Aseptic Process Simulation (Media Fill) – Practical Guide according to EU GMP Annex 1
Aseptic Process Simulation (Media Fill) – Practical Guide according to EU GMP Annex 1
Aseptic Process Simulation (APS), also known as Media Fill, is a key requirement of EU GMP Annex 1 (Rev. 2022) to demonstrate the effectiveness of aseptic processes and the Contamination Control Strategy (CCS).
This practical guide supports the design, execution, and management of APS, translating regulatory requirements into operational activities and audit-ready documentation.
What You Will Find in This Guide
- APS requirements according to EU GMP Annex 1, FDA, PIC/S, and WHO
- Study design (worst-case approach, duration, formats, interventions)
- Integration with Quality Risk Management (ICH Q9) and PQS (ICH Q10)
- Media Fill execution and environmental monitoring
- Acceptance criteria, failure management, and CAPA
- APS documentation, data integrity, and audit readiness
Target Audience
Quality Assurance · Sterile Manufacturing · Microbiology · Validation · Engineering · QP · Management
Product Details
Format: Professional PDF
Length: 127 pages
Updated to: January 2026
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.