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Cleaning Validation Glossary

Contamination Control Strategy (CCS)

Plan to prevent impurities

a Control Strategy is defined by PDA TR54, Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations as "A planned set of controls, derived from current product and process understanding, which ensures process performance and product quality. The controls can include parameters and attributes related to drug substance and drug product materials and components, facility and equipment operating conditions, in-process controls, finished product specifications, and the associated methods and frequency of monitoring and control.". This definition is applicable to Contamination Control Strategy (CCS) as it is a control strategy used to minimize risk and must be generated in compliance with good manufacturing procedures. A CCS outlines the potential sources of contamination from an action and assesses the current controls in place by the written procedures to determine if the level of risk is acceptable or if additional controls must be implemented. An example of an action is the charging of reactors, the possible contamination concern could be cross contamination from the charging process to nearby equipment. To control this risk, there is a written procedure requiring all other equipment to be sealed prior to a charging process. The CCS analyzed the severity, occurance, and detectability of cross contamination due to charging a reactor and concluded the procedures in place control the actions well enough to accept the risk.

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