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《中华人民共和国药品管理法实施办法》第40条明确规定,购买药品必须验收生产批号等内容。实际工作中,药品生产批号已成为药品质量管理中的主要项目。 近年来药品生产批号的现状令人担扰,存在批号的编排、印注混乱等问题。主要是: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。卫生部规定的药品生产批号书写形式包括日号和分号。日号以6位数表示,前两位表示年,中间两位表示月,未尾两位表示日。分号前用短横线与日号相连表示批次,如
Article 40 of the Measures for the Implementation of the Drug Administration Law of the People’s Republic of China clearly stipulates that the purchase of medicines must be checked and approved for production batch numbers and other contents. In actual work, the lot number of drug production has become the major item in the quality control of medicines. In recent years, the status quo of drug production batch number is disturbing, there are batch number arrangement, printed note confusion and other issues. Mainly: ① drug production batch number preparation method is not uniform; ② business printing of non-standard batch number. The drug production batch number written by the Ministry of Health includes the day number and the semicolon. Day number to 6 digits, the first two said the year, the middle two said the month, the last two said Japan. Use a dash before the semicolon to connect with the day number, such as