欧盟清洁验证方案
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
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
同意限度
8. Risk Analysis
风险分析
9. Sampling Plan
抽样打算
10. Action taken when out-of-limit result found
对不符合同意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：

1. 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.
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-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阻碍。                                                                   
3. 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 Circulating Drier， JZF-400 granulators & mill Korsch PH300-36 Tablet Press，BGD-150D high-efficiency coating machine and DPP-250B blister packaging machine after the manufacture of Lovastatin Tablets.
连续三批生产后，进行清洗验证研究。
4. Relevant SOP’s相关的 SOP’s
SOP-PD-304-00
Cleaning procedure forHLSG-300High Speed Mixer/Granulator
HLSG-300型高效湿法混合制粒机清洁操作规程
SOP-PD-304-00
swabbingCleaning procedure forLF120E-B airpillow-dry Granulator
LF120E-B型沸腾干燥制粒机清洁操作规程
SOP-PD-310-00
Cleaning procedure for ZP43 High Speed rotary tablet press
高效ZP43旋转式压片机清洁操作规程
SOP-PD-307-00
Cleaning procedure for HLD-1000B Hopper type of blender
HLD-1000B型料斗式混合机清洁操作规程
SOP-PD-306-00
Cleaning procedure for YK-160 granulators
YK-160整粒机清洁操作规程
SOP-PD-311-00
Cleaning procedure for BG-300E high-efficiency coating machine
BG-300E型高效包衣机清洁操作规程
SOP-PD-313-00
Cleaning procedure forDPH-130、 DPP-250B blister packaging machine
DPH-130、DPP-250型铝塑袍罩包装机清洁操作规程
ESS-VD007
Validation guideline – cleaning
验证指南－清洁验证
ESS-VD011
Surface sampling for cleaning validation
清洗验证设备表面取样
ESS-VD014
Selection of the worst case in cleaning validation
清洁验证中最坏情形的选择
SOP-QC-1075
检验操作规程
ESS-GM066
Microbe Test
微生物限度检测法
5.Equipments设备
No.
序号
Equipment No.
设备编号
Equipment Name
设备名称
Product Contact Surface Area
与产品接触面积(m2)
1
HLSG-300 high speed mixer / granulator
HLSG-300高效湿法混合制粒机
2.81
LF120E-B airpillow-dry Granulator
LF120E-B沸腾干燥制粒机器
5.90
3
ZP43Tablet Press
ZP43旋转式压片机
6
4
METAL DETECTOR
金属探测仪
0.3
5
HLD-1000BHLD-1000B Hopper type of blender
HLD-1000B型料斗式混合机
5.25
6
YK-160granulators
YK-160型整粒机
0.37
7
DPH-130\DPP-250blister packaging machine
DPH-130、DPP-250型多功能自动铝塑包装机
1.0
8
BG-300Ehigh-efficiency coating machine
BG-300E型高效包衣机
8.43
Total Product Contact Surface Area (m2)
与产品接触面积总和(m2)
99.62
5.1 List of Equipment设备清单
The list of Equipment used in the manufacture of Lovastatin Tablets:
有关鲨鱼软骨片生产线的所有机器列出如下：
1．HLSG-300 high speed mixer / granulator HLSG-300高效湿法混合制粒机
        2.  LF120E-B airpillow-dry Granulator LF120E-B沸腾干燥制粒机器
        3. ZP43Tablet Press ZP43 Tablet Press ZP43旋转式压片机

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