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我国从1992年颁布了《药品生产质量管理规范》(简称GMP)以来,GMP已逐步为药品生产企业及医院制剂单位所认识、接受并实施,尤其是1995年后,我国决定实施药品GMP认证制度,并且按剂型分类,分阶段限期推行《药品生产质量管理规范》,限期过后仍达不到要求的企业将停产。对于医院制剂,2000年国家药品监督管理局也颁布了《医疗机构制剂许可证验收标准》(以下简称93条)。并于2001年7月1日贯彻执行。
Since China promulgated the “Code of Practice for the Quality Control of Pharmaceutical Production” (referred to as GMP for short) in 1992, GMP has been gradually recognized, accepted and implemented by pharmaceutical manufacturing enterprises and hospital preparation units. Especially after 1995, China has decided to implement the drug GMP certification system , And according to the dosage form classification, phased implementation of “pharmaceutical manufacturing quality management standards”, after the deadline will still not meet the requirements of the company will be discontinued. For hospital preparations, the State Drug Administration in 2000 also promulgated the “Acceptance Criteria for Preparation License of Medical Institutions” (hereinafter referred to as 93). And in July 1, 2001 implementation.