Tuesday, December 14, 2010

Validation Process in Pharmaceutical Industry

Validation is a method to keep a check on the specific process, whether the ongoing process is able to meet the desired requirements. The definition of Validation as given by GMP is  "Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.”

Validation documentation includes analytical information, reports determining development, formulae which are used in the manufacturing process, standard operating procedures, development reports. Documentation also provides with the information for the currently running process. Activities performed under Validation will incorporate a level of Impact Assessment to ensure that systems, services and products directly influenced by the testing have been identified.

Validation process is conducted in various ways, some of them are:

Prospective validation
Under this kind of validation, a documented evidence is made defining, that a process will do, what it is supposed to do. And this specification is based upon a pre planned series of scientific tests as defined in the validation plan.

Concurrent validation
This kind of validation comes in a picture when an existing process is in a state of control because of various tests applied on samples throughout a process and when, same can be shown. For the documentation to be presented, all data is collected with the proper implementation of the process. Moreover, collecting of data continuous till sufficient information is available to demonstrate process reproducibility.

Retrospective validation
Finally Retrospective validation is documented, which is actually based on review and analysis of historical data. This particular validation defines, that a process does what it purports to do

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