FDA关于QC检查的指南.docVIP

GUIDE TO INSPECTIONS OF PHARMACEUTICAL QUALITY CONTROL LABORATORIES Note: This document is reference material for investigators and other FDA personnel? The document does not bind FDA, and does no confer any rights, privileges, benefits, or immunities for or on any person (s)? INTRODUCTION The pharmaceutical quality control laboratory serves one of the most important functions in pharmaceutical production and contro 1. A significant portion of the CGMP regulations (21 CFR 211) pertain to the quality control laboratory and product testing? Similar concepts apply to bulk drugs. This inspection g