Category Archives: Uncategorized

Real-Time Release Testing for Dissolution Has Arrived

Lonna Gordon Senior Engineer IPS-Integrated Project Services, LLC In October of 2011 in a presentation on real-time release testing (RTRT)[1], the FDA gave an example of how a multivariate model could create a surrogate for dissolution testing of tablets.  This … Continue reading

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Pharma 4.0 – Part 2, the Double-Edged Data Sword

By:  John Niziolek Associate Director, CSV IPS-Integrated Project Services, LLC This post is the second of a three part series exploring Pharma 4.0, its beneficial impact to organizations, and the additional steps necessary to maintain compliance with the new technologies. … Continue reading

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Lab 4.0 for CROs – Operations and Supply Chain Management Perspective

By: Komal Hatti, NCARB, LEED AP SME R&D, Sr. Process Architect IPS-Integrated Project Services, LLC The advancements in data analytics and ever-increasing competitive forces are driving more laboratories than ever before to adopt lean and Industry 4.0 principles. Once considered … Continue reading

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“Top Ten” CGMP Compliance Implications for Cell Therapy / ATMPs

As new medicines and treatments continue to evolve, so do the challenges with their production. Cell therapy facilities present many unique challenges from the intricacies of patient-specific autologous therapies to numerous high-risk manual aseptic manipulations during the processing. The “Top … Continue reading

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Pharma 4.0 – Will you embrace it?

By:  John Lyons Senior Process Engineer IPS-Integrated Project Services, LLC I’ve been wondering what to think of Pharma 4.0. Is it a buzzword to help push new, but not much improved, equipment and systems into the industry? Or is it … Continue reading

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Pharma 4.0 – Welcome to a Smarter Way of Manufacturing

By:  John Niziolek Associate Director, CSV IPS-Integrated Project Services, LLC This post is the first of a three part series exploring Pharma 4.0, its beneficial impact to organizations and the additional steps necessary to maintain compliance with the new technologies. … Continue reading

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Setting a Standard

By: Nikki Withers In contrast to food and beverage packaging, pharmaceutical packaging must, in many cases, be child resistant yet present no difficulty for its intended users – often elderly adults – to open and use properly. In the European … Continue reading

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