欧盟清洁验证方案带风险分析.docxVIP

S u b j e c t / 主 题 Lovastatin Tablets 20mg Cleaning Validation Protocol 鲨鱼软骨片清洁验证方案文件编号： Table of contents 名目 Responsibility 职责 Purpose 目的 Frequency 周期 Relevant SOP’s 相关的 SOP’s Equipment 设备 Test Method 测试方式 Acceptance Criteria 接受限度 Risk Analysis 风险分析 Sampling Plan 抽样规划 Action taken when out-of-limit result found 对不符合接受限度的测试结果所实行的措施 Revalidation 再验证 Cleaning Validation Executive Record 清洁验证经过记录 Conclusion 结论 Attachments 附件 Written by: 者： 制订 Date: 日期： Reviewed by: 者： 复核 Date: 日期： Approved by: 者： 批准 Date: 日期： Approved by: 者： 批准 Date: 日期： Responsibility 职责 QA is responsible for plan the cleaning validation. QA 负责整个清洁验证的布置 QC is responsible for sampling and analysis. QC 负责抽样及测试 Production Department is responsible for performing cleaning production equipment. 生产部负责设备的清洁. Purpose 目的 The purpose of this cleaning validation protocol is to demonstrate that the cleaning procedure used to clean JHZ-250B high shear mixer / granulator, three －dimensional mixer，CT-C-2 Hot Air Circulating Drier， JZF-400 granulators mill Korsch PH300-36 Tablet Press，BGD-150D high-efficiency coating machine and DPP-250B blister packaging machine can effectively remove residues of the products manufactured in ZS-650 Vortex Oscillator/Compact Sieve，JHZ-250B high shear mixer / granulator, three－dimensional mixer，CT-C-2 Hot Air Circulating Drier， JZF-400 granulators mill Korsch PH300-36 Tablet Press，BGD-150D high-efficiency coating machine and DPP-250B blister packaging machine to a predetermined level that does not raise any safety concerns. 清洗验证方案的目的是证实 JHZ-250B 高效湿法制粒机、 HLD-1000B 型料斗式混合机清洁操作规程、CT-T-II 型热风循环烘箱、JZF-400 型整粒、粉碎机、Korsch PH-300-36 旋转式压片机、BGD-150D 型高效包衣机和 DPP-250B 型多功能自动铝塑包装所使用的清洗程序能够有效地除去产品残留，达到预先确定的限度，从而达到对下批产品无影响。 Frequency 周期 The cleaning validation study is performed after three consecutive major cleanings of ZS-650 VortexOscillator/Compact Sieve，JHZ-250B high shear mixer / granulator, three － dimensional mixer ， CT-C-2 Hot Air Circulating Drier ， JZF-400 granulators mill Korsc