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Quo Vadis Analytical Procedure Development and Validation?

Authors :
Burgess, C.
McDowall, R. D.
Source :
LC-GC Europe. Jul/Aug2022, Vol. 35 Issue 7, p279-284. 6p.
Publication Year :
2022

Abstract

What do the draft publications ICH Q2(R2) and Q14 for analytical procedure validation and development mean for a regulated good manufacturing practice (GMP) laboratory? Are they consistent with the approach taken by the United States Pharmacopeia (USP) <1220> on Analytical Procedure Life Cycle? Why does it take the ICH two documents to describe what the USP can do in one? [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
14716577
Volume :
35
Issue :
7
Database :
Academic Search Index
Journal :
LC-GC Europe
Publication Type :
Academic Journal
Accession number :
158305390
Full Text :
https://doi.org/10.56530/lcgc.eu.ue1079n4