Review of Annex 1: 2022
Read this paper for an easy-to-understand explanation of the meaning of the newest EU GMP Annex 1 2022.Ā The charts provide a section-by-section practical explanation and interpretation of Annex 1.
Knowledge Category: Air
The Continuous Monitoring Concept for Pharmaceutical Manufacturing
Continuous monitoring helps ensure the sterility of clean manufacturing within the pharmaceutical industry. In the pharmaceutical field, one of the main objectives required by regulatory guidelines is to preserve the sterility of cleanrooms. Cleanrooms are controlled areas where contamination levels are monitored and managed to meet a defined cleanliness level. To reach this goal, it is important to ensure that each GMP requirement is respected over time.
Semiconductor Particle Counting for Real-time Monitoring
Semiconductor particle monitoring case studies on the use of the Airnet II Particle Counter to improve yields within manufacturing.
Alarm Rationale for Continuous Particle Counting Systems
Alarm rationale is a critical component when designing your cleanroom environmental monitoring system.Ā Understand the factors and considerations.