FDA制剂生产厂检查指南.docxVIP

Dosage Form Drug Manufacturers cGMPs (10/93) FDA 制剂生产厂检查指南 GUIDE TO INSPECTIONS OF DOSAGE FORM DRUG MANUFACTURERS - CGMPRS 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). 注：此指南是FDA检查官和其工作人员的参考资料。此文件不约束 FDA，也不 赋予任何人任何权利，特权，利益或豁免权。 I. 简介 This document is intended to be a general guide to inspections of drug manufacturers to determine their compliance with the drug CGMPRs. This guide should be used with instructions in the IOM, other drug inspection guides, and compliance programs. A list of the inspection guides is referenced in Chapter 10 of the IOM. Some of these guides are: 该文件旨在为检查药品生产厂家提供一个总体性的指导， 以决定他们是否符合药 物生产的 cGMP 法规。该指南应该与 IOM(Investigations Operations Manual，即 检查操作手册 )，其他的药品检查指南，及法规符合性程序中的指导一起使用。 在 IOM 的第十章中提供了一个检查指南清单，其中有： o Guide to Inspections of Bulk Pharmaceutical Chemicals. o原料药检查指南 o Guide to Inspections of High Purity Water Systems. o高纯水系统检查指南 o Guide to Inspections of Pharmaceutical Quality Control Laboratories. o 药品 QC 实验室检查指南 o Guide to Inspections of Microbiological Pharmaceutical Quality Control Laboratories. o微生物药品QC实验室检查指南 o Guide to Inspections of Lyophilization of Parenterals. o 冻干注射剂检查指南 o Guide to In specti ons of Validati on of Clea ning Processes. o清洁验证检查指南 o Guide to In specti ons of Computerized Systems in Drug Process ing. o制药过程中的计算机化系统检查指南 o Guideline on General Principles of Process Validation. o工艺验证总体原则指南 II. CURRENT GOOD MANUFACTURING PRACTICE REGULATIONS II. CGMP Prescriptio n vs. Non-prescripti on 处方药和非处方药 All drugs must be manu factured in accorda nee with the curre nt good manu facturi ng practice regulations otherwise they are considered to be adulterated within the meaning of the FDC act, Section 501(a)(2)(B). Records relating to prescription drugs must be readily available for review in accorda nce with Sec. 704(a)(1)(B) of the FDC Act. If the product is an OTC dru