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Analytical & Advisory Services Division

Pharmaceutical Chemistry Section

[ About the Section | Responsibilities |
  Quality Assurance | Key Instruments | Targets and Key Indicators ]
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About the Section

Pharmaceutical Samples
Pharmaceutical samples

This Section examines pharmaceutical items for compliance with national pharmacopoeial standards, such as the British Pharmacopoeia and the United States Pharmacopoeia. Majority of the tests carried out are chemical testing. Starting from April 2002, the newly established Microbiological Unit of the Section provides centralized microbiology testing services to the Laboratory.

 

 

 



Responsibilities

This Section conducts analyses for enforcement of the following Ordinances:

  • The Pharmacy and Poisons Ordinance
  • The Antibiotics Ordinance

In addition, the Section analyses pharmaceutical products, which are submitted by the Department of Health and the Hospital Authority, to check on the compliance with specifications.


Quality Assurance

About 20% of the tests conducted in the section are for QC purpose.


Key Instruments

Ion mobility mass spectrometer
Ion mobility mass spectrometer

The following instruments are used routinely by the Section:

  • Liquid Chromatography with High Resolution Mass Spectrometer (LC-HRMS)
  • Liquid Chromatography with Tandem Mass Spectrometer and Electron Transfer Dissociation (LC-MS/MS ETD)
  • Liquid Chromatography with Tandem Mass Spectrometer (LC-MS/MS)
  • Matrix-Assisted Laser Desorption Ionization Time-of-Flight Mass Spectrometer (MALDI-TOFMS)
  • High Performance Liquid Chromatography with various detectors
  • Gas Chromatography with various detectors
  • Fourier Transform Infrared spectrometer
  • UV Spectrophotometer
  • Fluorescence Spectrophotometer
  • Capillary Electrophoresis System
  • Disintegration Tester
  • Dissolution Tester
  • Density Meter
  • Flow Injection Analyzer

 

 

 


Targets and Key Indicators

Key Performance Measures Relating to the Statutory Testing of Pharmaceuticals

Targets #

Testing of Pharmaceuticals Targets 2019
(Actual)
2020
(Actual)
2021
(Plan)
Urgent samples relating to pharmaceutical incidents within two working days (%) 95 100 100 95
Other pharmaceutical samples within reporting time averaging 25 working days (%) 95 99 98 95

For targets where reporting time is mentioned, different samples require different analytical procedures, hence different reporting time. The quoted number of working days required represents an average of reporting time for the different types of samples and test requests within the category, while the target (in percentage) is the total compliance rate of the concerned samples and test requests within a particular category against their respective targets.

Key Indicators

Key Indicators for Statutory Testing of Pharmaceuticals

Tests Performed on Pharmaceuticals 2019
(Actual)
2020
(Actual)
2021
(Estimate)
Urgent samples relating to pharmaceutical incidents 6 156 N.A.
Other pharmaceutical samples 51,562 51,467 51,000

As the testing requirements for urgent samples relating to food, pharmaceuticals and Chinese medicine incidents fluctuated in previous years, it is difficult to estimate either the occurrence of these type of incidents or the number of tests required.