usp37-1111非无菌药品微生物检查：药用制剂和药用物质可接受标准(中英文)

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1、USP37<1111>非无菌药品微生物检查:药用制剂和药用物质可接受标准(中英文)(2014-06-0614:19:33)转载▼分类：食品药品＜1111＞MICROBIOLOGICALEXAMINATIONOFNONSTERILEPRODUCTS:ACCEPTANCECRITERIAFORPHARMACEUTICALPREPARATIONSANDSUBSTANCESFORPHARMACEUTICALUSE非无菌药品微生物检查：药用制剂和药用物质可接受标准Thepresenceofcertainmicroorganis

2、msinnonsterilepreparationsmayhavethepotentialtoreduceoreveninactivatethetherapeuticactivityoftheproductandhasapotentialtoadverselyaffectthehealthofthepatient.ManufacturershavethereforetoensurealowbioburdenoffinisheddosageformsbyimplementingcurrentguidelinesonGo

3、odManufacturingPracticeduringthemanufacture,storage,anddistributionofpharmaceuticalpreparations.在非无蘭制剂屮如果出现特定的微生物，可能会降低其至失去治疗活性，对患者健康产生潜在负面影响。因此，生产商需要通过在生产、存贮制剂的过程屮实施GMP现行指南，保证制剂的生物负载在一个较低的水平。Microbialexaminationofnonsterileproductsisperformedaccordingtothemeth

4、odsgiveninthetextsonMicrobialEnumerationTestsandTestsforSpecifiedMicroorganisms62.Acceptancecriteriafornonsterilepharmaceuticalproductsbaseduponthetotalaerobicmicrobialcount(TAMC)andthetotalcombinedyeastsandmoldscount(TYMC)aregiveninTables1and2.Acceptancecriter

5、iaarebasedonindividualresultsorontheaverageofreplicatecountswhenreplicatecountsareperformed(e.g.,directplatingmethods).非无蘭药品的微屯物检齊应根据＜61微生物限度检齊＞和＜62控制阐测试＞进行。非无尚药品的可接受标准根据表1和表2屮给定的“总有氧菌计数TAMC”和“总酵母阐和霉蘭计数TYMC”进行判定。是否符合可接受标准砬蕋于单个结果或S于重复计数(例如，平皿法)的平均结果来进行判定。Whenana

6、cceptancecriterionformicrobiologicalqualityisprescribed,itisinterpretedasfollows:如果指明了微生物质景的可接受标准，则含义如下—10icfu:maximumacceptablecount=20;—101cfu：最大可接受计数=20—102cfu:maximumacceptablecount=200;—102cfu:最大可接受计数=200—103cfu:maximumacceptablecount=2000;andsoforth.表1非无菌

7、制剂微生物质量可接受标准—103cfu：最大可接受计数=2000Table1.AcceptanceCriteriaforMicrobiologicalQualityofNonsterileDosageFormsRouteofAdministration摄入途径TotalAerobicMicrobialCount总有氧菌计数(cfu/gorcfu/mL)TotalCombinedYeasts/MoldsCount总酵母菌和霉菌计数(cfu/gorcfu/mL)SpecifiedMicroorganism(s)控制菌No

8、naquesouspreparationsfororaluse103103AbsenceofEscherichiacoli(1gor1mL)口服非水性制剂103103大肠杆蘭不得检出（1g或1ml）Aqueouspreparationsfororaluse102101AbsenceofEscherichiacoli(1gor1mL)口服水性制剂