Template method validation plan impurity tests

Written by Dr. Janet Thode on . Posted in Method validation

In the highly regulated pharmaceutical environment, documentation is always associated with a little more effort... This also applies to the creation of necessary documents required for laboratory methods. Before an analytical method is allowed to be used in a QC laboratory for the first time, it prior must be validated.

And to perform method validation, you need a plan that describes everything you have to do. For this reason, we’d like to make your life easier by providing a template of a method validation plan for an impurity test today.

 

Template method validation plan impurities

 

Further templates for identification methods as well as content and potency determinations (summarized as assays) can be found here.

Tags: method validation purity validation plan template

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