Module 3 Presentations

07/05/2024

Validation / Procedure Types

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

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Regulatory Environment

Much regulatory guidance exists Vital ● ICH Q2(R1)*, Q3A(R2), Q3B(R2), Q3C(R6), Q3D, Q6A, Q6B, Important ● FDA Guidance for Industry -Analytical Procedures & Method Validation for Drugs and Biologics (July 2015) ● FDA Reviewer Guidance – Validation of Chromatographic Methods ● IUPAC –Harmonised Guidelines for Single-Laboratory Validation of Methods of Analysis * Q2 R2 effective June 2024– validation principles covering spectroscopic and spectrometric data * Q14 effective June 2024 -Analytical Procedure Development Guideline being discussed

The Organisation for Professionals in Regulatory Affairs

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