Application note: Analytical methods in cleaning validation

A typical cleaning validation (CV) programme consists of three phases: Design, Validation and Continued Verification.

A key industry challenge is how to select the most appropriate analytical method(s) for evaluating known and potential residues throughout the different phases of a CV programme.

For example, in early design-phase work, adequate information on the cleanability of the worst-case compounds or their degradants may not be known. This may create challenges in developing product-specific analytical methods as these tests assume that all potential interferences are known. Similarly, in the validation phase, product-specific analytical methods may be less useful as common residuals may include uncharacterized degradants or more difficult to clean compounds rather than a target API. Lastly in the continued verification phase, manufacturing concerns including product changeover, equipment turnover, cost, and a desire for continuous or automated monitoring may influence the methods used.