Q89 · As a licensed “manufacturer”, may I outsource…

Q89 · Category B: Licence types and scope of application (Q51-Q100)

Yes. This is very common in the pharmaceutical industry and is known as “contract manufacturing” or “contract analysis”. As a licensed manufacturer, you may outsource one or more steps in the manufacturing process, such as raw material testing, intermediate product manufacturing, finished product testing, stability studies or packaging, to another organisation that also holds a valid manufacturer’s licence and has the relevant GMP capability (the “contract acceptor”). However, as the party that places the product on the market (the “contract giver”), you remain fully responsible for the final quality of the product.

📘 Regulatory basis

Chapter 7 of the GMP Guide, “Contract Manufacture and Analysis”, sets out the responsibilities and obligations of both parties to a contract in detail. The key document is a comprehensive “Quality Agreement”, which must clearly define each party's specific responsibilities for production and quality control.

📗 Drew Tang's recommendations

Before selecting a contract partner, you must conduct rigorous qualification checks to ensure that they can meet your quality and regulatory requirements. It is essential to draft a robust quality agreement setting out in detail all relevant matters, including how materials will be transferred, how records will be handed over, what the inspection criteria are and how deviations will be handled. We can assist you with supplier audits and drafting quality agreements.

📕 Risk notice

Outsourcing does not mean outsourcing responsibility. If your contract laboratory issues an incorrect test report that results in a batch of non-conforming products being released to the market, you, as the commissioning party and final AP, may bear primary legal responsibility. You must therefore retain the right to supervise and audit the contractor.

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.

As a licensed “manufacturer”, may I outsource some manufacturing operations, such as quality testing, to another licensed institution?

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang