIONS? CHECK OUT OUR FAQS
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.