Authorized Person of Pharmaceutical Manufacturer

The local pharmaceutical manufacturing sector is a relatively small yet specialised area that pharmacists usually find less opportunities to break into. Our pharmacist community might not be familiar with the career ladder in this sector and due to this, pharmacy graduates might have missed out some great career opportunities available. Today, we would like to introduce you the role of Authorized Person in a pharmaceutical manufacturer, who is usually seen as the “Quality Head” of a manufacturing facility to safeguard the quality of the produced medicines.

Role of Authorized Person of Pharmaceutical Manufacturer

An Authorized Person of Pharmaceutical Manufacturer (AP) has the responsibility to certify every batch of pharmaceutical products to be released into the market for sale. The AP has to ensure that the released pharmaceutical product has been manufactured in a licensed local manufacturer according to PIC/s GMP requirement and has met the requirements of the registered product particulars. The professional term “Authorized Person” in HK is equivalent to the term “Qualified Person” adopted in EMA.

AP Qualification

An AP is generally a registered pharmacist with a minimum of 3 years of experiences in the manufacturing or quality control area of a pharmaceutical manufacturer, or equivalent. For the more detailed qualification requirements and registration process of AP, please visit the Drug Office website. It shall be noted that a registered AP shall meet the obligations and requirements highlighted in the code of practice document.

Functions in GMP Structure

In Hong Kong, an AP normally oversees the three major GMP functions in a manufacturing facility, namely Quality Assurance, Quality Control and Production. Other GMP supporting functions such as warehousing, procurement and engineering can also be supervised by the AP. With the responsibility to lead and drive such cross-functional matrix, an AP requires an exceptionally good people management and operation skills on top of his or her quality expertise. He or she has to directly and indirectly manage around 50 to 200 staff in the facility, depending on the company organisational hierarchy, scale of manufacturing plant and scale of business.

A Day of AP

8:30am – Approve the quality documents received from Production and QA Department, an operation and cleaning SOP of a newly qualified equipment and a cleaning validation protocol and report of the oral solid dosage equipment train

9:30am – Head to the production floor and look at the installation of a new granulation mixer located in a Grade C Cleanroom Area, casually walk through the solid dosage manufacturing section to keep track on the operation and documentation quality status

11:00am – Catch up with the regulatory affairs pharmacist on the progress of a number of change of registered particulars applications, review on supplementary quality documents to be submitted to Department of Health

12:00nn – Briefly meet up with the engineering department and discuss about the upcoming maintenance and calibration plan of utilities and facilities

1:00pm – Lunch out with QA Manager and Summer Interns

2:00pm – Follow up on corrective actions in response to the identified deficiencies from the last regulatory inspection

3:30pm – Hold meeting with GMP team to follow up on the renovation of warehouse and to monitor the implementations according to change of particulars proposal

5:00pm – Approve the batch production records of several medicinal products and coordinate with logistic team on the release and distribution of products

7:00pm – Review purchase orders. Prepare monthly operation report for the production schedule, manpower plan, inventory and throughput level.

Insider Comments about AP

Q: How to equip yourself to be an AP?

A: On top of your professional and clinical knowledge on medicines, I think leadership skill and operation knowledge are essential to make you an excellent Authorized Person. In the manufacturing business unit, you have to engage with various parties and co-workers from a diversified background such as process engineers, sales & marketing, human resources and operation management to solve problems and drive product quality.  To develop the mentioned attributes, further professional learning and related work experience are generally required as you may not be able to gain them from your pharmacy course at University. Try to broaden your scope of learning but not just limit yourself inside the frame of pharmacy. Always network, Google and read.

 

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