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医院生产的制剂虽然只能是对市场的补充,满足临床和科研的需要,但直接为求医患者使用,其质量的优劣直接影响病人的健康和安危,故制剂的生产必须在全过程规范化的条件下进行。为引起卫生行政部门及医院药学人员关注制剂质量的提高,并将制剂生产的管理工作推上规范化、科学化管理的轨道,笔者就医院制剂生产推行并实施GMP的必要性及方法谈一些浅见。 一、医院制剂室推行、实施GMP的必要性 1.我国卫生部根据《药品管理法》第九条规定,于1988年3月颁布了《药品生产质量管理规范》(简称:GMP),作为药品生产企业管理生产和质量的基本准则要求执行,以期在生产全过程中,保证生产出优质的药品。医院制剂室是生产多
Although the preparation of hospital products can only be added to the market to meet the needs of clinical and scientific research, but for patients seeking medical treatment directly, the quality of its direct impact on the quality of patients’ health and safety, the preparation of the production must be standardized throughout the process Under the conditions of. In order to arouse the health administrative department and hospital pharmacy personnel to pay attention to the improvement of preparation quality and put the management of preparation production on the track of standardization and scientific management, the author makes some humble opinions on the necessity and method of implementation and implementation of GMP in hospital preparation production. I. The Necessity of Implementing GMP in Hospital Preparatory Rooms 1. According to Article 9 of the Drug Administration Law, the Ministry of Health of China promulgated the “Code of Practice for the Quality Control of Pharmaceutical Production” (abbreviation: GMP) in March 1988 as a pharmaceutical The basic rules governing the production and quality of manufacturing enterprises are required to be implemented with a view to ensuring the production of quality medicines during the entire production process. Hospital preparation room is to produce more