Quality Risk Management for Cleanroom Garments GMP Annex 1
According to current GMP guidelines 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.
- Current regulatory guidance GMP Annex 1
- Understanding contamination process
- Step by step cleanroom garment qualification process