How Trends Are Changing Toll Processing in Pharmaceuticals

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.

What’s happening in pharma 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.

Why the right toll processing partnership is imperative

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:

• Processed to the highest quality standards and yield. As the architects of what’s possible, CPS is the go-to toll processor for many pharmaceutical companies. The reason is simple: we don’t back down from challenges, and we don’t settle. Our experts are committed to providing precise results that meet or exceed quality specs in pharmaceutical blending and milling. Plus, we understand what it means to make the most of high-value materials by returning maximum yield on every product trial and production cycle — a valuable benefit for pharma customers facing supply chain delays or intermittent ingredient availability
• Repacked, labeled, and direct-shipped to your customers, all to your exact specifications. Being able to rely on the same certified tolling partner that processed your materials to repack them — either as part of a project or on a stand-alone basis — can alleviate many concerns around tracking and traceability. CPS offers package personalization (including stenciling and labeling) and direct shipment from our factory to your customers. Our equipment and techniques include automated bagging; paper or paper with polyethylene barriers; super sacks; drums; gaylord boxed; pails; stretch wrapping; and, customer or CPS-supplied packaging
• Warehoused, transported, and distributed without logistical complications. With facilities geographically located near major U.S. transportation routes, CPS can offer seamless logistics to get your product where it needs to go. Warehousing and transportation services managed by CPS gives pharma companies a break from finding, vetting, and aligning distribution providers that can adhere to timelines and other requirements

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.