《FDAQC实验室检查指南》.doc

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). 1. INTRODUCTION The pharmaceutical quality control laboratory serves one of the most important functions in pharmaceutical production and control. 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 guide supplements other inspectional information contained in other agency inspectional guidance documents. For example, Compliance Program 7346.832 requiring pre-approval NDA/ANDA inspections contains general instructions to conduct product specific NDA/ANDA inspection audits to measure compliance with the applications and CGMP requirements. This includes pharmaceutical laboratories used for in-process and finished product testing. 2. OBJECTIVE The specific objective will be spelled out prior to the inspection. The laboratory inspection may be limited to specific issues, or the inspection may encompass a comprehensive evaluation of the laboratorys compliance with CGMPs. As a minimum, each pharmaceutical quality control laboratory should receive a comprehensive GMP evaluation each two years as part of the statutory inspection obligation. In general these inspections may include -- the specific methodology which will be used to test a new product -- a complete assessment of laboratorys conformance with GMPs -- a specific aspect of laboratory operations 3. INSPECTION PREPARATION FDA Inspection Guides are based on the team inspection approach and our inspection of a laboratory is consistent with this concept. As part of our effort to