GMP in the QC Laboratory and Analytical Method Validation

Authors

Stephen Byrn, Purdue UniversityFollow
Zita Ekeocha, Purdue UniversityFollow
Martin Hynes, Purdue UniversityFollow
Roger Ongosi, Purdue UniversityFollow
Kari Clase, Purdue UniversityFollow

Funder Acknowledgement

This work was supported by the United States Pharmacopeia Promoting the Quality of Medicines Plus (PQM+) Program, grant # 15100109.

Abstract

This document aims to provide suggestions for course content to the team designing a GMP QC laboratory and analytical method validation course. This course is a 30-minute high-level overview that is part of the USP GMP course.

Recommended Citation

Byrn, Stephen; Ekeocha, Zita; Hynes, Martin; Ongosi, Roger; and Clase, Kari (2023) "GMP in the QC Laboratory and Analytical Method Validation," The Proceedings of the BIRS Community: Vol. 1 : Iss. 1, Article 7.
DOI: https://doi.org/10.7771/2836-5666.1003
Available at: https://docs.lib.purdue.edu/birstrp/vol1/iss1/7