“Product and Process Validation.
Principles, Practices & Implementation”.
… validation versus verification, validation gap analysis, DQ, IQ, OQ, PQ, equipment validation, validation master plan, protocol reporting…
Validation provides documented evidence that a product or process meets pre-defined specifications, is fit for purpose, i.e. meets quality, reliability & customer requirements. Implementing an efficient validation process need not be difficult, provided there is a clear understanding by all involved on how to implement such a process.
In planning a product and process validation, a common approach is to create a top level Validation Master Plan, from which the review, approval & implementation process for the various protocols and test activities can be clearly controlled. For smaller once off validations, single validation documents will suffice.
When implementing a validation process, you will need to consider if verification will suffice or is validation absolutely necessary and where will you focus your validation efforts, i.e. you will need to integrate risk assessment into your validation planning.
You may need to perform a validation gap analysis. When implementing product and process validation, you will need to consider what test qualifications you will be performing, i.e. design qualification, installation qualification, operational qualification, equipment qualification, a pre-validation study, process qualification. Is software part of your product or process? If yes, you may need to perform a software validation.
Associated with a compliant validation process will be a need to ensure that there are suitable documentation controls in place. The control of documentation applies to the various validation specific documents, e.g. test protocols and protocol reports, in addition to routine documentation such as test procedures, operating procedures, equipment specifications, bills of materials, calibration records, etc.
Aligned to documentation management will be defined and effective change control processes.
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