EU GMP Annex 1 – Insights and Updates
The new chapter addition to the 2020 EU GMP Annex 1 for the Manufacture of Sterile Medicinal Products details viable and non-viable environmental and process monitoring to a degree not previously seen. It’s made clear that process monitoring and risk assessment is essential to the development of an effective contamination control strategy.
Trend analysis and its impact on the contamination control strategy is now an essential activity and is referenced multiple times. There is also clear differentiation between qualification and monitoring, and quality risk management concepts are interwoven into each section.
Here are just a few of the topics this paper covers:
- System Design
- Cleaning and Disinfection
- Risk Assessment
- Events and Deviations
Interested in learning more?
Complete the form on the right to get the full Beginner Guide to Annex 1.
Particle Measuring Systems has complete cleanroom contamination control solutions for you including:
- Our Contamination Control Advisory Services who can conduct an expert Risk Assessment for your pharmaceutical processes
- PMS cleanroom particle counters including portable/mobile and fixed/remote
- Microbial monitors including portable/mobile, fixed/remote, and single use.
- Data management software from Particle Measuring Systems
Contact us today to learn more about how we can help you with your compliance efforts.