The number of staff working in these laboratories varies greatly, ranging from as few as four full-time posts (actually two full-time and four part-time staff) in the “mini-lab” in Uganda, to as many as 131.5 full-time posts (actually 129 full-time and five part-time staff) working for the Therapeutic Goods Administration Laboratory (TGAL) in Australia.
Given this difference in personnel numbers, the question arises whether all the QC laboratories have adequate staff to perform the task of drug regulation. If the current number of tests performed by the drug regulatory authorities is taken as the numerator, and the number of staff as the denominator, the workload per person can be calculated, as shown in Table 10.3. These results should be considered as preliminary figures which show the number of drug products submitted per staff member, but do not describe the overall workload. The data used to compute these figures do not take into account the work arrangements of staff, nor the number of tests performed per drug, which may vary according to the type of drug and the purpose of the test, as well as other functions which QC staff perform, such as training, research, inspection of industry QC laboratories, etc.
According to this set of data, the workload in terms of the number of products submitted per person is highest in Cyprus, where the size of the staff team is quite small, followed by Estonia. The lowest workload is in Australia and the Netherlands. The relatively low workload of the Australian TGAL staff is attributable to the large number of personnel, while in the Netherlands the low workload is accounted for by the small number of samples. In Venezuela, the number of samples submitted is eight times that in Australia, which has twice the number of staff. Figure 10.1 shows the workload of QC personnel in the 10 countries.
These figures indicate the current workloads in the countries. However, they do not indicate whether the need to monitor drug quality is being met in each country.
Figure 10.1 Workload of QC personnel - average number of samples submitted over four years, 1994-97
The researchers in Cyprus and Malaysia identified a shortage of personnel for QC. Laboratory staff in Cyprus, in particular, have to allocate time both to regulatory control and to analysing Government-manufactured products. Since priority is often given to conducting analyses for the Medical Stores, delays in carrying out QC for regulatory purposes are common. The TGAL in Australia, on the other hand, has fewer pressures related to staffing problems, compared with other areas of the TGA.