Regulatory bodies expect that pharmaceutical companies have a Contamination Control Strategy (CCS) in place that outlines the control of contamination of utilities, manufacturing systems and environment and ultimately the pharmaceutical product itself. Patrick Nieuwenhuizen at Pharmalex explains more about contamination control strategy.
Contamination Control Strategy
Regulatory bodies expect that pharmaceutical companies have a Contamination Control Strategy (CCS) in place that outlines the control of contamination of utilities, manufacturing systems and environment and ultimately the pharmaceutical product itself. The question is what are the key elements to be considered in order to meet the quality system requirements detailed in ICHQ10 in addition to ICHQ9 and EudraLex Volume 4 Annex 1 for a CCS? What points need to be considered to support the implementation of such a program within any manufacturing facility? What makes it robust? Should it be multifaceted to ensure its effectiveness?
These are all valid questions and key to ensure your CCS is robust. One important facet is that the strategy is to be built on a risk-based foundation. From the start, it requires a multidisciplinary team with a good understanding of the process, the utilities and equipment that serve the process. Cross-functional expertise allows scientific justified assessments to be made of potential microbiological, particulate, chemical and cross-product risk to your product. A solid CCS also provides an estimation for the likelihood of a risk occurring and severity of the impact to the patient if the risk occurred. This allows you to identify the key areas of focus in the CCS and provides rationale for implementation of control or detection measures.
Development of a robust plan is critical in all manufacturing facilities – aseptic, terminal sterilisation and non-sterile. This is not futility as pharmaceutical manufacturing generally comprises a complex, multi-step processing system in which significant risks from various types of contamination are presented by different sources. Clear regulatory guidance is available on the need for exclusion and control of contamination at all stages during manufacture, however, addressing contamination control in a non-sterile manufacturing environment is less clear cut. Under all circumstances, good knowledge of your own process is paramount.
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