ISPE
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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 PDF
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ISPE Baseline Guide: Volume 4 – Water and Steam Systems, Third Edition PDF
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ISPE Guide: ATMPs – Autologous Cell Therapy PDF
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ISPE Good Practice Guide: Decommissioning of Pharmaceutical Equipment and Facilities PDF
New Revisions:
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ISPE Guide: Cleaning Validation Lifecycle – Applications, Methods, & Controls PDF
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GAMP Good Practice Guide: Manufacturing Execution Systems – A Strategic and Program Management Approach PDF
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ISPE Good Practice Guide: Clinical Supply Systems PDF
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GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems (German Version) PDF
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ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI) from Concept to Continual Improvement Part 4 – Process Performance and Product Quality Monitoring System PDF
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ISPE Guide: ATMPs – Autologous Cell Therapy PDF
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ISPE Guide: Biopharmaceutical Process Development and Manufacturing PDF
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ISPE Guide: Cleaning Validation Lifecycle – Applications, Methods, & Controls PDF
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ISPE Sustainability Handbook PDF