Q2(R2) Validation of Analytical Procedures and Q14 Analytical Procedure Development; International Council for Harmonisation; Guidances for Industry; Availability
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The Food and Drug Administration (FDA or Agency) is announcing the availability of final guidances for industry entitled "Q2(R2) Validation of Analytical Procedures" and "Q14 Analytical Procedure Development." The guidances were prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance entitled "Q2(R2) Validation of Analytical Procedures" provides a general framework for the principles of analytical procedure validation, including validation principles that cover the analytical use of spectroscopic data. The guidance entitled "Q14 Analytical Procedure Development" provides harmonized guidance on scientific approaches for analytical procedure development and describes principles to facilitate more efficient, science-based, and risk-based postapproval change management. The guidances are intended to facilitate regulatory evaluations and potential flexibility in postapproval change management of analytical procedures when scientifically justified. The guidances replace the draft guidances "Q2(R2) Validation of Analytical Procedures" and" Q14 Analytical Procedure Development" issued on August 29, 2022.
Abstract as published in the Federal Register.
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