Annex 1 EU GMP Sterile manufacturing: Key changes and Contamination Control Strategy

Description:

The new annex 1 of EU guidelines to GMP for medicinal products for human and veterinary use regarding manufacture of sterile medicinal products was finally published on August 22nd, 2022 after many years of discussions. 

Scheduled to come into operations in 1 year from now, there are many key changes to consider such as implementation of Contamination Control Strategy, requirements for usage of RABS technology and isolators as the best way to ensure quality and safety of sterile products, detailed requirements for filter sterilisation, Form-Fill-Seal (FFS), Blow-Fill-Seal, lyophilization, closed systems and Single use systems (SUS) with new guidance values; more requirements on training and qualification of employees working in clean rooms grade A and B, and many more.

We would like to invite you to a short webinar in order to share with you what the main changes are with focus on Contamination Control Strategy and answer your questions. Our objective is to further propose our services in order to help you get compliant with this new annex before the deadline for implementation which is August 25th, 2023. We know that the time is short and are willing to put our expertise at your service.

Retrieve!

Speakers: 

• Daria Lukianchenko, Senior Lead Auditor
• Laurent Moreau, Business Development Manager

Moderator:

• Laurianne Kandalaft, Global Senior Marketing Manager