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124 Pharmaceutical Technology BUYERS' GUIDE 2020 P h a r mTe c h . c o m INNOVATION OUTLOOK THOUGHT LEADER SLONME - STOCK.ADOBE.COM S P O N S O R E D C O N T E N T Bahirathan Mahesan, PhD Regulatory Affairs and Quality Manager CapsCanada WHY PHARMACEUTICAL COMPANIES SHOULD START SUPPLEMENTING CAPSULE SUPPLIERS NOW Given the circumstances of the COVID-19 pandemic, many US- based pharmaceutical manufacturers are suddenly realizing that their existing overseas gelatin capsule supplier may not be able to continue to produce and deliver to meet their production schedules. A potential solution is to supplement their supply of gelatin capsules, preferably from domestic sources. The addition of capsule suppliers, however, is a time-consuming process. Pharmaceutical companies are therefore advised to look for alternative capsule sources now—before supply chain disruptions result in medicine shortage. Why should pharmaceutical companies be concerned? There have always been inherent risks associated with reliance on an overseas capsule supplier. Now the COVID-19 pandemic has added additional risks. The global supply of gelatin capsules is tightening, and this alone gives pharmaceutical companies reason to be concerned. Even for a domestic capsule manufacturer, pharmaceutical manufacturers must look at where the supplier sources their raw materials, from the safety, quality and availability standpoints. Plus, they must also examine their supplier's production capability, logistics, customer communications, and ability to deliver product. What does the process of changing capsule suppliers entail? As a US-based drug product manufacturer, there are a number of steps you must address to change gelatin capsule suppliers. These include: • Complete the supplier qualification process. • Request and review safety and process capability documentation. • Perform manufacturing trials. • Test the drug products made with the new capsules. • Determine the type of regulatory submission required for the change in capsule supplier. The time to get this process started is now and not when you discover that the supply chain you thought was reliable is not. ABOUT BAHIRATHAN MAHESAN, PHD Bahirathan Mahesan, PhD, holds a Ph.D. degree in Epidemiology and Community Health, from Louisiana State University and is a Certified QA and Regulatory Affairs professional. A subject matter expert in active pharmaceutical ingredient (API), medicinal drugs, excipient and dietary supplements. ABOUT CAPSCANADA CapsCanada® is a leading supplier of two-piece empty gelatin and HPMC capsules. With a vertically integrated supply chain system and a certified quality control process for traceability, CapsCanada offers a variety of capsule types and sizes, flavors, finishes, printing options, and custom colors. CAPSCANADA Company Name : CapsCanada Phone : 1.866.788.2888 Email : connect@capscanada.com Website : www.capscanada.com