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Pharmaceutical Technology QUALITY AND REGULATORY SOURCEBOOK EBOOK MARCH 2022 23 manufacturing process, improve yield, and guar- antee product consistency and quality. Opening the door to new innovations and efficiencies The ability to apply AI governance to other algo- rithms in highly regulated drug and medical de- vice manufacturing environments opens the door for all sorts of innovation. Companies will be able to take advantage of AI/ML to find new ways to scale operations and production while ensuring the quality of delivered therapeutic and medical device products and services. This ability will re- sult in an economy of scale that leads to safer, more efficient, and effective patient outcomes; make us more resilient in the face of future health threats; and open the door to finally realizing the promise of a fully digitalized Pharma 4.0. References 1. EDQM, EurPh, General Text 5.21 (EDQM, Strasbourg, France, 2017) 2. FDA, Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan (January 2021). 3. FDA, Guidance for Industry, Process Validation: General Principles and Practices (Rockville, MD, January 2011). 4. T. Manzano et al., J. Pharm. Sci. Tech. online DOI:10.5731/pda- jpst.2019.011338 (August 2020). 5. FDA, Proposed Regulatory Framework for Modifications to Arti- ficial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD): Discussion Paper and Request for Feed- back (April 2019). 6. EMA, HMA-EMA Joint Big Data Taskforce Phase II report: Evolv- ing Data-Driven Regulation (March 2020). PT High performance Raman systems for a range of applications Raman spectroscopy produces chemical and structural images to help you understand more about the material being analyzed. Renishaw has decades of experience developing flexible Raman systems that give reliable results, for even the most challenging measurements. With Renishaw's suite of Raman systems, you can see the small things, the large things and things you didn't even know were there. usa@renishaw.com Renishaw, Inc. West Dundee, IL © 2021 Renishaw, Inc. All rights reserved. www.renishaw.com/raman Next generation Raman Imaging RamanNextGenSpectroscopy1_2022.indd 1 RamanNextGenSpectroscopy1_2022.indd 1 12/23/21 11:19 AM 12/23/21 11:19 AM Visit PharmTech.com to read the following articles on the use of artificial intelligence in pharma manufacturing: • Use of AI is Growing in Pharma www.PharmTech.com/view/use-ai-growing-pharma • Visual Inspection: Seeing Room for Improvement? www.PharmTech.com/view/visual-inspection-seeing- room-for-improvement • Automating Quality Checks www.PharmTech.com/view/automating-quality-checks More on Artificial Intelligence