Validation and Qualification Approach Outlined in New Annex 1 Revision
In August 2022, a new EU GMP Volume 4 Annex 1 revision was issued, proposing new regulations for sterile drug products and production. This 2022 release replaces the most recent draft from 2020 and the existing 2008 revision. The updated revision further emphasizes validation and qualification topics. In the new, longer Annex 1, (composed of 59 pages instead of the 16 of the previous version) better detail about specific needs and requirements for premises, equipment, utilities, and personnel are described to provide guidance for the manufacturing of sterile products.
Some of the principles and guidance, such as contamination control strategy, design of premises, cleanroom classification, qualification, validation, monitoring, and personnel gowning, may be used to support the manufacturing of other products that are not intended to be sterile; the control and reduction of microbial, particulate, and endotoxin/pyrogen contamination is considered important in these non-sterile applications.
In this paper, the following topics are discussed:
-new regulations surrounding validation and qualification
-definitions of validation and qualification
-the importance of validation and qualification
-how PMS can help with these processes
