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How should we qualify and manage our suppliers of medicines or raw materials?

A complete explanation of the regulatory basis, Drew Tang’s recommendations and risk alerts. The original material dates from 2025; read it alongside the latest official requirements.

Original guide, 2025 edition: These FAQs are provided for topic-based reference and have not all been individually checked against current rules. Please confirm fees, personnel, renewal, changes and product requirements against the professional in-depth guide for the relevant licence type and the official requirements in force at the time.

Drug Office, Department of Health Chinese Medicines Board

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.

📘 Regulatory basis

Both the Code of Practice for Licensed Wholesale Dealers and GMP guidance require licensees to ensure that they procure medicines or raw materials only from approved suppliers, and to have procedures for supplier qualification and management.

📗 Drew Tang's recommendations

We recommend classifying suppliers by risk. On-site audits are almost essential for suppliers of key active pharmaceutical ingredients (APIs). Suppliers of lower-risk materials, such as packaging materials, can be assessed through document review. Do not rely entirely on suppliers’ GMP certificates; particularly in high-risk areas, conducting an audit yourself or commissioning a third party to do so will give you a more accurate understanding. Rengangyongsheng (Hong Kong) Limited provides professional supplier audit services.

📕 Risk notice

Purchasing medicines or raw materials from unapproved suppliers is a serious GDP/GMP breach. It compromises the assurance of product origin and prevents effective traceability. If a supplier’s materials have quality issues that result in non-conforming finished products, you will bear full responsibility. In the eyes of regulators, selecting an unqualified supplier is equivalent to deliberately introducing risk into your system.

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