Connecting Quality, Regulatory, and Manufacturing Data is Key to Improving Supply Chain Agility
For more than 15 years, shortages of critical and non-critical drugs [SL1] [MOU2] – from oncology treatments, emergency room and surgical suite essentials to antibiotics and flu medicine – have burdened the healthcare systems and compromised patient care and outcomes. “The issue has become uncomfortably real for me recently, as I searched for a pharmacy that could fill my daughter’s amoxicillin prescription,” said Vicki Cookson, strategy director, Vault RIM, Enterprise at Veeva.” “How would I feel, I wondered, if I’d needed immediate access not to a common antibiotic, but a treatment for a life- threatening illness?”
Despite ongoing analysis and guidance, supply gaps continue, especially for generic drugs, which account for most of the medications prescribed in Europe and the United States. “For some generics manufacturers, margins in the low single digits can make consistent quality and compliance a challenge,” said Sofia Lange, strategy director, quality & manufacturing at Veeva. “The costs of not addressing quality can drive a small supplier out of business, further shrinking supplies.”
Lack of Data Transparency, on The Macro and Micro Level
Lack of data transparency across the supply chain is a core challenge for regulators and suppliers of all sizes. It prevents insights into supply fluctuations and their root causes. Decreased access to global compliance and quality data for the active pharmaceutical ingredients (APIs) and finished drugs manufactured offshore has only compounded supply risks. Between 2020 and 2022, FDA’s five-year backlogs for offshore API facility inspections have increased from 30% to 80%, and the agency is pivoting to remote and other inspection formats.
“Regulators, governments, patient advocates, and industry groups are actively working to solve today’s supply problems. By listing the generics most vulnerable to shortages, the European Medicine Agency has taken an essential first step, which should help guide future efforts,” said Cookson. So far, discussions of next steps have emphasised the need for economic incentives, to help generics manufacturers update manufacturing, and to speed better approaches to supply chain data collection, monitoring, and analytics.
Meanwhile, at the “micro” level, at the individual facility and company, there is a new focus on establishing data transparency and connecting data across functions. Data-driven approaches are helping more companies reduce the risk of shortages by improving the efficiency of compliance and quality operations.
Connecting Cross-functional Data for More Agile Change Control
One area of focus is improving post-approval process change control, a time and labour intensive behind-the-scenes process that often leads to supply delays. Using traditional approaches, with disconnected data, separate IT systems, and manual processes, a single change control process can take from six months to two years to complete. Depending on the regulatory agencies and regional requirements involved, the work required can delay a drug’s availability by up to five years. Today, a typical large biopharma company manages 40,000 of these applications each year, with up to 200 for a single product.
