A Contamination Control Strategy (CCS) outlines a means of identifying and analyzing risk, reviewing mitigating innovations and opportunities, and ultimately defining preventive and corrective action ...

One of the main goals of pharmaceutical regulatory rules is to keep environmental contamination at a minimum. According to the EU GMP Annex 1 regulatory standard for sterile drug products, a ...

Bio: Don Singer is a Fellow in the American Society for Quality and formerly a GSK Senior Fellow. Don has been Chair of the USP General Chapters - Microbiology Committee of Experts and a member since ...

Advancing microbiology QC in biomanufacturing requires new technologies, strong cross-functional practices, and collaboration ...