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Analytical & Advisory Services Division

Pharmaceutical Quality and Investigation Section

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

Pharmaceutical Items
Pharmaceutical Items

The Section was established on 3 May 2010 under the Other Scientific Service Group of Analytical and Advisory Division. Its major activities are to perform safety evaluation of pharmaceutical items, including proprietary Chinese medicines, on sale in the market for western medicines adulteration and coordinate urgent services to the Department of Health for drug’s related incidents.

 

 

 

 



Responsibilities

The Section will centralize all routine analytical works related to western medicines adulteration of proprietary Chinese medicines and other proprietary herbal medicines. The Section will also provide necessary analytical, investigatory and enforcement support to the Department of Health (DH) for urgent suspected poisoning cases concerning the consumption of products containing undeclared western drug ingredients. The Senior Chemist of the Section with the support from the Chemists of the Section will be the first contact point for drug’s related emergency incidents.


Key Personnel

Senior Chemist : Dr. W T Tang
(Tel. No.: 2319-8393 E-mail : [email protected])

Chemist
(E-mail address)
Tel. No.
Dr. Queenie K W Chan, Chemist
([email protected])
2319-8401
Dr. W S Chow, Chemist
([email protected])
2210-7016
Dr. L H Tong, Chemist
([email protected])
2319-8401


Quality Assurance

About 10% of the tests conducted in the Section are for QC purposes.


Key Instruments

HPLC-QTOF
HPLC-QTOF

The following instruments are used routinely by the Section:

  • High Performance Liquid Chromatograph — Ion Trap Mass spectrometer
  • High Performance Liquid Chromatograph — Tandem Mass Spectrometer
  • High Performance Liquid Chromatograph — Quadrupole Time of Flight Mass Spectrometer

 

 

 

 

 

 

 

 

 

 


Targets and Key Indicators

Working closely with the Chinese Medicines Section and the Pharmaceutical Chemistry Section, the Key Performance Measures Relating to the Statutory Testing of Chinese Medicines and Pharmaceuticals are:

Key Performance Measures Relating to the Statutory Testing of Chinese Medicines and Pharmaceuticals

Targets #

Testing of Chinese Medicines and Pharmaceuticals Targets 2017
(Actual)
2018
(Actual)
2019
(Plan)
Urgent samples relating to Chinese medicine incidents within two working days (%) 95 100 100 95
Other Chinese medicine samples within reporting time averaging 30 working days (%) 95 99 99 95
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 Chinese Medicines and Pharmaceuticals

Tests Performed on Chinese Medicines and Pharmaceuticals 2017
(Actual)
2018
(Actual)
2019
(Estimate)
Urgent samples relating to Chinese medicine incidents 584 276 N.A.§
Other Chinese medicine samples 83,828 81,084 80,000
Urgent samples relating to pharmaceutical incidents 725 292 N.A.§
Other pharmaceutical samples 54,598 53,910 51,000

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