As a clinical startup, establishing a supplier management program and managing supplier relationships is critical to ensuring the quality, safety, and efficacy of clinical products and therapies. A supplier management program defines the standards to evaluate, qualify, monitor, and requalify a company’s suppliers. This program is a holistic approach to ensuring your suppliers meet regulatory requirements and can consistently meet quality standards. The program should cover all suppliers providing materials, equipment, services, or systems essential for a company’s GxP activities. A well-structured supplier management program would incorporate the following as part of the supplier evaluation and qualification process:

Supplier Qualification and Evaluation

As part of the supplier qualification process, a comprehensive evaluation of the supplier is conducted. This involves assessing potential suppliers not only on their ability to meet regulatory standards but also on their overall experience in the biotech industry and their quality management systems. The following aspects are part of the evaluation:

  • Assessment: Classifying suppliers based on the risk their supplied material or service poses to product quality and patient safety. For example, suppliers can be categorized into minor, major, and critical risk levels, influencing the extent of oversight required.
  • Quality Agreements: Based on the criticality of the supplier, a quality agreement may be required. Quality agreements specify the quality and compliance standards expected from suppliers. These agreements should cover critical aspects like deviation handling, change control, and corrective and preventive actions (CAPA).
  • Supplier Audits: Based on the criticality of the supplier, supplier qualification audits are performed to verify compliance. Audits should evaluate production processes, quality control measures, and documentation practices. Findings from these audits help in making informed decisions about supplier status and improvement areas.

Re-evaluation and Requalification

Following the approval of a supplier, the company must periodically evaluate that the supplier meets applicable internal and regulatory requirements. The approach used is based on the classification of the supplier and on the supplier’s performance. This process involves periodic reviews based on supplier performance and compliance status, ensuring that only qualified suppliers remain on the approved list.

Disqualification of Suppliers

As part of the supplier management program, a process must be defined for handling the rejection of approved suppliers, the disqualification of potential suppliers, and the requalification of suppliers who were previously disqualified, as applicable.

At Assurea, we support clinical startups with development of their supplier management program as well as perform supplier qualification audits on behalf of our clients. Learn more about our services!