Q309 · How can business partners in the supply…

Q309 · Category G: Quality management and compliance systems (Q301–Q350)

Under GDP principles, a medicine wholesaler’s quality responsibilities do not end when certain activities, such as transport or storage, are outsourced. You must rigorously qualify and continuously monitor the performance of all partners involved in your supply chain. Before selecting a transport company, you must conduct due diligence to confirm that it can meet the specific requirements for transporting medicines, particularly medicines requiring cold-chain transport. The parties should sign a detailed Quality Agreement setting out their respective responsibilities for temperature control, security, handover procedures and emergency response. You should regularly review the transporter’s performance, for example by inspecting its vehicles, temperature-control equipment calibration records and temperature data during transport.

📘 Regulatory basis

Chapters 9, “Transportation”, and 7, “Outsourced Activities”, of the Good Distribution Practice (GDP) for Medicinal Products set out clear requirements on this. Licensees must control outsourced activities to avoid any adverse impact on the quality of medicines. All outsourced activities must be covered by a written contract clearly defining the responsibilities of each party.

📗 Drew Tang's recommendations

Do not choose a transport partner based on price alone. We recommend maintaining an Approved Supplier/Vendor List. Before adding any transport company to the list, conduct an on-site assessment and request relevant SOPs and training records. Quality agreements should be as detailed as possible and cover all foreseeable scenarios. For cold-chain transport, require the carrier to provide complete temperature records for each shipment, for review by your quality department.

📕 Risk notice

If your transport partner makes an error during transit (such as a break in the cold chain) that compromises the quality of the medicines, you, as the licensed wholesaler, will ultimately bear the legal and reputational responsibility. During a regulatory inspection, if you cannot provide evidence of effective management of the transport provider (such as qualification checks, quality agreements and performance evaluation records), you will be considered to have failed to fulfil your GDP responsibilities. This is a serious compliance deficiency.

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.

How can business partners in the supply chain (such as transport companies) be effectively qualified and managed in pharmaceutical wholesale operations?

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang