1. Ongoing Analytical Procedure Performance Verification--Stage 3 of USP<1220>.
- Author
-
Borman, Phil, Mahr, Amanda Guiraldelli, Weitzel, Jane, Thompson, Sarah, Ermer, Joachim, Sproule, Stephanie, Roussel, Jean-Marc, Marach, Jaime, and Pappa, Horacio
- Subjects
CLINICAL pathology ,ION exchange chromatography ,PHARMACEUTICAL technology ,CALIBRATION ,ACCURACY ,MEDICAL protocols ,RISK assessment ,QUALITY control ,QUALITY assurance ,MEDICAL prescriptions ,STANDARDS - Abstract
The article discusses the ongoing verification of analytical procedures and the principles of quality by design (QbD) and life cycle management. It focuses on the recently published United States Pharmacopeia (USP) and International Council for Harmonisation (ICH). It explains the three-stage approach to ensuring that the analytical procedure is fit for purpose across the entirety of its life cycle, including the analytical target profile (ATP) concept.
- Published
- 2023