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¡¤Goodmanufacturingpracticesforpharmaceuticalproducts:mainprinciples,WHO,2014(WHO
TechnicalReportSeries986)
¡¤Good manufacturing practices: guidelines on validation, WHO, 2021. (WHO Technical Report
Series1019)
¡¤Draft working document for comments: Points to consider when including HBELs in cleaning
validation,WHO,WorkingdocumentQAS/20.849/Rev.1,August2020
¡¤GuidetoGoodManufacturingPracticeforMedicinalProductsPart1,PIC/S,2021
¡¤Cross-ContaminationinSharedFacilities,PIC/S,2018
¡¤ValidationofCleaningProcesses(7/93),USFDA
¡¤Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, Guide for
Industry,USFDA,2016
¡¤EU Guidelines for Good Manufacturing Practice for medicinal Products for Human and
VeterinaryUSE.Part1,Chapter5:Production,EuropeanCommision,August,2014
¡¤EU Guidelines for Good Manufacturing Practice for medicinal Products for Human and
VeterinaryUSE.Annex15:QualificationandValidation,EuropeanCommision,March,2015
¡¤Cleaningvalidationguide(GUI-0028),Canada,June2021
¡¤Guidance on Aspects of Cleaning Validation in Active Pharmaceutical Ingredient Plants, APIC,
September201
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¡¤¼¼Ã´¹ë¸®µ¥À̼ÇÇÁ·ÎÅäÄÝ(¹Î¿øÀξȳ»¼),½ÄÇ°ÀǾàÇ°¾ÈÀüó(2009)
¡¤Goodmanufacturingpracticesforpharmaceuticalproducts:mainprinciples,WHO,2014(WHO
TechnicalReportSeries986)
¡¤Good manufacturing practices: guidelines on validation, WHO, 2021. (WHO Technical Report
Series1019)
¡¤Draft working document for comments: Points to consider when including HBELs in cleaning
validation,WHO,WorkingdocumentQAS/20.849/Rev.1,August2020
¡¤GuidetoGoodManufacturingPracticeforMedicinalProductsPart1,PIC/S,2021
¡¤Cross-ContaminationinSharedFacilities,PIC/S,2018
¡¤ValidationofCleaningProcesses(7/93),USFDA
¡¤Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, Guide for
Industry,USFDA,2016
¡¤EU Guidelines for Good Manufacturing Practice for medicinal Products for Human and
VeterinaryUSE.Part1,Chapter5:Production,EuropeanCommision,August,2014
¡¤EU Guidelines for Good Manufacturing Practice for medicinal Products for Human and
VeterinaryUSE.Annex15:QualificationandValidation,EuropeanCommision,March,2015
¡¤Cleaningvalidationguide(GUI-0028),Canada,June2021
¡¤Guidance on Aspects of Cleaning Validation in Active Pharmaceutical Ingredient Plants, APIC,
September201
73
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