欧盟清洁验证方案带风险分析模板.docxVIP

欧盟清洁验证方案带风险分析 Subject/ 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 目录 1. Responsibility 职责 2. Purpose 目的 3. Frequency 周期 4. Relevant SOP s 相关的SOP s 5. Equipment 设备 6. Test Method 测试方法 7. Acceptance Criteria 接受限度 8. Risk Analysis 风险分析 9. Sampling Plan 抽样计划 10. Action taken when out-of-limit result found 对不符合接受限度的测试结果所采取的措施 12. Revalidation 再验证 13. Cleaning Validation Executive Record 清洁验证过程记录 14. Conclusion 结论 Attachments 附件 Written by: 制订者： Date: 日期： Reviewed by: 复核者： Date: 日期： Approved by: 批准者： Date: 日期： Approved by: 批准者： Date: 日期： Responsibility 职责 QA is responsible for plan the cleaning validation. QA负责整个清洁验证的安排 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明 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型多功能白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 Vortex Oscillator/Compact Sieve, JHZ-250B high shear mixer / granulator, three — dimensional mixer, CT-C-2 Hot Air C