A focus on quality should underpin everything life sciences companies do within their supply chain.
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A focus on quality should underpin everything life sciences companies do within their supply chain.
Having a diversified selection of vendors contributes to quality focus in the supply chain.
A quality supply chain can elevate operations and address interruptions like recalls or regulatory changes.
To successfully manage their supply chain, life sciences businesses must navigate a variety of complexities, from complying with ever-changing regulatory requirements to controlling costs. Successful businesses have one thing in common: prioritizing quality throughout their supply chain strategy.
“For biopharma and medtech companies, a focus on quality must underpin everything they do in their supply chain,” says Zachary Nelson, a manager in the life sciences practice at RSM US LLP. “Supply chains can be unpredictable given shifting economic conditions, access to raw materials and evolving regulatory requirements. Maintaining traceability from an inventory management perspective and creating the quality standards for procurement, receiving and dispositioning are the building blocks to supply chain scalability.”
What makes up a quality supply chain strategy? According to Joe Goldberg, a partner and national life sciences practice consulting leader at RSM, it starts with collaboration across all functions of the business.
“Collaboration and strong communication must be present throughout the cycle,” Goldberg says. “From the procurement team that works with vendors to the warehouse team that manages inventory, as well as the finance team with payments and returns, everyone must be on the same page. Supply chain should not be a siloed function in the business.”
A commitment to good manufacturing practice (GMP), the industry standard for quality assurance guidelines and regulatory compliance, is also critical. “GMP means that regulations are addressed, trading partners are qualified, risks are assessed and documentation is highly visible throughout the supply chain,” Nelson says.
Meeting the U.S. Food and Drug Administration’s computer service validation requirement is another layer of complexity, as a majority of companies manage their supply chain using an enterprise resource planning system. Validation activities must be conducted around supply chain activities to ensure quality and documented compliance in preparation for an FDA audit.
Likewise, having a diverse selection of vendors contributes to quality focus. Having a single-source supplier can expose biopharma and medtech companies to business disruption if that sole vendor can’t deliver raw materials when needed, says Nelson. Having multiple strategic sourcing provides options and allows companies to shift with the evolving needs of the business.
Nonmanufacturing supply chain needs in areas like research and development or office supplies could also fall under the quality umbrella. “Having a centralized procurement strategy enables responsible purchasing across departments as well as cost savings from approved suppliers that have already established a standard of quality,” Nelson says.
A quality supply chain can elevate a company’s operations, which in turn can help address a variety of business interruptions, like recalls or regulatory changes.
“Constant reform, like the Inflation Reduction Act, can create stress for companies,” says Goldberg. “The IRA puts pressure on pricing for biopharmas around drug costs, which trickles down to controlling costs within the supply chain, like costs of materials or shipping. Already having supply chain strategies in place keeps costs in check and adds visibility for companies to manage any changes efficiently.”
So, if quality is the answer, what should life sciences businesses do to achieve it in their supply chain? Here are some key considerations:
Regardless of an organization’s size or industry, strategic planning now will pay off to help companies prepare for the near future—and the next major disruption. See 5 steps for overcoming supply chain challenges to understand how other companies are preparing.