FDA - Final Guideline: Q14 Analytical Procedure Development AND Q2(R2) Validation of Analytical Procedures

13th March 2024

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 harmonised guidance on scientific approaches for analytical procedure development and describes principles to facilitate more efficient, science-based, and risk-based post approval change management. 

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