Module 3 2019

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

* R2 is coming – validation principles covering spectroscopic and spectrometric data * Q14 Analytical Procedure Development Guideline being discussed

The Organisation for Professionals in Regulatory Affairs