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.
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