GMP risk assessment in light of the Annex 1

 
 
 
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Date/Time: Tuesday, February 2, 2021 10:00 - 10:45 AM CEST

According to current GMP guidelines and Annex 1 all aseptic manufacturing of sterile products should be managed by applying Quality Risk Management principles, that provide a proactive means of identifying, scientifically evaluating and controlling potential risks to quality. Because many factors contribute to the overall quality and suitability of cleanroom garment systems, the cleanroom garment qualification process is very important.

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