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我有几本ISPE的文献,但还缺一些,愿意和各位蒲友互通有无。以下是我有的文献目录:
ISPE Good Practice Guide Process Gases
ISPE Good Practice Guide Technology Transfer, 2nd(2014)
ISPE GPG Project Management for the Pharmaceutical Industry
ISPE Guide:PEST CTRLDL-虫害防治
ISPE Proposals for FDA Quality Metrics Program - Whitepaper
ISPE-GPG-Tech Transfer
ISPE 白皮书Supply Chain Security
ISPE 白皮书Chamber Mapping_PKG
ISPE Good Practice Guide Cold Chain Management
ISPE Good Practice Guide Applied Risk Management for Commissioning and Qualification.pdf
ISPE Good Practice Guide Assessing the Particulate Containment Performance of Pharmaceutical Equipment
ISPE Good Practice Guide Maintenance
ISPE Good Practice Guide Packaging,Labeling and Warehousing Facilities
ISPE Good Practice Guide Project Management for the Pharmaceutical Industry
ISPE Good Practice Guide Quality Laboratory Facilities
ISPE Good Practice Guide Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment
ISPE PQLI*(全套共4本)
GAMP Good Practice Guide-A Risk-Based Approach to Compliant Electronic Records and Signatures
GAMP Good Practice Guide-A Risk-Electronic Data Archiving
GAMP? Good Practice Guide_Testing of GxP Systems
GAMP-Good Practice Guide -Validation of process control systems
ISPE GAMP Good Practice Guide-Validation of Laboratory Computerized Systems
补充内容 (2016-7-19 18:33):
需要A Risk-Based Approach to Compliant Electronic Records and Signatures正式版(非扫描件)
ISPE Good Practice Guide Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equ...
补充内容 (2016-7-19 18:33):
ISPE Good Practice Guide Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment正式版(非扫描件)
A Risk-Based Approach to GxP Compliant Laboratory Computerized Sy...
补充内容 (2016-7-19 19:36):
不好意思,搞错了ISPE PQLI(Part 1)
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