Redator Kivalita em 14 de March de 2024 em Legislation

FDA Publishes 2nd Revision of Q2 (R2) Analytical Procedure Validation and Q14 Analytical Procedure Development Guide

This month’s publication provides guidance on providing a general framework for the principles of validation of analytical procedures, including validation principles that cover the analytical use of spectroscopic data.

In addition, it provides harmonised guidance on scientific approaches to the development of analytical procedures and describes principles to facilitate more efficient, science-based and risk-based post-approval change management.

The new version replaces the one issued on August 29, 2022 and updates have been made under the International Council for Harmonization of Technical Requirements for Pharmaceutical Products for Human Use.

It is worth remembering that Anvisa has not promoted any update in relation to this, it only applies if there are direct indications in the legislation to follow the guide.

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