Prepare now for the New Annex 1
Additions to the 2020 EU GMP Annex 1 for the Manufacture of Sterile Medicinal Products detail 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.
This paper, by industry experts, details specific items you need to do to prepare for the upcoming EU GMP Annex 1 including:
- System Design
- Monitoring requirements
- Cleaning and Disinfection
- Risk Assessment
- Events and Deviations
Complete the form to get the Beginner Guide to Annex 1.
GET STARTED ON MEETING 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)