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自一九七七年第28届世界卫生大会以来,已有四、五十个国家和地区开始执行世界卫生组织(WHO)颁发的《药品生产和质量管理规范》(即GMP),有的还据此制订了本国的GMP或实施细则。虽然我国医药工业水平与工业发达国家相比,还存在较大的差距,然而根据国务院《关于加强医药管理的决定》和全面质量管理的要求,制订适合我国国情的GMP已是当务之急。于是,一九八○年中国医药工业公司组织上海医药工业公司和上海医药设计院着手起草,经过反复讨论,几易其稿,我国的《药品生产管理规范(试行稿)》已于一九八一年底正式定稿。为及时向我国医药行业介绍有关GMP的国内外概况,本刊从一九七六年起就陆续刊载了三十余篇这方面的文章。随着我国《药品生产管理规范(试行稿)》的试行,从事医药行业的技术人员,对实施GMP的技术尤为关注,为此本刊从这期起开辟“制药厂和GMP”专栏,以飨读者。“制药厂和GMP”将继续介绍涉及GMP范围的新型制药机械、微孔过滤技术、注射用水工艺、洁净技术等国内外情况,并结合国内药厂实际,发表体现GMP要求的工艺、设备、土建、自控及公用工程的设计方案,以助于老厂的改造和新厂的设计。同时,还将刊载有关GMP知识方面的讲座、工厂经验等。内容仍以普及、实用为主。“制药厂和GMP”专栏欢迎读者提出宝贵意见和建议,欢迎踊跃来稿。
Since the 28th World Health Assembly in 1977, four to fifty countries and regions have begun to implement the “Pharmaceutical Production and Quality Management Regulations” (namely, GMP) issued by the World Health Organization (WHO). Based on this, it has formulated its own GMP or implementation details. Although there is still a large gap between China’s pharmaceutical industry level and industrialized countries, according to the State Council’s “Decision on Strengthening Medicinal Management” and the requirements of total quality management, it is imperative to formulate GMP that suits China’s national conditions. As a result, in 1980, the Chinese Pharmaceutical Industry Corporation organized the Shanghai Pharmaceutical Industry Corporation and the Shanghai Pharmaceutical Design Institute to start drafting. After repeated discussions, several draft articles were drafted. The “Pharmaceutical Production Management Regulations (Trial Version)” was already in 1988. The official finalized at the end of the year. In order to introduce China’s pharmaceutical industry in a timely manner about the domestic and foreign GMP, we have published more than 30 articles in this journal since 1976. With the trial implementation of China’s “Pharmaceutical Production Management Regulations (Trial Version)”, technicians engaged in the pharmaceutical industry are particularly concerned about the implementation of GMP technology. For this reason, the journal has opened a “Pharmaceutical Plant and GMP” column for this purpose. reader. “Pharmaceuticals and GMP” will continue to introduce new pharmaceutical machinery, microfiltration technology, water injection technology, clean technology, etc. involving the scope of GMP. In conjunction with the actual situation of domestic pharmaceutical companies, they will publish processes, equipment and civil engineering that embody GMP requirements. , self-control and public works design programs to help the transformation of old factories and the design of new plants. At the same time, lectures and factory experience on GMP knowledge will be published. Content is still popular and practical. The “Pharmaceuticals and GMP” column welcomes readers to put forward valuable suggestions and suggestions. Welcome to contribute.