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.
Click a course title below for more information and registration details.
|Course||CPD Hours||2022 Dates||Course Code|
|GMP - What You Need to Know||14||21-22 March||CPD/O/01/2021|
|Quality Risk Management||14||07-08 April||CPD/O/02/2021|
|Product Quality Review - Principles & Practices||14||21-22 April||CPD/O/03/2021|
|Cleaning Validation||14||05-06 May||CPD/O/04/2021|
|Process Validation||14||16-17 May||CPD/O/05/2021|
|Validation - A Roadmap to Get it Right First Time||14||26-27 June||CPD/O/06/2021|
|Solid Dose Manufacturing||14||18-19 July||CPD/O/08/2021|
|Managing Internal Audits and External Audits||14||25-26 July||CPD/O/07/2021|
|Computer System for Regulated Environment & Data Integrity||14||03-04 August||CPD/O/09/2021|
|Supply Chain Management & Supplier QA Program||14||12-13 September||CPD/O/10/2021|
|Root Cause Analysis and CAPA||14||10-11 October||CPD/O/11/2021|
|Behavioural GMP - Minimising Human Error||14||27-28 October||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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