The new GMP Annex 1 became effective on the 25th of August, and it further emphasizes the need for strategic contamination control.
This webinar will review how portable particle counters are an essential tool to meet and exceed the latest requirements of GMP Annex 1 in your manufacturing process.
We will identify the aspects of Annex 1 that have, and have not, changed from previous versions, and the role of portable particle counters in meeting the revised regulations.
The webinar will cover:
- Revised Annex 1 document for portable particle counting
- Changes for cleanroom classification for particle monitoring
- Particle limit classifications for particle monitoring
- Changes for particle counts in cleanroom monitoring
- Risk management
- Audit Trails and other supporting functions included in instrumentation and how it should be utilized
