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.
Top Sellers:
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ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI) from Concept to Continual Improvement Part 3 – Change Management System as a Key Element of a Pharmaceutical Quality System
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ISPE Baseline Guide: Volume 2 – Oral Solid Dosage Forms
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ISPE Baseline Guide: Volume 6 – Biopharmaceutical Manufacturing Facilities
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ISPE Good Practice Guide: Development of Investigational Therapeutic Biological Products
New Revisions:
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ISPE Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms
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ISPE Good Practice Guide: HVAC and Process Equipment Air Filters
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ISPE GAMP Good Practice Guide: Computerized GCP Systems & Data
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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
Explore More in ISPE
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GAMP Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures
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ISPE Good Practice Guide: Equipment Reliability
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GAMP Good Practice Guide: Enabling Innovation
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ISPE Good Practice Guide: Heating, Ventilation, and Air Conditioning (HVAC)
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ISPE Good Practice Guide: Single-Use Technology
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ISPE Good Practice Guide: Packaging, Labeling, and Warehousing Facilities
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GAMP Good Practice Guide: A Risk-Based Approach to Calibration Management, Second Edition
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ISPE Guide: Biopharmaceutical Process Development and Manufacturing
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ISPE Good Practice Guide: Clinical Supply Systems
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ISPE Good Practice Guide: Controlled Temperature Chambers Commissioning and Qualification Mapping and Monitoring
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GAMP Good Practice Guide: Data Integrity – Manufacturing Records
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GAMP Good Practice Guide: A Risk-Based Approach to Testing of GxP Systems (Second Edition)
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GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems (German Version)
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ISPE Baseline Guide: Volume 4 – Water and Steam Systems, Third Edition
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ISPE Good Practice Guide: Membrane-Based Water Injection Systems
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ISPE Good Practice Guide: Critical Utilities GMP Compliance