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.
Showing 1–16 of 83 resultsSorted by popularity
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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
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ISPE Good Practice Guide: Booklet Labels
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ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI) from Concept to Continual Improvement Part 1 – Product Realization using QbD, Concepts and Principles
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ISPE Good Practice Guide: Packaging, Labeling, and Warehousing Facilities
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GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems (German Version)
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ISPE Good Practice Guide: Heating, Ventilation, and Air Conditioning (HVAC) Second Edition
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ISPE Guide: 503B Compounding
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ISPE Guide: ATMPs – Autologous Cell Therapy
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ISPE Good Practice Guide: Maintenance
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GAMP Good Practice Guide: Data Integrity by Design
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ISPE Baseline Guide: Volume 7 – Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP)
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ISPE Good Practice Guide: Development of Investigational Therapeutic Biological Products
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GAMP Good Practice Guide: Electronic Data Archiving
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GAMP Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures
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APQ Guide: Process Performance & Product Quality Monitoring System (PPPQMS)
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ISPE Baseline Guide: Volume 8: Pharma 4.0, 1st Edition