Module 3 2019

Validation / Procedure Types

• “The Objective of validation of an analytical procedure is to demonstrate that it is suitable for its intended purpose” 1

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Validation proves the “ fitness for purpose ” of a method

• Therefore to determine the validation you need, first define the purpose of the method Examples: 1. Release of the first batches of API for toxicology 2. Release of the first materials (API & Product) for human use 3. Release and testing of batches (API & Product) for registration stability 4. Methods for tech transfer and Filing (same methods as (3) hopefully) • Each having a different purpose so differing validation may be appropriate

1 ICH Topic Q2 (R1) Validation of Analytical Procedures: Text and Methodology

The Organisation for Professionals in Regulatory Affairs