ISPE 第三卷：无菌产品生产设施（第三版）2018年 Baseline Guide Vol 3 Sterile Produ.pdfVIP

VOLUME3

SterileProduct

ManufacturingFacilities

ThirdEdition

Disclaimer:

ThisBaseline®Guidefocusesonengineeringaspectsofdesigningfacilitiesforthemanufactureofsterileproducts.

Itisintendedtoofferbestpracticesinthedesignofaneworrenovatedfacility,byprovidinganapproachthatis

effective,cost-efficient,andincompliancewithexistingregulationsandrelatedguidance.ThisGuideissolelycreated

andownedbyISPE.Itisnotaregulation,standardorregulatoryguidelinedocument.ISPEcannotensureanddoes

notwarrantthatasystemmanagedinaccordancewiththisGuidewillbeacceptabletoregulatoryauthorities.Further,

thisGuidedoesnotreplacetheneedforhiringprofessionalengineersortechnicians.

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©CopyrightISPE2018.Allrightsreserved.

Allrightsreserved.Nopartofthisdocumentmaybereproducedorcopiedinanyformorbyanymeans–graphic,

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ISBN978-1-946964-06-9

Forindividualuseonly.©CopyrightISPE2018.Allrightsreserved.

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