From the announcement:
"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."
It is expected to be used in conjunction with ICH Q2(R2) Validation of Analytical Procedures, which "provides a general framework for the principles of analytical procedure validation, including validation principles that cover the analytical use of spectroscopic data."
A link to the final guidance and how to submit comments to the docket: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q14-analytical-procedure-development
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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