DuPont: Quality Risk Management for Cleanroom Garment Qualification in the Light of GMP Annex 1

The new GMP Annex 1, published on 22 August 2022, will change the requirements on manufacturers of sterile medicinal products due to its new approach. It will be expected that all activities inside pharmaceutical manufacturing will be governed holistically by QRM principles and documented in a contamination control strategy (CCS). Since cleanroom garment systems are a critical part of sterile and aseptic manufacturing, prevention of escape from garments being the only filter stopping particles generated by operators from contaminating the cleanroom, they should be managed under QRM principles too.

In other words, simply relying on experience, visual checks, and recommendations from the suppliers will not be enough any longer. This raises the question of how cleanroom garments should be selected and validated under QRM principles to become a part of the CCS. This webinar will present a structured approach to validating cleanroom garments, as well as the scientific test methods that are available for this validation, in order to meet the expectations of the new GMP Annex 1.

Webinar key topics:

• New GMP Annex 1
• Cleanroom garment qualification
• Aseptic pharmaceutical manufacturing