Ensuring an Effective Contamination Control Strategy

TAKEAWAY

If you are building or refining your contamination control strategy, this report shows you how to structure a science- and risk-based CCS that connects facility, equipment, utilities, consumables, and monitoring into one coherent concept.

ARTICLE AT A GLANCE

PDA Technical Report No. 90 provides a practical framework for developing, implementing, and maintaining a holistic contamination control strategy across sterile manufacturing, from CCS foundations and risk assessment through to validation, monitoring, and continual improvement. It explains how to define CCS objectives, map contamination risks across the manufacturing process, and assign appropriate preventive and detective controls to each barrier, including single-use systems, filtration, and packaging. The report offers templates and examples that help you document your CCS in a way that is transparent for regulators and aligns with current EU GMP Annex 1 expectations.

LINK

https://www.pda.org/pda-letter-portal/home/full-article/how-to-establish-effective-ccs-with-tr-90