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Tablets & Capsules October 2020 21 A big impact on quality and the bottom line As the principles of QbD increasingly permeate the pharmaceutical industry, manufacturers are well advised to embrace an SGS. Not only does a well- executed SGS position a drug developer for smoother, faster regulatory approval, it also creates opportunities for improved financial outcomes overall, driven by the principles of evidence-based process control and end- to-end team integration. Whether you develop your own SGS or find an expe- rienced partner to design and operationalize one to suit your needs, this could be the most impactful and profit- able adaptation you make for years to come. T&C Deepak Thassu (719 226 5440, deepakthassu@nexgen pharma.com) is the vice president of R&D and Regulatory Sciences and Submissions at LGM Pharma (561 981 9994, www.lgmpharma.com), which partners with pharmaceutical companies to accelerate therapeutics from concept to commer- cialization. Thassu has twenty years of experience in the pharmaceutical industry and specializes in helping clients design and implement proprietary drug-delivery processes that set the stage for successful regulatory outcomes and resilient business growth. An SGS is an invaluable tool in this pursuit. It provides a framework for multivariate experimentation, which gives manufacturers real-time feedback on their batch-to-batch quality and consistency. This opens a vital window of opportunity for correcting deviations before it's too late, which dramatically reduces the risk of manufacturing downtime. The result is a healthier balance sheet and a better product. When challenges arise, you'll adapt quickly and cost-effectively. Even with the most robust SGS at your service, challenges happen. Safety signals precipitate pro- tocol amendments, turbulence in the API marketplace means switching to a new supplier, emerging technology offers you a new opportunity to stay competitive—any- thing is possible, and every drug development and regula- tory submissions process will need to navigate unforeseen change to some degree. Your SGS is designed for these moments. It provides the framework for developing very well-understood and metic- ulously documented processes, which comes with a big benefit: when you understand your process inside and out, you kn ow how to modify it without impacting your final product's quality. There are no mysteries or unexplored variables to throw production off track. And because you have the same integrated team working together on both your product-development activities and your submission paperwork, you can accommodate change with only minor updates to your required regulatory documentation. DUST DOESN'T HAVE TO BE A FOUR-LETTER WORD. © 2020 Donaldson Company, Inc. Donaldson.com 800.365.1331 DUST CONTROL DONE RIGHT. Pardon our language. When it comes to combustible dust, come to Donaldson. We're here to help you develop a risk-mitigation solution that meets your unique needs. From the initial site visit and process audit to installation and compliance support, Donaldson can help ensure you have the right solution in place. So keep it clean out there – put our world-class products and application expertise to work for you. Contact your local Donaldson representative for more information or to schedule a visit.