This informal CPD article ‘What a Good CCS Looks Like in 2025’, was provided by Pharmalliance Consulting, who offer specialist support to pharmaceutical companies to maintain and increase quality compliance levels.
It’s easy to say a Contamination Control Strategy (CCS) should cover all contamination risks, but what does that actually look like in practice? Inspectors are now sharing examples of what they consider strong, well-applied strategies. These cases give insight into what works and how manufacturers can improve.
Shared Ownership Makes a Difference
In companies where the CCS is working well, it’s rarely the responsibility of just one team. Instead, QA, Production, Engineering, and Microbiology all play a role. Some sites have a named CCS lead who keeps things moving and ensures updates happen when needed. This kind of ownership helps prevent the strategy from becoming stale or one-sided.
Training that Reinforces the Message
Some facilities are embedding the CCS into training, using it as a foundation for topics like gowning, aseptic behaviour, and cleaning. One company used real incident examples to bring the message home. Another created airflow visualisations to show operators how contamination can spread with simple mistakes.
These aren’t just good training practices, they’re a way to make the CCS relevant and memorable.
Showing Real Improvements
Inspectors also want to see how companies use the CCS to get better over time. That might mean upgrading equipment, adjusting workflows, or rethinking monitoring based on environmental trends. One company reviewed its CCS after a deviation investigation and decided to shorten campaign lengths and revise cleaning intervals. This kind of response shows maturity and a real commitment to controlling contamination.
Linking CCS to Environmental Data
Another marker of a good CCS is how well it responds to trends in environmental monitoring. Facilities that track microbial or particle trends over time, and feed those insights back into risk assessments, stand out. One company, after noting a gradual increase in viable counts in a Grade C zone, adjusted its disinfection routine and changed how materials were staged before entering the cleanroom. These small updates helped bring levels back down and showed inspectors that the CCS was not just a static policy but something used to guide real change.
Using the CCS in Change Control
A strong CCS also plays a role in change control decisions. Some companies are now asking how each change, whether it’s a new piece of equipment, a layout shift, or a revised gowning protocol, fits into the broader contamination picture. Inspectors have responded well to this approach, especially when they see the CCS referenced directly in change control documentation. It shows that contamination control isn’t just an afterthought but a key part of how decisions are made across departments.
Auditing the CCS Internally
Another area that sets strong strategies apart is internal auditing. Facilities with mature CCS programs are starting to include targeted CCS reviews as part of routine internal audits. Instead of only checking documentation, they walk the floor to verify that
practices align with what’s written. They also check whether recent changes have been incorporated into the CCS and if identified risks have been addressed. This kind of hands-on review helps keep the strategy aligned with reality and gives teams a chance to correct drift before inspectors point it out.
Conclusion
An effective CCS reflects how a facility thinks about risk and responds to it. The best strategies evolve, connect to training and data, and help teams make better decisions on the floor. When inspectors see that, they take notice.
We hope this article was helpful. For more information from Pharmalliance Consulting, please visit their CPD Member Directory page. Alternatively, you can go to CPD Industry Hubs for more articles, courses and events relevant to your Continuing Professional Development requirements.
References
International Society for Pharmaceutical Engineering, 2024. Pharma 4.0 and Annex 1 Implementation: A New Era for Aseptic Manufacturing, Maryland, United States of America.
Pharmaceutical Inspection Co-operation Scheme, 2023. 2023 Aide Memoire, Geneva, Switzerland.
