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Quo Vadis Analytical Procedure Development and Validation?
- 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]
- Subjects :
- *CURRENT good manufacturing practices
Subjects
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