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01 July, 2025|iSpeak BlogThe pharmaceutical industry is no stranger to innovation. From pioneering drug development to advanced manufacturing processes, it thrives on new ideas. But when it comes to
27 June, 2025|iSpeak BlogUsed correctly in the pharmaceutical industry, artificial intelligence (AI) has the possibility to help scientists, researchers, engineers, and manufacturers develop and
26 June, 2025|iSpeak BlogA Message from the President and CEO, ISPE A New Chapter for ISPE in China: Reflections from Shanghai As I approach the six-month mark in my role as President and CEO of ISPE - Calendar Of Events
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Guidance Documents
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Good Practice Guide: Validation 4.0
Good Practice Guide: Validation 4.0
Good Practice Guide: Validation 4.0
PublishedThe Validation 4.0 Guide provides a comprehensive approach to ensuring product quality and patient safety throughout a pharmaceutical product's lifecycle. A Holistic Control Strategy (HCS) in this context means moving beyond traditional, static, upfront and localized validation controls to a dynamic, data-driven, and continuous approach to managing risks and quality along the broader value chain. -
Good Practice Guide: Digital Validation
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Good Practice Guide: SMEPAC - Standardized Methodology for the Eval of Pharm Airborne Particle Emissions 3rd Edition
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Good Practice Guide: Ozone Sanitization of Pharm Water Storage & Distribution Systems 2nd Edition
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