Q376 · Category H: Licensed operations and routine regulatory oversight (Q351–Q400)
Supplier management is key to ensuring quality at the start of the supply chain. You should not choose a supplier solely because of its low prices. A sound supplier management procedure should include: 1. Initial assessment and selection: before choosing a new supplier, you must assess its qualifications. This may be done through questionnaires, by requesting evidence of qualifications (such as a manufacturing licence or GMP certificate), or by conducting an on-site audit. Assess its quality management system, manufacturing capacity, compliance history and other relevant factors. 2. Approval and agreements: only suppliers that have passed the assessment may be added to the Approved Supplier List. For suppliers of critical materials, a Quality Agreement should also be signed to define the quality responsibilities of both parties. 3. Ongoing monitoring: continuously monitor supplier performance, for example through indicators such as the acceptance rate of incoming goods, on-time delivery and response times to complaints. 4. Periodic reassessment: reassess suppliers periodically (for example, every 1–3 years, depending on risk level) to ensure that they continue to meet your requirements. Suppliers with serious quality issues or consistently poor performance should be removed from the Approved Supplier List.