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 Baseline Guide: Volume 5 – Commissioning and Qualification, 2nd Edition
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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: Manufacturing Execution Systems – A Strategic and Program Management Approach
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ISPE Baseline Guide: Volume 6 – Biopharmaceutical Manufacturing Facilities
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ISPE Good Practice Guide: Harmonizing the Definition and Use of Non-Investigational Medicinal Products (NIMPs)
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ISPE Baseline Guide: Volume 1 – Active Pharmaceutical Ingredients (Second Edition)
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ISPE Good Practice Guide: Process Validation
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ISPE GAMP Good Practice Guide: Computerized GCP Systems & Data
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ISPE Good Practice Guide: Process Gases
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ISPE Good Practice Guide: Maintenance
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ISPE Guide: Cleaning Validation Lifecycle – Applications, Methods, & Controls
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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: Good Engineering Practice, Second Edition
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ISPE Baseline Guide: Volume 7 – Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP)
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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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Good Practice Guide: Investigational Medicinal Product Reverse Logistics
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ISPE Good Practice Guide: Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems
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GAMP Good Practice Guide: A Risk-Based Approach to GxP Process Control
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ISPE Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms
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ISPE Good Practice Guide: Asset Management