Drugs

2 ICH Guidances on Drug Analytical Procedures

FDA has made available two International Council for Harmonization draft guidances on drug analytical procedures.

A draft entitled Validation of Analytical Procedures Q2(R2) discusses the elements for consideration during the validation of analytical procedures included as part of regulatory submissions. It provides recommendations on how to derive and evaluate the various validation tests for each analytical procedure. It also includes a tabular summary of the characteristics applicable to common types of uses of analytical procedures, and a general discussion on how to perform validation studies for such procedures.

The other draft, Q14 Analytical Procedure Development, describes science- and risk-based approaches for developing and maintaining analytical procedures suitable for assessing the quality of drug substances and drug products. The document describes considerations for developing multivariate analytical procedures and for real time release testing. It also addresses principles to support change management of analytical procedures based on risk management, comprehensive understanding of the analytical procedure and adherence to predefined criteria for performance characteristics.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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