Revalidation potency

To validate change in equipment, packaging, formulation operating procedure, or process that could impact product safety, efficacy, or potency. It is important to establish a revalidation program for critical equipment to maintain validity. 

There are various situations during the life cycle of a dissolution test that will require revalidation of the method. These are similar to those described for the potency assay in Chapter 2. 

There are no SOPs for determining the degree of testing necessary to assure the proper function of the system following any hardware or software modifications. There are no SOPs in place to periodically revalidate and challenge the software program to assure data acquired on the system are accurate and reliable for determining the purity and potency of products. 

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