DuPont™ - Quality Risk Management for Cleanroom Garment Qualification in the Light of GMP Annex 1
Автор: Fisher Scientific EU
Загружено: 2022-10-24
Просмотров: 638
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Learn about the new GMP Annex 1 and its impact on cleanroom garment systems! 🌟🔬
Find out more information here: http://www.eu.fishersci.com/go/dupont...
The new GMP Annex 1, published on 22 August 2022, introduces significant changes for manufacturers of sterile medicinal products. This new approach emphasizes that all activities in pharmaceutical manufacturing must be governed by QRM principles and documented in a contamination control strategy (CCS). Cleanroom garment systems, being critical in sterile and aseptic manufacturing, must also adhere to these principles.
Simply relying on experience, visual checks, and supplier recommendations will no longer suffice. This webinar will guide you on how to select and validate cleanroom garments under QRM principles, ensuring they become an integral part of your CCS.
Webinar Key Topics:
New GMP Annex 1 requirements
Cleanroom garment qualification
Aseptic pharmaceutical manufacturing
Gain valuable insights and learn about the structured approach to validating cleanroom garments and the scientific test methods available for this validation to meet the expectations of the new GMP Annex 1.
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