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1、NCPCHebeiHuaminPharmaceuticalCo.,LTD華北制藥河北華民藥業(yè)有限責任公司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Compa
2、ny/Title公司/職務(wù)Name姓名Signature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負責人王冕NCPC/QAManager華藥華民/QA負責人沈梅A
3、pprovedby批準NCPC/NCManager華藥華民/非無菌原料負責人劉東NCPC/QualityManager華藥華民/質(zhì)量負責人劉樹林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)有限責任公司Doc.No.文件編號NewCephalosporinsFactory新頭孢工廠Page頁碼35of45CefuroximeAxetilUsingEquipme
4、ntCleaningValidationProtocol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.RESPONSIBILITY職責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118.1Activepharmaceuticalingredien
5、tresiduessamplingprocedures活性成分殘留取樣程序118.1.1Swabsample棉簽法取樣118.2pH,conductivitysamplingprocedures酸堿度、電導率取樣程序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139.1Listofequipmentareasindirectcontactwiththeactive
6、ingredients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可接受標準1710.1Visualchecks目視檢查1710.2Activepharmaceuticalingredientresidues活性成分殘留1710.2.1Principles原理1710.2.2TargetProductSelection目標產(chǎn)品選擇1710.2.3Minimumdailytherapeuticdosagecriter
7、ia最低日治療劑量標準1710.2.410ppmcriteria10ppm標準1810.2.5Comparisonofcalculationresults計算結(jié)果對比1910.2.6Thecalculationoftheactiveingredientresidueperunitarea單位面積活性成分NCPCHebeiHuaminPharmaceuticalCo.,LTD華北制藥河北華民藥業(yè)有限責任公司Doc.No.文件編號NewCephalosporinsFactory新頭孢工廠Page頁碼35of45CefuroximeAxeti
8、lUsingEquipmentCleaningValidationProtocol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
