Guide to Inspections of Foreign Pharmaceutical Manufacturers

机译：外国制药企业检验指南

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The guide is a update to the Guide to Inspections of Foreign PharmaceuticalManufacturing Plants that originally issued September 1992. The purpose of the guide is to address logistical and technical aspects specific to drug inspections. It is not intended to provide guidance on how to perform an inspection at a foreign drug establishment. Topics covered in the guide include: the overall program administration and management of this component of the foreign inspection progam, documents to be reviewed by the inspection team prior to a trip and at the firm, the communication and the flow of work among Agency offices, and a reference list that is applicable to pharmaceutical manufacturing.

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年度 1996
页码 p.1-11
总页数 11
原文格式 PDF
正文语种 eng
中图分类工业技术;
关键词
Pharmaceutical manufacturers; Inspections; Foreign countries; Guidelines; Regulations;

机译：制药厂商;检验;外国;指南;法规;

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Guide to Inspections of Foreign Pharmaceutical Manufacturers

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