Best Practices for Supplier Qualification in Life Science

Supplier qualification and audits have become increasingly vital in the quality systems of pharmaceutical, biotechnology, and medical device manufacturers.

Regardless of the material or service procured, ensuring suppliers consistently meet quality requirements is paramount. Regulatory agencies like FDA, EMA, MHRA, TGA, PIC/S, and ISO 13485 have intensified focus on supplier qualification. Notably, the 2015 update of the EU GMP Guide emphasized supplier selection and qualification in Chapter 5. This marked the first mention of "QUALIFICATION" in the GMP Guide. The revised chapter delineates separate requirements for APIs and Excipients.

While the concept of qualifying suppliers may have been unfamiliar decades ago, it is now integral to industry practices. Qualifying suppliers, particularly those in China and India, presents significant challenges, necessitating additional responsibilities for both parties. However, supplier qualification extends beyond audits; successful "Quality Agreements" are crucial. Before outsourcing, companies must define minimum product specifications and user requirements, ensuring compliance with GMP. Each product may have specific requirements, necessitating thorough evaluation during initial technical visits to potential suppliers. Assessing SOPs, Quality Management Systems, previous audits, organizational structure, and task distribution aids in preliminary evaluation.