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ICH (Final) Guidance: Q2(R2) Validation of Analytical Procedures and Q14 Analytical Procedure Development

Last week the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research, Office of Regulatory Policy, and the Center for Biologics Evaluation and Research announced the availability of final guidances for industry entitled “Q2(R2) Validation of Analytical Procedures” and “Q14 Analytical Procedure Development”.

These guidances replaces the draft guidance issued on August 29, 2022 on the "Q2(R2) Validation of Analytical Procedures" and the "Q14 Analytical Procedure Development.".

A general framework for the validation of analytical procedures is provided in the guidance entitled "Q2(R2) Validation of Analytical Procedures", which also outlines how spectroscopic data can be used in the validation process.

This guidance applies to analytical procedures used for release and stability testing of commercial drug substances and products.

The guidance is directed to common uses of analytical procedures, such as assay, potency, purity, impurity (quantitative or limit test), identity, or other quantitative or qualitative measurements.

'Q14 Analytical Procedure Development' provides harmonized guidance on scientific approaches for developing analytical procedures as well as principles for facilitating more efficient, science-based, and risk-based postapproval change management.

These guidance documents are intended to facilitate regulatory evaluations and allow for flexibility when managing changes to analytical procedures post-approval. The goal of development is to obtain an analytical procedure fit for the intended purpose: to measure an attribute or attributes of the material with the needed specificity/selectivity, accuracy, precision over the reportable range.

For more information and specific details click this link respectively  “Q2(R2) Validation of Analytical Procedures” and “Q14 Analytical Procedure Development”.


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