Revalidation pharmaceuticals process validation

Revalidation—At some point it may be necessary to revalidate all processes, equipment, and people. Life in the pharmaceutical world is a constantly changing situation. Some changes may be planned while others are not. For example, we may plan to change a mixer in a tank and we may implement the appropriate change control documentation that ensures that the change will be carefully evaluated and tested as to impact upon validated processes. 

In practice, the sheer nature of the dynamic validation process results in a substantiation of the original validation throughout the useful life of the method. As previously mentioned, a well-developed and-written method includes system suitability that must be met each time the method is performed. Additionally, the pharmaceutical industry has standardized on the need of formal method transfer exercises whenever an analytical method is to be performed by a different laboratory or in another facility. Also, change control procedures may require the revalidation of part or all of the method in the event of changes to the method, the process, or the formula of a drug product. The QAU should therefore have a system to formally monitor the... 

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