药品生产质量管理规范在外用药制剂生产管理中的应用

Application of GMP in Preparation Process of External Drugs

目的探讨药品生产质量管理规范在外用药制剂生产管理中的应用。方法从药品生产企业的外用药制剂生产现状和实际情况出发,以外用药市场上最常见的乳膏制剂为例,在调研的基础上,总结外用药制剂生产的质量管理现状分析及存在问题。结果运用先进的产品质量管理模式,提升外用药产品的生产管理水平,可提高产品市场占有率,减少企业因质量造成的损失成本。结论完善药品生产质量管理体系,才能保证整个药品生产和使用过程安全有效。

Objective To investigate the application of GMP in the preparation process management of external drugs. Methods Started from production status and actual situation of pharmaceutical manufacturers for external drugs, the most common cream formulations of external drugs preparations were used as example, then analyzed the quality management status and problems on the basis of research. Results The application of advanced quality management model could enhance the production management level of external drugs, and improve market percentage of the product, and reduce the cost of losses caused due to quality. Conclusion Only improvement the quality management system can ensure the safety and efficiency in the drug production and application.