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《中华人民共和国药品管理法》对药品包装管理有明确规范,直接接触药品的包装材料和容器,必须符合药用要求,符合保障人体健康安全的标准,并由药品监督管理部门在审批药品时一并审批。药品生产企业不得使用未经批准的直接接触药品的包装材料和容器。《药品生产质量管理规范》中对药品包装材料也提出了明确的要求,因此医药企业在实施GMP的同时,不能忽视对药品包装材料的管理。首先在包装材料采购上要把好关,其次认真做好检验、入库、发货等具体工具。总之,包装材料的管理是药品GMP的一个重要组成部分,只有切实做好每一步细致工作,才能把好包装材料的质量关,才能有力地保证GMP顺利实施。
Drug Administration Law of the People’s Republic of China specifies the packaging management of pharmaceutical products. The packaging materials and containers that directly contact with pharmaceuticals must comply with the medicinal requirements and meet the standards for ensuring human health and safety. Drug regulatory authorities And approval. Pharmaceutical manufacturers may not use unapproved packaging materials and containers that come into direct contact with medicines. Pharmaceutical manufacturing quality management norms on pharmaceutical packaging materials also made a clear request, pharmaceutical companies in the implementation of GMP at the same time, can not ignore the management of pharmaceutical packaging materials. First in the procurement of packaging materials should be good off, followed by careful inspection, storage, delivery and other specific tools. In short, the management of packaging materials is an important part of pharmaceutical GMP, and only properly do every step of the meticulous work in order to ensure the quality of packaging materials in order to effectively ensure the smooth implementation of GMP.