In Hong Kong, the Authorised Person (AP) must ensure that all legislative obligations are fully satisfied before any pharmaceutical product is released for sale or supply.

It is incumbent upon all APs to discharge their professional duties per the Code of Practice for Hong Kong Pharmaceutical Manufacturers and Authorised Persons. It is the responsibility of the AP to certify that a product has been manufactured following its registrable particulars and with Good Manufacturing Practice (GMP).

To become an AP, an individual must meet minimum qualification requirements and demonstrate relevant industry experience in Hong Kong or a country/region whose regulatory authority is a PIC/S Member Authority. In addition, every AP must provide evidence that they have undertaken at least 20 hours per year or equivalent of Continuing Professional Development (CPD) training approved by the Department of Health Hong Kong. A registered AP should fulfil the requirements every year for their registration to be renewed.

The Pharmacy and Poisons (Manufacturers Licensing) Committee (the "Committee")* has approved the following range of courses submitted by SeerPharma to be part of Hong Kong’s CPD program for AP’s.

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SCHEDULE

Click a course title below for more information and registration details.

 Course  CPD Hours 2023 Dates  Course Code
 GMP - What You Need to Know  14  February 13-14  CPD/O/01/2021
 Quality Risk Management  14  March 06-07  CPD/O/02/2021
 Product Quality Review - Principles & Practices  14  March 20-21  CPD/O/03/2021
 Cleaning Validation  14  April 03-04  CPD/O/04/2021
 Process Validation  14  April 20-21  CPD/O/05/2021
 Validation - A Roadmap to Get it Right First Time  14  May 15-16  CPD/O/06/2021
 Managing Internal Audits and External Audits  14  June 13-14  CPD/O/07/2021
 Solid Dose Manufacturing  14  July 03-04  CPD/O/08/2021
 Computer System for Regulated Environment & Data Integrity  14  August 14-15  CPD/O/09/2021
 Supply Chain Management & Supplier QA Program  14  September 25-26  CPD/O/10/2021
 Root Cause Analysis and CAPA  14  October 16-17  CPD/O/11/2021
 Behavioural GMP - Minimising Human Error  14  November 20-21  CPD/O/12/2021

 

 * Recognition of CPD activities falls under the ambit of the  Committee , an executive committee of the Pharmacy and Poisons Board (the "Board"). The list of CPD training activities approved by the Committee and their providers is available on the website of the Board (www.ppbhk.org.hk) and the Drug Office of the Department of Health (www.drugoffice.gov.hk) for viewing by the public.

Details of the requirements for CPD can be found in the "Guidance on Qualificaiton, Experience and Training Requirements for Authorized Persons and Other Key Personnel of Licensed Manufacturers in Hong Kong" published by the Board which can also be downloaded from the websites above.

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