Analytical Method Validation

In pharmaceutical industries, the validation of analytical methods is used to demonstrate that the method is fitted for its purpose; it must follow a plan which includes scope, performance characteristics, and acceptance limits. Analytical methods need to be validated or revalidated prior to their introduction into routine analyses (release of batch). The overarching philosophy in current good manufacturing practices (cGMPs) of the twenty first century and robust modern quality systems is the quality that it has to be built into the product, and testing alone cannot be relied to ensure the quality of the product. From the analytical perspective, it will mean that analytical methods used to test products should have quality attributes built into them. In order to apply quality attributes into the analytical method, fundamental quality attributes have to be applied by the bench level scientist. This is a paradigm shift that requires the bench level scientist to have a scientific and technical understanding, product knowledge, process knowledge, and/or risk assessment ability to appropriately execute the quality functions of analytical method validation. In addition, it requires the following procedures: (a) an appropriate training of the bench level scientist to understand the principles involved with method validation, validate an analytical method, and understand the principles involved with the method validation, (b) proper documentation and understanding and interpreting data, and (c) cross – an understanding functional of the effect of their activities on the product and to customers (the patient). Management has a responsibility of verifying that gained skills from the training are implemented in routine analyses performance. This chapter gives a review and strategy for the validation of analytical methods in-house, recommendation in documentation and completion of method validation in the pharmaceutical environmental.