【正文】 風(fēng)險分析9. Sampling Plan 抽樣計劃10. Action taken when outoflimit result found對不符合接受限度的測試結(jié)果所采取的措施12. Revalidation 再驗證13. Cleaning Validation Executive Record清潔驗證過程記錄14. Conclusion結(jié)論Attachments附件 Written by: 制訂者：Date: 日期：Reviewed by: 復(fù)核者：Date: 日期：Approved by: 批準(zhǔn)者：Date: 日期：Approved by: 批準(zhǔn)者：Date: 日期：1. Responsibility 職責(zé)l QA is responsible for plan the cleaning validation. QA負(fù)責(zé)整個清潔驗證的安排l QC is responsible for sampling and analysis.QC 負(fù)責(zé)抽樣及測試 l Production Department is responsible for performing cleaning production equipment. 生產(chǎn)部負(fù)責(zé)設(shè)備的清潔.2. Purpose目的The purpose of this cleaning validation protocol is to demonstrate that the cleaning procedure used to clean JHZ250B high shear mixer / granulator, three－dimensional mixer，CTC2 Hot Air Circulating Drier， JZF400 granulators amp。 mill Korsch PH30036 Tablet Press，BGD150D highefficiency coating machine and DPP250B blister packaging machine can effectively remove residues of the products manufactured in ZS650 Vortex Oscillator/Compact Sieve，JHZ250B high shear mixer / granulator, three－dimensional mixer，CTC2 Hot Air Circulating Drier， JZF400 granulators amp。 3. Frequency周期The cleaning validation study is performed after three consecutive major cleanings of ZS650 Vortex Oscillator/Compact Sieve，JHZ250B high shear mixer / granulator, three－dimensional mixer，CTC2 Hot Air Circulating Drier， JZF400 granulators amp。4. Relevant SOP’s相關(guān)的 SOP’sSOPPD30400Cleaning procedure forHLSG300High Speed Mixer/GranulatorHLSG300型高效濕法混合制粒機清潔操作規(guī)程SOPPD30400Cleaning procedure forLF120EB airpillowdry GranulatorLF120EB型沸騰干燥制粒機清潔操作規(guī)程SOPPD31000Cleaning procedure for ZP43 High Speed rotary tablet press高效ZP43旋轉(zhuǎn)式壓片機清潔操作規(guī)程SOPPD30700Cleaning procedure for HLD1000B Hopper type of blenderHLD1000B型料斗式混合機清潔操作規(guī)程SOPPD30600Cleaning procedure for YK160 granulators YK160整粒機清潔操作規(guī)程SOPPD31100Cleaning procedure for BG300E highefficiency coating machineBG300E型高效包衣機清潔操作規(guī)程SOPPD31300Cleaning procedure forDPH1 DPP250B blister packaging machine DPH1DPP250型鋁塑袍罩包裝機清潔操作規(guī)程ESSVD007Validation guideline – cleaning驗證指南－清潔驗證ESSVD011Surface sampling for cleaning validation清洗驗證設(shè)備表面取樣ESSVD014Selection of the worst case in cleaning validation清潔驗證中最壞情況的選擇SOPQC1075檢驗操作規(guī)程ESSGM066Microbe Test 微生物限度檢測法5. Equipments設(shè)備No.序號Equipment No.設(shè)備編號Equipment Name設(shè)備名稱Product Contact Surface Area與產(chǎn)品接觸面積(m2)1HLSG300 high speed mixer / granulatorHLSG300高效濕法混合制粒機LF120EB airpillowdry GranulatorLF120EB沸騰干燥制粒機器3ZP43Tablet PressZP43旋轉(zhuǎn)式壓片機64METAL DETECTOR金屬探測儀5HLD1000BHLD1000B Hopper type of blenderHLD1000B型料斗式混合機6YK160granulators YK160型整粒機7DPH130\DPP250blister packaging machineDPH1DPP250型多功能自動鋁塑包裝機8BG300Ehighefficiency coating machineBG300E型高效包衣機Total Product Contact Surface Area (m2)與產(chǎn)品接觸面積總和(m2) List of Equipment設(shè)備清單The list of Equipment used in the manufacture of Lovastatin Tablets:有關(guān)鯊魚軟骨片生產(chǎn)線的所有機器列出如下：1．HLSG300 high speed mixer / granulator HLSG300高效濕法混合制粒機 2. LF120EB airpillowdry Granulator LF120EB沸騰干燥制粒機器 3. ZP43Tablet Press ZP43 Tablet Press ZP43旋轉(zhuǎn)式壓片機 4. METAL DETECTOR 金屬探測儀 5. HLD1000BHLD1000B Hopper type of blender HLD1000B 型料斗式混合機 6. YK160granulators YK160 型整粒機7. DPH130\DPP250blister packaging machine DPH1DPP250型多功能自動鋁塑包裝機8. BG300Ehighefficiency coating machine BG300E型高效包衣機Table 1表1: Validation Scope驗證范圍 l HLSG300 high shear mixer / granulator HLSG300高效濕法制粒機l LF120EB airpillowdry Granulator LF120EB沸騰干燥制粒機器l ZP43Tablet Press ZP43旋轉(zhuǎn)式壓片機l METAL DETECTOR 金屬探測儀l HLD1000B granule mixer HLD1000B型料斗式混合機l YK160 granulators YK160型整粒機l DPH1DPP250