FDA制剂厂检查指南.docVIP

GUIDE TO INSPECTIONS OF DOSAGE FORM DRUG MANUFACTURER S ? CGMPR S Note: This documcnt is reference material for invcstigators 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 This document is intended to be a general guide to inspections of drug manufacturers to determine their complianee with the drug CGMPR s. This guide should be used with in struct! ons in the I0M, other drug inspcction guides, and compliance programs. A list of the inspection guides is referenced in Chapter 10