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A Cost-Effective Approach to Cleaning Validation and Verification 1 A Cost-Effective Approach to Cleaning Validation and Verification Alexander Wellems, Director – Manufacturing, Ropack Pharma Solutions A fullservice contract manufacturing organization (CMO) encounters many compounds at different phases of development and varying customer requirements. From fully developed large scale manufacturing to a single development batch, the CMO must be prepared to handle multiple compounds in the same facility. One extremely important requirement is ensuring that the established cleaning procedures remove all residual Active Pharmaceutical Ingredient (API) from all productcontact equipment parts utilized during manufacturing so that there is no risk of crosscontamination. The FDA clearly outlines its expectations within the “Validation of Cleaning Processes” under Inspections Guides. To satisfy the enumerated expectations, there can be many different approaches to cleaning verification and/or validation, and the CMO must determine the most efficient, costeffective and practical approach. In a CMO setting, a standard threebatch validation approach may not be the most practical as there may not be three sequential batches being manufactured at one time. Additionally, a verification following each manufactured batch could be considered as it would be sufficient to ensure no residual API, or detergent. However, this is not the most cost effective approach as this approach would result in a large amount of sample analysis and obvious increases to laboratory costs. A riskbased approach using a worstcase scenario is the most appropriate for a CMO. By using a known compound with low solubility and low potency on the highestrisk equipment and equipment locations, a validation protocol can be developed to ensure
