Pharmaceutical Technology - March 2022

Pharmaceutical Technology March 2022

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Pharmaceutical Technology QUALITY AND REGULATORY SOURCEBOOK EBOOK MARCH 2022 51 management systems, commitment to transpar- ency and strong communication, and capacity to support your current and future needs; all are criti- cal to ensure you've selected the right high-quality manufacturing partner. Regulatory considerations PharmTech: What particular regulatory requirements should companies be aware of when ensuring their products are secure within the supply chain? Lenox (LGM): The Drug Supply Chain Security Act was enacted in 2013 to further secure the drug sup- ply. It creates a tighter, closed prescription drug dis- tribution system to prevent harmful drugs from en- tering the supply chain, detect harmful drugs if they do enter the supply chain, and enable rapid response when such drugs are found. The law requires drugs to be traced as they move through the supply chain, and companies should only conduct business with licensed or registered trading partners. Kirk (Catalent): Over the past two years or so, supply chain challenges caused by the pandemic have led to many companies looking to consider alternative suppliers, products, and geographical solutions to avoid disruption. However, it is im- portant that these options never come with the risk of lower quality. It is always paramount to ensure that supplier compliance and integrity is assessed to relevant standards. Catalent uses several sup- plier monitoring tools, which range from supplier performance management, third-party risk moni- toring, supplier audits and, finally, critical material risk assessments and tracking. Together, these cre- ate a multi-layered approach so that macro- and micro-level risks to supply can be identified and prevented or rectified. PT • Webcasts • Digital Editions • Whitepapers • Videos • News updates • And more! ONLINE LEARNING Visit our website for the latest e-learning tools in the bio/ pharmaceutical industry. Visit us at pharmtech.com Adare Pharmaceuticals ............................................................................. 2 Aizon .......................................................................................................... 37 Alfa Laval, Inc ............................................................................................ 41 August Bioservices .................................................................................. 49 BASF Corporation .................................................................................... 45 Baxter Healthcare Corporation .............................................................. 55 Colbert Packaging .................................................................................... 53 Dot Compliance ........................................................................................ 17 Emergent BioSolutions ............................................................................ 19 MasterControl .......................................................................................... 33 Natoli Engineering Company, Inc. .......................................................... 29 Nelson Laboratories, Inc ......................................................................... 27 Renishaw, Inc. ........................................................................................... 23 SW Safety Solutions ................................................................................. 25 Veltek Associates, Inc ................................................................................ 5 Ad Index COMPANY PAGE

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