What key steps should be taken when conducting an initial qualification check of a new medicine supplier?

Initial qualification of new suppliers is the first safeguard for ensuring that your supply chain is lawful and compliant at source, and must be conducted with great care. Key steps include: 1. **Document review**: Ask the supplier for a complete set of qualification documents, including its business licence, medicines trading licence (such as a wholesale licence) and, where applicable, the manufacturer’s GMP certificate. Verify that these documents are authentic and valid. 2. **Questionnaire**: Send the supplier a detailed quality system questionnaire to understand its QMS, including its personnel, facilities, SOP system, temperature-control capabilities and recall procedures. 3. **Risk assessment**: Use the document review and questionnaire results to conduct an initial assessment of the supplier’s potential compliance risk. 4. **On-site audit (for high-risk suppliers)**: For critical, high-risk suppliers—for example, the sole supplier from which you plan to source a core product—an on-site audit is strongly recommended to verify in person that its operations match the documents. 5. **Approval and agreement**: Only after all review steps have been completed satisfactorily should the supplier be added to the “Approved Supplier List” and a formal quality agreement signed.