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ICH's updated Draft Guidelines on Analytical Method Development

Two draft guidelines were issued by the International Council for Harmonization (ICH) on 31 March 2022 (Thursday), intended to support ICH Q8 to Q12 Guidelines, as well as on-going ICH Q13.

This guideline presents a discussion of elements for consideration during the validation of analytical procedures included as part of registration applications submitted to the ICH member regulatory authorities.

Q2(R2) provides guidance and recommendations on how to derive and evaluate the various validation tests for each analytical procedure.

This guideline applies to new or revised analytical procedures used for the release and stability testing of commercial drug substances and products. The guideline is directed to the most common purposes of analytical procedures, such as assay/potency, purity, impurity (quantitative or limit test), identity, or other quantitative or qualitative measurements.

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 and describes the considerations for the development of multivariate analytical procedures and for real-time release testing (RTRT).

The new guideline is proposed to harmonise the scientific approaches to Analytical Procedure Development and to provide the principles relating to the description of the Analytical Procedure Development process.

This new guideline is intended to improve regulatory communication between industry and regulators and facilitate more efficient, sound scientific, and risk-based approval as well as post-approval change management of analytical procedures.

This guideline is intended to complement ICH Q2 Validation of Analytical Procedures

Public consultation dates:

EC, Europe - Deadline for comments by 31 July 2022


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