Q329 · How can I ensure the security of my medicine…

Q329 · Category G: Quality management and compliance systems (Q301–Q350)

Supply chain security is an increasingly important aspect of GDP, intended to protect medicines in distribution from theft, tampering or the introduction of counterfeit products. This requires a multi-layered security strategy. At your storage facilities, implement strict access controls so that only authorised personnel can enter medicine storage areas; install CCTV and intrusion alarm systems; and store high-value or controlled medicines in areas with additional security measures, such as safes or locked cages. During transport, use vehicles or containers that can be sealed and show signs of tampering; choose reputable transport partners and conduct background checks on their drivers; and consider GPS tracking for high-risk shipments.

📘 Regulatory basis

The Good Distribution Practice (GDP) for Medicinal Products requires appropriate measures to prevent unauthorised persons from entering storage areas. It also requires medicines to be protected from theft and tampering during transportation. Together, these requirements form the basic provisions for supply chain security.

📗 Drew Tang's recommendations

Conduct a comprehensive security risk assessment to identify the weakest points in your supply chain. Do not overlook the risk of internal theft; establish clear stocktaking and reconciliation procedures. Specify each party’s security responsibilities in quality agreements with carriers. Train your staff to check incoming goods for signs of tampering.

📕 Risk notice

The theft of medicines is not only a financial loss but also a public safety issue, as stolen medicines may enter the market through illegal channels, with no assurance of their quality. If the regulatory authority considers your security measures to have major gaps that led to the theft of medicines, you may be penalised for failing to fulfil your duty to protect them.

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 I ensure the security of my medicine supply chain and prevent theft or tampering?

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang