top of page

All Posts


Writing a Contamination Control Policy for Sterile Manufacturing
Contamination control and aseptic processing are at the heart of producing safe, effective, and sterile pharmaceutical products—especially in sterile manufacturing. With the latest updates to EU Annex 1 and guidance like PDA Technical Report 90, there’s a clear shift toward a more holistic, science- and risk-based approach. Rather than relying on isolated controls, the expectation now is to build an integrated Contamination Control Strategy (CCS) that connects facility design
William N
2 days ago4 min read
bottom of page