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1、NCPCHebeiHuaminPharmaceuticalCo.,LTD華北制藥河北華民藥業(yè)有限責(zé)任公司Doc.No.文件編號NewCephalosporinsFactory新頭孢工廠Page頁碼35of45CefuroximeAxetilUsingEquipmentCleaningValidationProtocol頭孢呋辛酯使用設(shè)備清洗驗證方案CefuroximeAxetilUsingEquipmentCleaningValidationProtocol頭孢呋辛酯使用設(shè)備清洗驗證方案ProtocolApproval方案批準(zhǔn)Company/Title公司/職務(wù)Name姓名Signat
2、ure簽名Date日期Writtenby起草Austar/ValidationEngineer奧星/驗證工程師張映雪Reviewedby審核NCPC/NCProcessEngineer華藥華民/非無菌原料工藝工程師周平凡NCPC/NCEquipmentEngineer華藥華民/非無菌原料設(shè)備工程師楊志云NCPC/QAValidationEngineer華藥華民/QA驗證工程師王柳NCPC/QCQCManager華藥華民/QC負(fù)責(zé)人王冕NCPC/QAManager華藥華民/QA負(fù)責(zé)人沈梅Approvedby批準(zhǔn)NCPC/NCManager華藥華民/非無菌原料負(fù)責(zé)人劉東NCPC/Quali
3、tyManager華藥華民/質(zhì)量負(fù)責(zé)人劉樹林RESIVION版本ISSUEDDATE頒布日期REASONFORNEWISSUE頒布原因REV.00INITIALISSUE首次頒布NCPCHebeiHuaminPharmaceuticalCo.,LTD華北制藥河北華民藥業(yè)有限責(zé)任公司Doc.No.文件編號NewCephalosporinsFactory新頭孢工廠Page頁碼35of45CefuroximeAxetilUsingEquipmentCleaningValidationProtocol頭孢呋辛酯使用設(shè)備清洗驗證方案Index目錄1.PURPOSE目的42.SCOPE范圍43.R
4、ESPONSIBILITY職責(zé)54.REGULATIONANDGUIDANCE法規(guī)和指南65.ABBREVIATIONS縮略語76.CEFUROXIMEAXETILPROCESSFLOW頭孢呋辛酯工藝流程圖87.GOODDOCUMENTATIONPRACTICE文件管理規(guī)范98.SAMPLINGPROCEDURES取樣程序118.1Activepharmaceuticalingredientresiduessamplingprocedures活性成分殘留取樣程序118.1.1Swabsample棉簽法取樣118.2pH,conductivitysamplingprocedures酸堿度
5、、電導(dǎo)率取樣程序118.2.1Rinsesample沖淋法取樣118.3Samplecodingprinciple樣品編號原則128.4Samplingprinciples取樣原則129.EQUIPMENTDESCRIPTION設(shè)備描述139.1Listofequipmentareasindirectcontactwiththeactiveingredients與活性成分直接接觸設(shè)備面積清單139.2Positionsofequipmentsamplingpoints設(shè)備取樣點位置1410.ACCEPTANCECRITERIA可接受標(biāo)準(zhǔn)1710.1Visualchecks目視檢查171
6、0.2Activepharmaceuticalingredientresidues活性成分殘留1710.2.1Principles原理1710.2.2TargetProductSelection目標(biāo)產(chǎn)品選擇1710.2.3Minimumdailytherapeuticdosagecriteria最低日治療劑量標(biāo)準(zhǔn)1710.2.410ppmcriteria10ppm標(biāo)準(zhǔn)1810.2.5Comparisonofcalculationresults計算結(jié)果對比1910.2.6Thecalculationoftheactiveingredientresidueperunitarea單位面積活性
7、成分NCPCHebeiHuaminPharmaceuticalCo.,LTD華北制藥河北華民藥業(yè)有限責(zé)任公司Doc.No.文件編號NewCephalosporinsFactory新頭孢工廠Page頁碼35of45CefuroximeAxetilUsingEquipmentCleaningValidationProtocol頭孢呋辛酯使用設(shè)備清洗驗證方案殘留的計算1910.2.7Others其它1911.VALIDATIONDESCRIPTION
