What is your GMP Cleanroom Contamination Control Strategy (CCS)?
Imagine a scenario where your organisation is gearing up for a regulatory audit and you have been tasked with supporting their preparation of a Cleanroom Contamination Control Strategy (CCS).
The CCS outlines the key decisions and scientific rationales for contamination control, and is based on a detailed understanding of the process, contamination risks/hazards and contamination source strengths, i.e. the application of QRM. The CCS is focused on where the product or process is exposed and at risk, critical control points (CCPs) and mitigation controls, applying the best available technologies and in an integrated and holistic manner. The CCS will address all aspects of the control measures, (Physical, Organisational and Procedural) under the following fundamental categories:
There are many views of what a CCS should look like. It could be a separate document file, like a Site Master File (SMF) OR Quality Management System (QMS), while others take the view that the CCS is a high-level document, is not expected to be a Bible but does reference other parts of the SMF and QMS, thereby avoiding unnecessary duplication. It is important to demonstrate to the auditor that you understand the critical quality attributes (CQAs), the critical process parameters (CPPs), the critical control points (CCPs) in the environment, the hazards at each risk, the consequences and what we need to do to protect our patient.
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Engineering Controls
• People and Material controls, Gowning and Behaviour • Ongoing Cleaning & Disinfection
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