ISPE
International Society for Pharmaceutical Engineering
ISPE provides education, training, forums, and technical documents for professionals in pharmaceutical manufacturing. The Society publishes best-practice guides on a wide array of topics, including bulk pharmaceutical chemicals, sterile manufacturing facilities, commissioning and qualification, biopharmaceutical manufacturing facilities, and technology transfer.
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ISPE GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems Digital PDF
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ISPE GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems, Second Edition Digital PDF
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ISPE GAMP Good Practice Guide: A Risk-Based Approach to Operation of GxP Computerized Systems – A Companion Volume to GAMP 5 Digital PDF
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ISPE GAMP Good Practice Guide: A Risk-Based Approach to Regulated Mobile Applications Digital PDF
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ISPE GAMP Good Practice Guide: Computerized GCP Systems & Data Digital PDF
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ISPE GAMP Good Practice Guide: Global Information Systems Control and Compliance (Second Edition) Digital PDF
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ISPE GAMP Good Practice Guide: IT Infrastructure Control and Compliance Digital PDF
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ISPE GAMP Guide: Records and Data Integrity Digital PDF
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ISPE GAMP RDI Good Practice Guide: Data Integrity – Key Concepts Digital PDF
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ISPE Good Practice Guide: Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems Digital PDF
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ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment Digital PDF
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ISPE Good Practice Guide: Asset Management Digital PDF
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