《首都医药》1999年第8期第9页刊登了《药品生产批号应规范统一》一文。文中指出:“近年来药品批号管理主要存在以下两个问题:1.药品生产批号编制方法不统一。2.企业对批号的印注不规范。”诚然,在实际工作中,药品批号确是药品质量管理中的主要项目,但笔者对该文所述观点不尽认同。 讨论药品的批号问题,我们必须首先明确药品“批”的概念。国家药品监督管理局98年颁布的《药品生产质量管理规范》(GMP)第69条对“批”作了明确规定,即:“在规定限度内具有同一性质和质量,并在同一生产周 “Capital Medical” 1999 the eighth period page 9 published a “drug production batch number should be standardized and unified” article. The article pointed out: “In recent years, there are two major problems in drug batch management: 1. There is no uniform method for preparing batch numbers of pharmaceutical products. 2. Impressions of batches of enterprises are not standardized.” It is true that in the actual work, Quality management of the major projects, but I do not agree with the views described in this article. Discuss the issue of drug batch numbers, we must first clear the concept of “batch” of drugs. Article 69 of the “Good Manufacturing Practices for Pharmaceutical Production” (GMP) promulgated by the State Drug Administration in 1998 clearly stipulates that “batches” have the same character and quality within the prescribed limits and be distributed within the same production week