The revision of the EU GMP Annex 1 for the manufacturing of sterile products was published and will be effective on the 25th of August, 2023. It requires that manufacturers of sterile products will apply the principles of Quality Risk Management (QRM) to the design and control of facilities, equipment (such as cleanroom garments), systems and procedures used for the manufacture of all sterile products.
Since operators represent the highest contamination risk inside pharmaceutical cleanrooms, the cleanroom garment systems are a critical part of the contamination control strategy. The new EU GMP Annex 1 is asking for a proactive, wholistic, risk-based and data-driven process validation.
Join DuPont GMP Annex 1 Webinars, taking place on Monday, June 5 at 10am-11am CET or on Friday, June 9 at 10am-11am CET which will present a structured approach to validating cleanroom garments, as well as the scientific test methods that are available for this validation, to meet the expectations of the new GMP Annex 1.
Register for Webinar June 5: Click here
Register for Webinar June 9: Click here