(AGENPARL) – SILVER SPRING mer 03 maggio 2023 The purpose of this guidance is to offer a systematic approach to quality risk management for better, more informed, and timely decisions. It serves as a foundation that is independent of, yet supports, other ICH Quality documents and complements existing quality practices, requirements, stand
Fonte/Source: http://www.fda.gov/regulatory-information/search-fda-guidance-documents/q9r1-quality-risk-management