ICH Q14 Analytical procedure development - Scientific guideline

This guideline describes science and risk-based approaches for developing and maintaining analytical procedures suitable for the assessment of the quality of drug substances and drug products. It applies to new or revised analytical procedures used for release and stability testing of commercial drug substances and products (chemical and biological/biotechnological). The guideline can also be applied to other analytical procedures used as part of the control strategy following a risk-based approach.

Keywords: development of analytical procedures, robustness, parameter ranges, analytical procedure control strategy, lifecycle management, multivariate analytical procedures, real time release testing

Current version - effective from 14/06/2024

ICH Q14 Guideline on analytical procedure development - Step 5

Adopted Reference Number: EMA/CHMP/ICH/195040/2022

Document history

Overview of comments received on ICH guideline Q14 on analytical procedure development (EMA/CHMP/ICH/195040/2022)

Reference Number: EMA/690538/2022

ICH guideline Q14 on analytical procedure development - Step 2b

Draft: consultation closed Consultation dates: 31/03/2022 to 31/07/2022 Reference Number: EMA/CHMP/ICH/195040/2022