The 2022 revision of EU GMP Annex 1 puts the contamination control strategy at the centre of sterile manufacturing. Sites are expected to identify contamination hazards across the facility and process, define the controls that address them, monitor those controls and periodically review whether they are effective. Many sites keep the CCS as a long Word document, which makes it hard to show what changed, who approved it and which version applied at a given time.
What Swat iQua Suite gives you
In Swat iQua Suite the CCS is a controlled record. Each site has its CCS, and you can scope a CCS to a specific product version where the product needs its own strategy. The element register captures each hazard with its control, monitoring and effectiveness measure. The register can be edited while the CCS is in Draft. Approval is a segregated duty — the approver cannot be the author — and is e-signed. When a revised CCS for the same site and scope is approved, the previous one is superseded automatically, and every change is in the audit trail.
Alongside your sterile controls
The CCS sets out the strategy; the controls it describes are run in other parts of the sterile platform. Environmental monitoring, gowning qualification and cleanroom readiness are managed in Environmental Monitoring. Utility limits and results sit in Utilities Monitoring. Media fills keep each aseptic line qualified, and sterilisation cycles and filter tests are released by QA. Together they cover the Annex 1 controls that a CCS typically refers to, in one platform with one audit trail.
The CCS module is a versioned document and register. Monitoring results stay in their own modules, where they are reviewed and trended.