Government Laboratory - Pharmaceutical Chemistry Section

Government Laboratory

Analytical and Advisory Services Division

Pharmaceutical Chemistry Section

About the Section

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 Import and Export Ordinance
The Pharmacy and Poisons Ordinance
The Antibiotics Ordinance
The Water Pollution Control Ordinance, and
The Public Health (Animals and Birds) Ordinance
The Trade Descriptions Ordinanace

In addition, the Section inspects pharmaceutical products, which are prepared by the Pharmaceutical Manufactory of the Department of Health or purchased by the Government Logistics Department and the Hospital Authority, to check on the compliance with specifications.

Key Personnel

Senior Chemist: Dr. Clare Ho (Tel No.: 3104-3460 E-mail : cho@govtlab.gov.hk)

Chemist (E-mail address)	Tel. No.
Dr. K C Chan, Chemist (kcchan@govtlab.gov.hk)	3104-3463
Ms. P K Chan, Chemist (pkchan@govtlab.gov.hk)	3104-3464
Mr. C T Hung, Chemist (cthung@govtlab.gov.hk)	3104-3461
Dr. H K Lam, Chemist (hklam@govtlab.gov.hk)	3104-3052
Dr. Edward S H Lau, Chemist (eshlau@govtlab.gov.hk)	3104-3464
Dr. Timothy Wong, Chemist (twong@govtlab.gov.hk)	3104-3051
Dr. Michael H P Yau, Chemist (hpyau@govtlab.gov.hk)	3104-3462

Quality Assurance

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

Key Instruments

The following instruments are used routinely by the Section:

Matrix-Assisted Laser Desorption Ionization Time-of-Flight Mass Spectrometer System
Gas Chromatographs with Mass Selective Detector and Flame Ionization Detector
High Performance Liquid Chromatographs with Evaporative Light Scattering Detector, Differential Refractometer Detector, Mass Selective Detector, Photodiode Array Detector and Scanning Fluorescence Detector
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	2006 (Actual)	2007 (Actual)	2008 (Plan)
Pharmaceuticals (quality control) within target reporting time averaging 14 working days (%)	95@	99	98	95
Pharmaceuticals (registration) within target reporting time averaging 30 working days (%)	90	93	91	90

*	Different samples require different analytical procedures, thus different target reporting time applies. The quoted number of working days required represents an average of target reporting time for the different samples within the category.
@	The target has been revised from 92% to 95% with effect from 2007.

Key Indicators

Key Indicators for Statutory Testing of Pharmaceuticals

Tests Performed on Pharmaceuticals	2006 (Actual)	2007 (Actual)	2008 (Estimate)
Pharmaceuticals (quality control)	21,878	20,750	23,000
Pharmaceuticals (registration)	19,748	20,139	19,000

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