Q332 · Beyond initial qualification checks, how…

Q332 · Category G: Quality management and compliance systems (Q301–Q350)

Supplier management is an ongoing process, not a one-off approval activity. Initial qualification is only the starting point; ongoing performance management and periodic re-qualification are equally important. Performance management should be based on a range of key performance indicators (KPIs), such as on-time delivery rate, order accuracy, temperature excursion rate during transport, product damage rate, and efficiency in responding to complaints and enquiries. You should compile this data regularly (for example, quarterly or annually) into a supplier performance report. Use the report and risk assessment to grade suppliers (for example, “excellent”, “qualified” or “requires improvement”). For critical suppliers, conduct regular on-site audits or request up-to-date compliance documents as part of the re-qualification process.

📘 Regulatory basis

The Good Distribution Practice (GDP) for Medicinal Products requires ongoing monitoring of suppliers both before and after approval. You must demonstrate that the medicines you procure consistently come from approved suppliers that comply with GDP requirements. This entails a responsibility to supervise suppliers on an ongoing basis.

📗 Drew Tang's recommendations

Build strategic partnerships with your key suppliers, hold regular quality meetings, share performance data and discuss improvement opportunities together. Set out your expectations clearly in quality agreements. A formal supplier management procedure not only reduces supply chain risks but also improves the efficiency and quality of the entire supply chain through incentives and collaboration.

📕 Risk notice

Failing to monitor existing suppliers on an ongoing basis is a common oversight. A supplier that was once qualified may see its quality system deteriorate over time. If you cannot provide evidence of ongoing supplier oversight, you may be held jointly liable for failing to discharge your supervisory responsibilities if that supplier has a serious quality problem. Relying on a qualification assessment document from several years ago is far from sufficient.

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang

Business Manager Tang Shangyong (Drew Tang) will review your products, operating model, licence type and preparation requirements with you one-to-one. The precise service scope is confirmed in writing; pharmaceutical duties are carried out by legally qualified personnel, and approvals are determined by the competent authorities.

Beyond initial qualification checks, how should existing suppliers be subject to ongoing performance management and reassessment?

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang