Remove topic process-analytical-technology-pat-articles
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Regulators and Industry Discuss Digital Transformation and Pharma 4.0™

ISPE

™ Thomas ZIMMER, PhD 26 June 2023 The upcoming challenges and opportunities of digital transformation were the topic of a panel discussion held on 9 May 2023 at the 2023 ISPE Europe Annual Conference in Amsterdam, The Netherlands. The Process Analytical Technology (PAT) concept can thus be fully realized.

FDA 97
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Digital Transformation at the 2023 Annual Meeting & Expo

ISPE

Digital Transformation is the possibility that digital technologies can facilitate efficiency gains and increased customer satisfaction, but many assume just applying the technology automatically results in those improvements. The Pharma 4.0™ Core to Pharma 4.0™

FDA 96
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ICH Q13 and What Is Next for Continuous Manufacturing

ISPE

[link] ICH Q13 defines CM as follows: “CM involves the continuous feeding of input materials into, the transformation of in-process materials within, and the concomitant removal of output materials from a manufacturing process.”

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Considerations for a Decentralized Manufacturing Paradigm

ISPE

There are regulatory strategies and technologies emerging to address these challenges, but further progress must be made to fully harness the advantages of advanced and decentralized manufacturing techniques. ™ technologies. ™ technologies.

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Environmental Sustainability in Biopharmaceutical Facility Design

ISPE

Whitford Emily Heffernan, PE Aoife Kelly 1 March 2023 Many emerging tools and technologies support the environmental sustainability of the pharmaceutical industry. In facility design, solutions are derived through science-based analyses of environmental impacts from the materials, processes, services, and architecture.