> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# ICH Analytical Procedure Development Guidance
- URL: https://www.fdaweb.com/ich-analytical-procedure-development-guidance/
- Published: 2024-03-06T12:00:00.000Z
- Updated: 2026-09-14T14:24:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156492

FDA has published the International Council for Harmonization (ICH) guidance, *Q14* *Analytical Procedure Development*, describing science and risk-based approaches for developing and maintaining analytical procedures suitable for evaluating the quality of drug substances and drug products. The [document](https://www.fda.gov/media/161202/download?ref=fdaweb.com) says that the systematic approach suggested in other ICH guidances can also be applied to the development and life cycle management of analytical procedures.

“When developing an analytical procedure,” it says, “a minimal (also known as traditional) approach or elements of an enhanced approach can be applied.”

The guidance says it applies to analytical procedures used for release and stability testing of commercial drug substances and products, referred to as products. It can also be applied to other analytical procedures used as part of the control strategy following a risk-based approach. The scientific principles described in the guidance can be applied in a phase-appropriate manner to analytical procedures used during clinical development.

The guidance contains an Introduction, General Considerations for Analytical Procedures, Analytical Target Profile, Knowledge and Risk Management in Analytical Procedure Development and Continual Improvement, Evaluation of Robustness and Parameter Ranges of Analytical Procedures, Analytical Procedure Control Strategy, Life Cycle Management and Postapproval Changes of Analytical Procedures, Development of Multivariate Analytical Procedures: Additional Considerations, Development of Analytical Procedures for Real Time Release Testing: Additional Considerations, Submission of Analytical Procedure-Related Information, Glossary, References, and an Appendix.