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
- Monitoring
- Cleaning and Disinfection
- Risk Assessment
- Microflora
- Events and Deviations
- More…
Complete the form to get the 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
- Customizable, turnkey Facility Monitoring Systems (FMS)
Relevant Information
Viable Monitoring Solutions to Prepare Your Contamination Control Strategy (CCS) for Annex 1 FAQ
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Viable Monitoring Solutions to Prepare Your Contamination Control Strategy (CCS) for ANNEX 1
Potential Cleanroom Sampling Points per Annex 1 Draft (Part 4 of 5)
Life Sciences & Pharmaceutical Industry Contamination Control
Annex 1 Single Use Systems (SUS) Requirements & the BioCapt Single Use Impactor
