Q78 · What role does the “Authorised Person” (AP)…

Q78 · Category B: Licence types and scope of application (Q51-Q100)

The “Authorised Person” (AP) is a critical statutory position at a pharmaceutical manufacturer and the final safeguard for medicine quality. Under GMP requirements, every batch of medicine manufactured must undergo a final review and be signed off for release by an AP before it can be sold. The AP must independently review all relevant records for the batch, including manufacturing records, environmental monitoring data and quality control laboratory test reports, to confirm that the entire manufacturing and testing process complies with GMP requirements and product registration standards. The batch may only be lawfully placed on the market after the AP has confirmed that everything is in order and signed off. The AP must have professional qualifications in pharmacy or a related scientific field, as well as substantial pharmaceutical manufacturing experience.

📘 Regulatory basis

The Hong Kong Good Manufacturing Practice (GMP) Guide for Pharmaceutical Products sets out clear and stringent requirements for the duties, qualifications and independence of an “Authorised Person”. The appointment of an AP requires approval from the Department of Health. This concept derives from EU GMP regulations and is an internationally recognised practice.

📗 Drew Tang's recommendations

The AP bears substantial personal and legal responsibility for the quality of pharmaceutical products. The person selected for this position must therefore be a highly respected expert within the company, with outstanding professional competence and the courage to uphold principles. For small and medium-sized pharmaceutical manufacturers, finding and hiring a qualified and experienced AP may be a major challenge. RGYS may assist with clarifying roles, evidence of qualifications and responsibility arrangements within the written scope; the suitability, appointment and actual presence at work of candidates remain subject to verification by the applicant and legally qualified personnel, and no provision or certification of personnel is promised. RGYS may assist with clarifying roles, evidence of qualifications and responsibility arrangements within the written scope; the suitability, appointment and actual presence at work of candidates remain subject to verification by the applicant and legally qualified personnel, and no provision or certification of personnel is promised.

📕 Risk notice

The AP's decisions are independent and must not be subject to pressure from production or commercial interests. If the AP considers the quality of a batch questionable, they have the right (and responsibility) to refuse its release, even if this causes the company substantial commercial loss. Management pressuring the AP to release non-conforming products constitutes a serious breach of GMP and may result in the manufacturer's licence being revoked.

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 role does the “Authorised Person” (AP) play in a licensed pharmaceutical product “manufacturer”?

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang