SeerPharma Launch Approved GMP Training Programs for AP’s in Hong Kong

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).

The AP must be aware of any information, incidents or deviations which may influence their decision to certify whether a batch is suitable for release for sale. AP’s should have a thorough understanding of the following:

• The routine legal duties of an AP, the level of oversight required; including detailed knowledge on the principles and application of ‘risk management’ within the pharmaceutical industry;
• Batch review and decision making on the disposition of batches of pharmaceutical products, i.e. whether to release for sale or, in the case of non-compliant or defective material to decide on its rejection or rework/reprocessing;
• The key factors, information or metrics that confirm a batch of pharmaceutical product has a suitable pedigree demonstrated throughout the manufacturing supply chain and has been manufactured according to current PIC/S GMP requirements;
• The principles and practice of current GMP and Quality Assurance (QA) as given in the current PIC/S Guide to GMP, including related Hong Kong legislation;
• The conduct and obligations of holders of a manufacturer licence and registration certificates for pharmaceutical products;
• The preparation for and management of regulatory GMP inspections;
• The tools and methods used for risk management and their interface with regulatory requirements;
• The requirements for APs when acting as independent contractors or on behalf of third parties.

Both the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (“PIC/S Guide to GMP”) and the Hong Kong Guide to Good Manufacturing Practice for the Secondary Packaging of Pharmaceutical Products require that products are not sold or supplied before an AP has certified that each batch has been produced and controlled in accordance with the requirements of the marketing authorisation and any other regulations relevant to the production, control and release of the products.

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.

In December 2021, the Department of Health Hong Kong approved a range of courses submitted by SeerPharma to be part of Hong Kong’s CPD program for APs.

From March 2022, SeerPharma will begin offering the following approved courses to APs in Hong Kong to help ensure that they maintain their registration as AP’s with the Department of Health.

Initiatives such as this reaffirm SeerPharma's commitment to its mission of "Advancing Quality and GMP Best Practices in the APAC Region".