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《药品生产质量管理规范》(以下简称《规范》)是根据《中华人民共和国药品管理法》的规定,由国务院卫生行政部门制定颁发,现将《规范》的形成,内容和实施问题作一概述.一 形成背景、依据、过程1.背景:GMP(英文原名Good Manu-facture Practice for Drugs,简称GMP),是在药品生产全过程中,保证生产出优质药品的管理制度.1969年第22届世界卫生大会,世界卫生组织建议各成员国的药品生产采用GMP制度,以确保药品质量和参加“国际贸易中药品质量签证体制”.世界卫生组织提出
The “Code of Practice for the Quality Control of Pharmaceutical Production” (hereinafter referred to as the “Code”) is formulated and promulgated by the health administrative department under the State Council according to the provisions of the “Drug Administration Law of the People’s Republic of China”. Now, the formation, content and implementation of the “Regulation” are summarized I. Background, Basis, Process 1. Background: GMP (Good Manu-facture Practice for Drugs, GMP for short) is a management system that ensures the production of quality medicines in the whole process of drug production. The 22nd World Health Assembly, the World Health Organization recommends that member states drug production using the GMP system to ensure the quality of medicines and participate in the “quality system of medicines in international trade visa system.” World Health Organization