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.
This training program is restricted to Hong Kong APs only.
Click a course title below for more information and registration details.
|Course||CPD Hours||2023 Dates|
|Quality Risk Management||14||March 06-07|
|Product Quality Review - Principles & Practices||14||March 20-21|
|Cleaning Validation||14||April 03-04|
|Process Validation||14||April 20-21|
|Behavioural GMP - Minimising Human Error||14||May 15-16|
|Supply Chain Management & Supplier QA Program||14||June 13-14|
|Root Cause Analysis and CAPA||14||July 03-04|
|Computer System for Regulated Environment & Data Integrity||14||August 14-15|
|GMP - What You Need to Know||14||September 25-26|
|Managing Internal Audits and External Audits||14||October 12-13|
|Validation - A Roadmap to Get it Right First Time||14||November 20-21|
* 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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