药品生产的风 险管理.pptVIP

* 实施风险评估就像。。。 最薄弱的环节不再是问题。。。 * 机遇和优势 鼓励透明决策 使决策更科学 帮助交流 多方面团队合作 赢得各方的信任 采用预防措施 主动控制风险 共享知识 行为改变 更好理解风险决策 接受风险 * 谢谢 电话邮箱：matewu@163.com Q Q :732050423 World Health Organization * * 1. Conduct a hazard analysis. 2. Determine the critical control points (CCPs). 3. Establish target levels and critical limit(s). 4. Establish a system to monitor the CCPs. 5. Establish the corrective action to be taken when monitoring indicates that a particular CCP is not under control. 6. Establish procedures to verify that the HACCP system is working effectively. 7. Establish documentation concerning all procedures and keep records appropriate to these principles and their application. Application The application of HACCP principles consists of the following 12 stages, as identified in the logic sequence for application of HACCP. 1. Assemble a HACCP team The pharmaceutical manufacturer should assure that product-specific knowledge and expertise are available for the development of an effective HACCP plan. This may be best accomplished by assembling a multidisciplinary team. Team members should therefore represent all the relevant disciplines, such as research and development, production, quality control, quality assurance, microbiology, engineering and distribution or others as applicable. Team members should have specific knowledge and expertise regarding the product and process. Where such expertise is not available on site, expert advice should be obtained from other sources. Team members should be able to: (a) conduct a hazard analysis; (b) identify potential hazards; (c) identify hazards which should be controlled; (d) recommend controls and critical limits; (e) devise procedures for monitoring and verification; (f ) recommend appropriate corrective action where deviations occur; (g) verify the HACCP plan. The scope of the HACCP plan should be defined. The scope should describe the segment of the process involved and the classes of hazards to be addressed should be