Cleaning Validation

A master plan is the basis of the cleaning validation program, which describes the overall approach of cleaning validation. This includes the matrixing philosophy involved and the rationale associated thereto. Once the products and pieces of equipment are identified for use in the validation study, trials may start.

Some worst-case scenarios may also be considered to challenge the cleaning procedure, for example, having the product dried on the surface to make the cleaning difficult or applying the effect of weekends and holidays on the cleaning schedule, and so on.

A brief review of the activities to establish a comprehensive cleaning validation program is given below.

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