7.2.1 Qualifications and training
In each of the countries, inspectors of both manufacturing plants and distribution channels are professionals, mostly pharmacists. Some countries also employ pharmacy assistants as inspectors. Uganda, in particular, has a large number of assistant drug inspectors stationed in the regions.
In terms of qualifications, Australia appears to have the most demanding recruitment requirements for GMP inspectors. The TGA’s GMP auditors need to have worked in industry before their appointment and undergo 6-12 months’ formal training after appointment. Similarly, GMP inspectors in the Netherlands must have acquired experience in the pharmaceutical industry.
GMP inspectors generally receive greater formal training than distribution-channel inspectors. In Cyprus, Malaysia and Venezuela, for instance, specialized training courses (or even training abroad) plus on-the-job training are offered to GMP inspectors, while distribution-channel inspectors receive on-the-job training only. Conversely, the MCAZ has provided a formal training course for distribution-channel inspectors, as well as for inspectors of other countries in the region. In Tunisia, inspectors are reported to lack training.
7.2.2 Salary levels
In most of the countries studied, the salaries of GMP and distribution-channel inspectors are lower than those of the professionals working in the facilities which they inspect. In Figures 7.1 and 7.2, the average monthly salaries of GMP inspectors and distribution-channel inspectors are shown, together with those of their counterparts in the private sector.
Figure 7.1 Salaries of GMP inspectors compared with their private-sector counterparts, 1998
* Private sector does not exist in Cuba
Note: Product release person: person responsible for the release of batches of finished products in a manufacturing plant
Figure 7.2 Salaries of distribution-channel inspectors compared with their private-sector counterparts, 1998
* Private sector does not exist in Cuba and data for inspector of distribution channels not available.
** Data for Australia and the Netherlands not complete.
The difference between the monthly salary of a GMP inspector and of a head of production in a private pharmaceutical plant is considerable. The salary of a head of production is 3.3 times greater than that of a GMP inspector in Tunisia, and double that of a GMP inspector in Uganda. In these two countries, the gap between the monthly salary of a distribution-channel inspector and that of a pharmacist working in a retail pharmacy is smaller, but still significant. In Australia and the Netherlands, salaries for pharmaceutical professionals in the public and private sectors are comparable. Only in Cyprus are GMP and distribution-channel inspectors better paid than their private-sector counterparts.
7.2.3 Human resources management
Human resources management systems for inspection differ among countries. In Australia, the same group of personnel is responsible both for licensing of manufacturers and for GMP inspection. In Cyprus, Tunisia, Venezuela and Zimbabwe, GMP inspectors also carry out other drug regulatory functions. One of the results of such an arrangement is that the different functions must compete for the employees’ time. Cuba, Estonia and Tunisia employ both full-time and part-time inspectors for both functions. Other countries have full-time employees only.
Ideally, in order to understand how many staff are required to perform a particular function satisfactorily, human resources should be compared with workload figures. However, comparing the workload of personnel for inspection and other regulatory functions across countries is not straightforward. This is because the actual tasks may not be exactly the same for each function. Furthermore, in many countries the same personnel carry out more than one function. For example, in Australia, GMP inspectors undertake both licensing and GMP audit. They also conduct a training programme for domestic and foreign inspectors. Accurately estimating the number of full-time employees required specifically for the inspection function is therefore difficult.
An attempt is made in Figure 7.3 to give a crude picture of the human resources required in the various countries. For Australia, however, estimating the workload is not possible, owing to a lack of data about the number of distribution-channel inspectors.
Of the 10 countries, Australia has the highest number of staff (18 inspectors) for GMP inspection. Malaysia and the Netherlands come next, with six inspectors each. The inspectors in these three countries are also responsible for the largest numbers of manufacturing firms. In terms of human resources for distribution-channel inspection, Malaysia has the largest number (52), followed closely by Uganda (45). But the number of distribution channels per inspector differs greatly: the figure for Malaysia is five times that for Uganda. The country with the highest number of distribution channels per inspector is the Netherlands, with more than 500 distribution channels to be taken care of by, on average, one inspector, followed by Venezuela (417), Cuba (330) and Cyprus (205).
Figure 7.3 Workload of GMP and distribution-channel inspectors, 1998*
* Distribution channels - includes all types of drug outlet.
** For Australia, no data are available about the number of distribution-channel inspectors.