Pharmaceutical Quality and Investigation Section
About the Section
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.
Pharmaceutical Items
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.
Quality Assurance
About 10% of the tests conducted in the Section are for QC purposes.
Key Instruments
The following instruments are used routinely by the Section:
- High Performance Liquid Chromatograph — Tandem Mass Spectrometer
- High Performance Liquid Chromatograph — Quadrupole Time of Flight Mass Spectrometer
HPLC-QTOF
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 #
# 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
‡ 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 the occurrence of the type of incidents or the number of tests required.