浅谈医院制剂室持续性实施GPP的方法

目的:持续性实施《医疗机构制剂配制质量管理规范》(GPP),巩固GPP认证成果。方法:介绍我院制剂室GPP认证后加强生产和质量管理的具体做法。结果与结论:通过完善GPP文件系统和促进其实施的制度,健全了生产和质量管理体系,实现了人本管理向文本管理的转变;借助内部微机联网管理加强了生产在线监控和制剂质量管理;员工们对GPP认识的提高,使GPP的各项要求有效地贯彻到制剂生产、管理、保管、发放的全过程、全方面。由此,我院制剂室实现了有效、持续的GPP管理。

Application of Persistent Good Preparation Practice in Hospital Manufacturing Department

OBJECTIVE： To implement GPP persistently and consolidate the authentication result of GPP. METHODS： We introduced the specific ways for the strengthened management of production ＆ quality in manufacturing department of our hospital after the introduction of GPP authentication. RESULTS ＆ CONCLUSIONS： Due to the improvement and practice of GPP file system, the production ＆ quality management level was perfected and transition from human-oriented management to text management was achieved. On -llne monitoring of production and quality management of preparations were strengthened by means of internal microcomputer network. Staff＇s enhanced cognition level on GPP facilitated the effective and comprehensive implementation of GPP throughout production, management, storage and distribution of preparations. Hence, effective and persistent GPP management has been realized in manufacturing department of our hospital.