This informal CPD article ‘What Inspectors Are Finding When CCS Falls Short’, was provided by Pharmalliance Consulting, who offer specialist support to pharmaceutical companies to maintain and increase quality compliance levels.
Introduction
Inspectors worldwide are paying close attention to how pharmaceutical companies implement their contamination control strategies. But while most facilities have a Contamination Control Strategy (CCS) in place, many are still getting cited for missing critical elements, especially when those strategies aren’t grounded in data or supported by real monitoring and validation.
Missing or Outdated Strategies
One of the most frequent issues has been a CCS that hasn’t been updated in years. In Europe, this is now a direct breach of Annex 1. Inspectors noted that some facilities hadn’t reviewed their CCS after major layout changes or equipment upgrades.
Another issue? Strategies that were too vague. For instance, some CCS documents said personnel were the highest contamination risk but included no concrete steps for reducing that risk or tracking performance.
Environmental Monitoring Gaps
In one U.S. inspection, the FDA found that a manufacturer failed to perform any air monitoring in ISO 5 aseptic filling areas. Surface monitoring was conducted only weekly, regardless of daily production, and isolated microorganisms were not routinely identified. The absence of active environmental monitoring in critical areas during operations was treated as a major GMP violation and cited as a critical issue in the agency’s warning letter.
Even when facilities had monitoring programs in place, inspectors often found that they weren’t linked back to the CCS. That made it hard to show how monitoring helped confirm the strategy was working.
Cleaning and Disinfection Concerns
FDA inspectors repeatedly flagged unvalidated cleaning methods. In one case, investigators discovered that a facility had never validated its cleaning process for critical equipment. The cleaning procedures lacked defined hold times, recovery data, and consistency checks. Without this, there was no assurance that microbial or chemical residues were being effectively removed between batches.
Some facilities also used disinfectants without verifying their effectiveness against environmental isolates. The expectation is now clear: validation of cleaning processes and disinfectants must be a part of the CCS, supported by data, and reviewed periodically.
Conclusion
A written CCS isn’t enough if it doesn’t match what’s happening on the ground. To avoid inspection issues, manufacturers need to ensure their contamination control strategy is based on real risk, backed by evidence, and consistently reviewed. When the CCS falls short, inspectors will notice and act.
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References:
U.S. Food and Drug Administration, 2023. Warning Letters Database, United States of America.
European Medicines Agency, 2023. The GDP Non-Compliance Reports of 2023 – An Overview, Mannheim, Germany.
International Society for Pharmaceutical Engineering, 2024. Pharma 4.0 and Annex 1 Implementation: A New Era for Aseptic Manufacturing, Maryland, United States of America.
