Tablets & Capsules

TC1020

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20 October 2020 Tablets & Capsules That's why a good SGS engages the RS team from the start, putting them in the foxhole alongside R&D so they can proactively translate scientific data into real-time, evidence-based documentation at each stage gate. By the time a product reaches a late stage, such as the bio-batch manufacturing that immediately precedes the final docu- mentation step, the RS team is already well on their way to completing their full FDA submission. Not only that, they've likely accrued more science-based evidence than the regulations require, giving the FDA a meticulous and comprehensive argument in favor of swift approval and preventing or reducing further delays caused by post- approval changes. You'll eliminate costly knowledge gaps between teams. Risk thrives in the gaps between fragmented teams. If your R&D and RS teams aren't integrated, you risk lost time while they manually exchange, translate, and update information, and quality may backslide as data is pushed and pulled from one team to the other. Your SGS will introduce a leaner, more streamlined process that integrates disparate roles and responsibili- ties, eliminating these knowledge gaps and protecting the integrity of source data. This harmonized approach isn't limited to the R&D and RS teams; in a facility governed by a well-executed SGS, cross-training and knowledge sharing happens continuously, between all teams and at every stage in the development process. By the time a product is ready for commercial manufacturing, tech- nology transfer is well underway, with information and insight flowing smoothly from one end of the product's lifecycle to the other. You'll have improved cost control and minimal down- time. Historic approaches to drug product approval hinged on the product's final release. How the product got there was more or less extraneous to the regulatory outcome. QbD works differently. It seeks to examine your drug production process down to its elemental parts, so that every variable that could potentially impact your prod- uct's quality in its journey to final release is uncovered, understood, and optimized. This matters to regulators with a QbD agenda, and it should matter to manufactur- ers who want to control their bottom lines while main- taining the trust and loyalty of their end consumers. R&D and regulatory sciences and submissions (RS) teams work, primarily by ensuring that they work together. It updates more traditional relay-based workflows, in which an R&D team might "hand off" information like a baton to the RS team. Instead, a workflow driven by SGS and based on QbD principles sees both teams working closely together from the start, with knowl- edge transfer included as a natural feature of the product development lifecycle. How a stage gate system can improve your regulatory and commercial success An SGS prioritizes everything that matters to a gener- ics OSD manufacturer—cost savings, speed, flexibil- ity, and quality—and eliminates or minimizes all of the redundancies and vulnerabilities that get in the way of those objectives. The result isn't just about bringing a product to market, it's about developing a holistic and harmonized drug development and regulatory submis- sions program that will pay dividends on every new investigational project. This is what you can expect: Your ROI will be higher, and you'll get to it sooner. For drug product manufacturers, ROI is a question of speed. The faster and less onerous the regulatory approval process, the sooner a drug product graduates from the costly development pipeline into the commer- cial marketplace, flipping a project from red to black. Your SGS will introduce a leaner, more streamlined process that integrates disparate roles and responsibilities, eliminating these knowledge gaps and protecting the integrity of source data. Sign up now by emailing kmyers@cscpub.com your name, company, and email address. To see a sample, please visit our website.

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