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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APQ Guide: Change Management (CM) System Digital PDF
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APQ Guide: Corrective Action & Preventive Action (CAPA) System Digital PDF
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APQ Guide: Cultural Excellence Digital PDF
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APQ Guide: Management Responsibilities & Review (MRR) Digital PDF
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APQ Guide: Process Performance & Product Quality Monitoring System (PPPQMS) Digital PDF
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Cultural Excellence Report Digital PDF
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GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems (German Version) Digital PDF
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GAMP Good Practice Guide: A Risk-Based Approach to Calibration Management, Second Edition Digital PDF
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GAMP Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures Digital PDF
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GAMP Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems (Second Edition) Digital PDF
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GAMP Good Practice Guide: A Risk-Based Approach to Testing of GxP Systems (Second Edition) Digital PDF
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GAMP Good Practice Guide: Data Integrity – Manufacturing Records Digital PDF
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