The pharmaceutical industry is dynamic. Sophisticated research & development and constant innovation in balance with strict regulatory compliance and end-user affordability/accessibility drive growth — but they also present challenges.
Trends in the pharmaceutical space suggest a new year with some old obstacles. As needs and regulations change, toll processing in pharmaceuticals is finding a new presence in helping pharma companies overcome hurdles in supply chain management and quality control.
In 2023, 53% of global pharmaceutical companies continue to struggle with supply chain issues that interfere with ingredient acquisition.1 What’s more, 25% report a lack of visibility into supplier risks which creates vulnerabilities around quality control and potential counterfeit medication production.1
Closer to home, changes to the US FDA Drug Quality & Security Act — specifically Title II, the Drug Supply Chain Security Act (DSCSA) — impact product traceability requirements. The shift from interoperable, electronic tracing from lot level to package level enables pharma companies to ‘provide, receive and maintain documentation about prescription drugs and their chain of ownership from manufacturer to dispense as the drugs are distributed in the U.S. supply chain.”
In other words, DSCSA changes enacted in November 2023 are intended to optimize consumer safety. The legislation also loops in wholesale distributors, third-party logistics providers, and other supply chain entities through newly required national licensure standards — a layer of quality control and additional protection for U.S. consumers.
Pharmaceutical companies face competing priorities in product legislation, production, and distribution. The complexities make it more crucial than ever to strategically align with toll processing partners with proven track records in quality control and supply chain management.
Working with a full-service toll processor such as CPS fits the bill. Our expertise, capabilities, and breadth of experience in particle technology for drug manufacturing ensures materials entrusted to us can be:
Toll processing in pharmaceuticals has always been critical. However, as trends and legislation point to changes — and sometimes challenges — within the industry, a toll processor needs to be a true partner to pharma companies.
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SOURCE
1Master Control, 2023 Pharma Quality Trends: 4 Ways Pharma Quality is Changing, 2023.