If you have been wondering why there has been so much buzz recently about contamination control strategies (CCSs), or if you want to brush-up on your CCS fundamentals, Pharmaceutical Online’s “All You Need to Know about Contamination Control Strategies” is for you. This two-part article series (see links below) provides a deep-dive discussion led by pharmaceutical microbiology experts Becky Brewer, Vanessa Figueroa, and Greg Gibb, who have a combined 60-plus years of experience in the pharmaceutical Industry.
Regarding the recent buzz, it began when the topic of contamination control strategy was formalized in a very specific, technical way with the 2022 release of EU GMP Annex 1, Manufacture of Sterile Medicinal Products. The concept of a control strategy for preventing contamination is not new, though, and has been in place for decades, with some companies organizing their efforts into a well-structured document, while others may have assessed the potential for contamination in a less consolidated way through individual systems or processes. At QxP, we have been working for years to support clients in the development of microbial control strategies, and so to see the development of a CCS now required in a formal way by Annex 1 is very encouraging and we hope to see more companies adopting a strategic approach.
Here are the links to Parts 1 and 2 of the series:
All You Need to Know About Contamination Control Strategies, Part 1
All You Need to Know About Contamination Control Strategies, Part 2
If you have any follow-up questions, please reach out to Vanessa Figueroa, QxP Executive Director Microbiology and Sterility Assurance, on LinkedIn: https://www.linkedin.com/in/vvfscience/
