Revised EU GMP Annex 1 requirements must be fulfilled by August 2023. Designed to protect and increase confidence in the sterility of these products, the new specifications are significant and wide-ranging, spanning the Quality system and the manufacturing process itself. Anna Cluet of Rephine discusses the practical specifics of designing and delivering a fit-for-purpose contamination control strategy.
For pharmaceutical and medical device manufacturers, computerized systems validation is vital. The following are three areas businesses must fine tune to ensure computerized labeling systems meet the stipulations of the new GxP regulations.
Make sure your 510(k) submissions pass with flying colors. Explore the latest regulations impacting bacterial endotoxin testing.
Drop the checkbox mentality and embrace accountability and understanding.
If an organization is familiar with the challenges associated with complying with the regulatory requirements associated with a Class III device under the MDD, understanding and complying with Annex IV of the IVDD should be a proverbial “cakewalk,” then again, maybe not.