학술논문

Ongoing Analytical Procedure Performance Verification--Stage 3 of USP<1220>: Analytical procedure performance can be continually verified by risk-based monitoring of performance related data
Document Type
Report
Source
Pharmaceutical Technology. March, 2023, Vol. 47 Issue 3, p40, 5 p.
Subject
United States
Language
English
ISSN
1543-2521
Abstract
The principles of quality by design (QbD) and life cycle management, as outlined in International Council for Harmonisation (ICH) Q8-Q12, can equally be applied to the development, validation, and ongoing [...]