Anthony M. Cundell is the director of microbiological development and statistics, Global Quality Technology, at Wyeth Pharmaceuticals, 401 N. Middletown Road, Pearl River, NY 10965-1299, tel. 845.602.2497, cundela@wyeth.com
FDA’s Guidance on Quality Metrics: Possible Implications for Contract Testing Laboratories
*This article is an opinion piece and does not necessarily represent the views of BioPharm International.
Microbial Testing in Support of Aseptic Processing
The role of microbial testing to ensure the sterility of aseptically filled sterile products is explained, from the product development phase to in-process monitoring to finished product testing.