制剂生产规范化管理就是按照GMP管理方法,进行制剂生产实践,即在整个生产过程中,实行全部监控措施,用全面质量管理,保证制剂的安全性、有效性和稳定性。我们根据GMP这一制剂生产和质量管理指南,探索与试行了我院制剂生产全过程的规范化管理。 The standardized management of preparation production is to carry out the preparation production practice according to the GMP management method, that is, in the entire production process, all the monitoring measures are implemented and the total quality management is adopted to ensure the safety, effectiveness and stability of the preparation. We have explored and piloted the standardized management of the whole process of preparation in our hospital according to the GMP preparation and quality management guidelines.