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 Good Practice Guide: Global Information Systems Control and Compliance (Second Edition)
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ISPE Good Practice Guide: Membrane-Based Water Injection Systems
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ISPE Good Practice Guide: Management Engineering Standards
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ISPE Good Practice Guide: Sampling for Pharmaceutical Water, Steam, and Process Gases
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ISPE Baseline Guide: Volume 6 – Biopharmaceutical Manufacturing Facilities
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ISPE GAMP Guide: Records and Data Integrity
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ISPE Good Practice Guide: Quality Laboratory Facilities
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ISPE Good Practice Guide: Sampling for Pharmaceutical Water, Steam, and Process Gases
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GAMP Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems (Second Edition)
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GAMP Good Practice Guide: Manufacturing Execution Systems – A Strategic and Program Management Approach
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GAMP Good Practice Guide: Electronic Data Archiving
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Good Practice Guide: Knowledge Management in the Pharmaceutical Industry
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ISPE Good Practice Guide: Decommissioning of Pharmaceutical Equipment and Facilities
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ISPE Good Practice Guide: Technology Transfer
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ISPE GAMP Good Practice Guide: Global Information Systems Control and Compliance (Second Edition)
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ISPE Good Practice Guide: Cold Chain Management