The revised EU GMP Annex 1 came into force in August 2023 and placed a single concept at the heart of sterile manufacturing: the Contamination Control Strategy (CCS). In many facilities the CCS is still treated as "a document to show during inspections". Inspectors, however, now look less at the document itself and more at how the strategy is reflected in decisions on the floor.
The CCS should link facility design, personnel, materials, equipment, cleaning, environmental monitoring and process controls under a single risk logic. It must be clear which contamination risk each control measure addresses.
Instead of writing from scratch, first list your existing controls: which SOP, which monitoring programme and which validation study controls which risk? This inventory quickly reveals gaps and unnecessary duplication.
Quality Risk Management (ICH Q9) work should be done with production and engineering teams, not at a desk. Personnel and material flows, intervention points and critical operations should be observed on site.
Sampling points, frequencies and alert/action limits must be justified and based on the risk assessment in the CCS. Trend analyses should be reviewed periodically.
Aseptic behaviour, gowning qualification and participation in process simulations (media fills) are among the most critical links of the CCS. Training records and behaviour on the floor must be consistent.
Annex 1 explicitly encourages barrier technologies such as RABS and isolators, as well as automation. A decision to continue with existing technology should also be backed by a justified risk assessment.
Deviations, change controls, environmental monitoring trends and audit findings should feed the CCS regularly. Periodic review dates and owners must be clearly defined.
A CCS that works on the floor is the easiest document to defend during an inspection. If you would like to assess your current situation together, please get in touch.
Our team is ready to plan a solution that fits your reality on the shop floor.