6、ISPE基准指南第6卷： 生物制药生产设施（第2版）-英-2013.pdf

Business

Integrity



Design

Innova�on



Process

Knowledge

Flexible

Facility

Design

Cleanrooms,

HVAC,

U�li�es

GMP

Bioprocess

Engineering

CIP/SIP/Single

Use

Technologies

Biopharm

Manufacturing

Exper�se

www.DME

Volume6

Biopharmaceutical

Manufacturing

Facilities

SecondEdition/November2013

Disclaimer:

ThisGuideemphasizestheuseofclosedsystemsasanapproachtomitigatingrisksassociatedwiththeproduction

ofbiopharmaceuticals.Itismeanttoassistpharmaceuticalmanufacturersinthedesignandconstructionofnewand

renovatedfacilitiesthatarerequiredtocomplywiththerequirementsoftheUSFoodandDrugAdministration(FDA).

TheInternationalSocietyforPharmaceuticalEngineering(ISPE)cannotensureanddoesnotwarrantthatasystem

managedinaccordancewiththisGuidewillbeacceptabletotheFDAorotherregulatoryauthorities.Further,this

Guidedoesnotreplacetheneedforhiringprofessionalengineersortechnicians.

LimitationofLiability

In no event shall ISPE or any of its affiliates, or the officers, directors, employees, members, or agents of each

of them, be liable for any damages of any kind, including without limitation any special, incidental, indirect, or

consequential damages, whether or not advised of the possibility of such damages, and on any theory of liability

whatsoever, arising out of or in connection with the use of thi