Q338 · What key terms should be included in the…

Q338 · Category G: Quality management and compliance systems (Q301–Q350)

A quality agreement is a legal document that clearly defines and divides the specific responsibilities of you, as the licensed wholesaler, and your outsourced service provider for activities related to GDP. It is not a commercial contract and does not cover prices; it deals only with quality and compliance responsibilities. A detailed quality agreement should include at least the following core terms: 1. The scope of each party’s responsibilities, clearly stating who does what; 2. Requirements for personnel qualifications and training; 3. Requirements for facilities and equipment, such as vehicle requirements and calibration of temperature-control equipment; 4. Key operating procedures, such as handover, temperature control and security; 5. Requirements for data recording and sharing, such as provision of transport temperature data; 6. Joint procedures for handling and investigating deviations; 7. A mechanism for notification and approval of changes; 8. Your right to audit the service provider; 9. Joint procedures for handling complaints, returns and recalls; 10. Confidentiality arrangements and the term of the agreement.

📘 Regulatory basis

Chapter 7, “Outsourced Activities”, of the Good Distribution Practice (GDP) for Medicinal Products expressly provides that all outsourced activities must be covered by a written contract (with the quality agreement being the most important part). The contract should clearly define each party’s responsibilities, particularly those relating to quality.

📗 Drew Tang's recommendations

When drafting a quality agreement, ensure that your quality department and legal adviser are both involved. The agreement should be as specific as possible and avoid vague language. For example, do not simply state ‘temperature must be maintained’; specify ‘temperature must be maintained between 2°C and 8°C, with temperature records provided for the entire period’. A quality agreement should be treated as a ‘living document’ and updated promptly when the business relationship or regulatory requirements change.

📕 Risk notice

Without a quality agreement, or if its terms are ambiguous, it will be extremely difficult to allocate responsibility if a problem arises, which can lead to disputes. For example, if the temperature of a batch of cold-chain medicines exceeds limits during transport, without an agreement defining the carrier’s responsibilities and data-provision obligations, it will be difficult to hold the carrier accountable and conduct an effective investigation. In the regulator’s view, this amounts to outsourcing quality responsibility without effective control.

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.

What key terms should be included in the Quality Agreement with my carrier or third-party warehousing service provider?

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang