PDA Letter Article

Build Your CCI Knowledge Base Through Data, Tech

by Jaime Cobo, WILCO AG


Recent regulatory and compendial updates emphasize the importance of gaining full knowledge about our manufacturing processes. The more information and knowledge we have about our processes and products, the more control tools might need to be introduced to achieve the expected quality of our products. The draft version of the EU Annex 1 revision emphasizes the use of quality risk management (QRM) principles to prevent microbial contamination in the final product. In other words, the collection of records/data from our processes is the way to gain more knowledge about our processes. Within this context, USP <1207> Sterile Product Packaging—Integrity Evaluation supports Annex 1 by describing and recommending the technologies to support container closure inspection purposes.