欧盟清洁验证方案

精品文档---下载后可任意编辑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’s5. 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实行的措施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：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.2. 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-2Hot Air Circulating Drier， JZF-400 granulators & mill Korsch PH300-36 Tablet Press，BGD-150D high-efficiency coating machineand 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-2Hot Air Circulating Drier， JZF-400 granulators & mill Korsch PH300-36 Tablet Press，BGD-150D high-efficiency coating machineand 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...