(1999; 168 pages) [Spanish]
3.4 Course programme items
The following items should be included in the course; the actual content of each item will depend on the prior experience of the trainees:
- overview of relevant legislation;
- national drug regulatory systems, inspection and quality control;
- drug distribution systems;
- illegal distribution channels;
- types of counterfeit pharmaceuticals encountered;
- general characteristics of various dosage forms, such as active ingredient to excipient ratio in tablets, capsules, ampoules, powder for injection, ointments, creams, etc.;
- sampling methods;
- reference substances and working standards: importance and maintenance;
- reference data in books or electronic form (e.g. Internet);
- security aspects;
- record-keeping, the importance of properly documented laboratory work including description of samples;
- preparation of official reports;
- relations with WHO.
After demonstration of the techniques to be used, trainees should practise with an adequate number of known dosage forms, preferably including capsules, tablets, injectable preparations and ointments. Trainees will then test unknown samples, report on their work and draw conclusions as to whether the samples are counterfeit or require additional analysis. The results will be compared with previously determined data and will be discussed in the group.
In the course, the trainee will be taught to perform various examinations including:
- examination of labelling features, packaging materials and packaging of various drug forms;
- measurement of various physical properties of the product;
- thin-layer chromatography (see Appendix 2);
- other specifically selected examination procedures.