Last year's heparin tragedy was caused by multiple quality breakdowns in the supply chain, from the sourcing of pure heparin to inadequate product testing and supplier oversight. The breakdowns occurred under the watch of the active pharmaceutical ingredient (API) manufacturer, the contract manufacturer, the sponsor company, and even the US Food and Drug Administration (FDA). Regardless of who may have "failed" in performing their responsibilities, it is the sponsor company that carries ultimate responsibility for the quality of the product and liability for the consequences to patients.
Ensuring product quality should not rely only on certifications by suppliers or inspections by the FDA. To ensure product quality, sponsor companies must follow a three-pronged approach to managing their supply chains: "validate, verify, and implement."VALIDATE
Is the entire manufacturing, software, and quality system capable of protecting product quality and compliance? Validation should be conducted for the entire supply chain to confirm that all interrelated systems are properly designed, installed, calibrated, maintained, and tested to ensure consistent operation and performance. Recent examples of failures focus on the lack of consistent test procedures or laboratory control mechanisms, calibration of manufacturing equipment, and the accuracy of output from computer or production systems.
Does each link in the supply chain have the necessary procedures in place to fulfill its quality and compliance responsibilities? Standard operating procedures (SOPs) are the basis of good manufacturing practice, yet poor or nonexistent SOPs are often the subject of 483s and warning letters from the FDA. All SOPs, policies, and written procedures must be verified. Testing procedures must be verified to ensure that any failure in one part of the supply chain will be identified and corrected where it occurs. Breakdowns in procedures, and the inability to identify those breakdowns quickly, are at the root of most compliance violations and product quality issues.
Are the systems being operated according to SOPs and corporate policy? SOPs and policies are useful only if people are able to effectively implement them. Have employees (not only those of subcontractors, but also of their subcontractors) been properly trained? Have knowledge gaps been identified and closed? Can each member of the supply chain demonstrate compliance with not only regulatory requirements, but also the sponsor company's code of conduct, ethical standards, and compliance responsibilities?
Ensuring product quality becomes more difficult by the day as supply chains extend into new parts of the world and subcontractors release work to a growing network of small, often hidden, providers. It is our responsibility as professional managers overseeing the development and distribution of drugs to the public to vigilantly focus on quality, consistency, and positive patient outcomes, regardless of the size and complexity of the supply chain.
Ellen Leinfuss is a senior vice president at Kaplan EduNeering, Princeton, NJ, 609.627.5300, ELeinfuss@kaplan.com