USP’s supplier qualification standard became official on Aug. 1, providing a framework for vetting, approving, and monitoring suppliers of pharmaceutical materials and services, thereby strengthening the integrity of global supply chains and helping to ensure the availability of quality medicines that patients need worldwide. Using the principles in the new USP General Chapter <1083> Supplier Qualification to also qualify suppliers of raw materials, ingredients, and services for foods and dietary supplement ingredients can help safeguard the integrity of those supply chains as well.
Global supply chains are complex and vulnerable to disruption. They comprise interconnected webs of local and global ingredient suppliers, manufacturers, packagers, distributors, providers, and regulators. Disruptions in the global supply chains can jeopardize patient access to quality medicines, including widespread and long-lasting drug shortages, product recalls, price increases, and the increased potential for substandard and falsified medicines, all of which can result in reduced access and patient harm.
USP’s General Chapters–Packaging and Distribution Expert Committee developed <1083> to help mitigate these challenges and ensure quality—from product development to manufacturing and distribution—in support of supply chain resilience. This chapter emphasizes the importance of supplier qualification through a risk-based approach for selecting, assessing, approving, and monitoring suppliers of materials and services. While <1083> focuses on evaluating and establishing supplier reliability for pharmaceutical manufacturing companies and compounding pharmacies, its high-level elements of supplier qualification can also be applied to suppliers of foods and dietary supplement ingredients.
“General Chapter <1083> is an important addition to USP’s portfolio of quality standards and solutions that support a more resilient supply chain of quality medicines, foods, dietary supplements, and their ingredients,” summarized USP’s Desmond Hunt, Senior Principal Scientist, Science–General Chapters.
Supplier Qualification Life Cycle
The chapter’s centerpiece is the Supplier Qualification Life Cycle, a quality risk-based approach for selecting, assessing, approving, and monitoring suppliers of the following:
- Materials (e.g., active ingredients, excipients, other raw materials)
- Packaging materials (e.g., ampules, bottles, labels, cartons, shipping containers, desiccants)
- Services (e.g., contract manufacturing, packaging/repackaging, warehousing and transportation, software applications, calibration and qualification services, analytical services)
The Supplier Qualification Life Cycle provides a multi-step process for systematically evaluating and establishing supplier reliability based on the following:
- Risks to the quality of products or services
- Compliance with applicable regulations and requirements of supply contracts and quality agreements
- Reliability of the supplier to avoid quality deviations and component or product shortages
The following provides a high-level summary of the steps and related tasks of the Supplier Qualification Life Cycle process:
- Preparation: A cross-functional team headed by a process owner identifies the material and service requirements, defines the final product attributes and performance, and aligns on the material criticality.
- Identification and selection of supplier for materials and services: The team establishes the supplier requirements and identifies a short list of potential suppliers for each material or service.
- Evaluation and acceptance: The team evaluates the list of suppliers based on a risk assessment of the materials and services to be supplied, initiates contract and quality agreement negotiations with the selected supplier, and establishes a continuously updated database of suppliers and their qualifications.
- Performance monitoring: The team evaluates the supplier’s performance at regular intervals and validates the supplier’s certificates, authorizations, and financial viability; unfulfilled key performance indicators are evaluated and preventive or corrective actions taken.
- Supplier disqualification: If a supplier no longer meets the approval criteria, the team should disqualify the supplier and remove it from the supplier list so long as these actions are thoroughly evaluated and documented to minimize the impact on product quality and supply disruption.
- Conditional approval of an existing supplier: If an existing supplier’s performance becomes unsatisfactory but their disqualification would adversely impact patient safety, the team and supplier should agree upon an action plan with criteria and timelines for improvement.
Assessing and Controlling Risks
General Chapter <1083> provides a table of key points to consider when assessing and controlling risks related to supply chain complexity. They include risks related to material availability, supplier capabilities, patient safety, and industry finances.
“Risk assessment and control should be integrated into supplier qualification, taking into account quality and patient safety. This risk assessment effort is not a one-time event but rather a periodic, recurring process for communicating and reviewing risks,” noted USP’s Horacio Pappa, Ph.D., Senior Director, General Chapters Global Science and Standards Division.
The risk assessment process aids in evaluating the potential impact of these risks on the finished products, third-party materials and services, and internal systems. General Chapter <1083> emphasizes that each company needs to develop priorities based on the impact risks pose to their stakeholders, including patients, the public at large, employees, as well as shareholders. When measuring impact, it is important to focus on safety, efficacy, and continuity of supply.
Having created quality standards for more than 200 years, USP has a unique lens into global supply chains. From raw materials to production, packaging, and distribution, USP standards enable consistency and uniformity in medicines, foods, and dietary supplements—no matter the company producing them or where they are produced. USP tools that allow increased data sharing and insights throughout the supply chains help manufacturers and regulators identify quality and supply concerns and mitigate risks earlier in the process. This builds public trust in medicines, foods, and dietary supplements.
