WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 885 - Thirty-fifth Report
(1999; 168 pages) [Spanish] View the PDF document
Table of Contents
View the documentWHO Expert Committee on Specifications for Pharmaceutical Preparations
View the document1. Introduction
Open this folder and view contents2. The international pharmacopoeia and related issues
Open this folder and view contents3. International Chemical Reference Substances and Infrared Reference Spectra
Open this folder and view contents4. Quality control - national laboratories
Open this folder and view contents5. Good manufacturing practices
Open this folder and view contents6. Quality systems and inspection
Open this folder and view contents7. Other quality assurance topics
Open this folder and view contents8. Nomenclature and terminology
Open this folder and view contents9. Legal aspects of pharmaceuticals
Open this folder and view contents10. Regulatory issues
Open this folder and view contents11. Training activities
View the document12. Pharmaceuticals contaminated with diethylene glycol
View the documentAcknowledgements
View the documentReferences
View the documentAnnex 1. List of available International Chemical Reference Substances1
View the documentAnnex 2. List of available International Infrared Reference Spectra1
Open this folder and view contentsAnnex 3. General guidelines for the establishment, maintenance and distribution of chemical reference substances
Open this folder and view contentsAnnex 4. Good manufacturing practices: authorized person - role, functions and training
Open this folder and view contentsAnnex 5. Good manufacturing practices: supplementary guidelines for the manufacture of pharmaceutical excipients
Open this folder and view contentsAnnex 6. Guidelines for inspection of drug distribution channels
View the documentAnnex 7. Good pharmacy practice in community and hospital pharmacy settings
Open this folder and view contentsAnnex 8. National drug regulatory legislation: guiding principles for small drug regulatory authorities
Close this folderAnnex 9. Provisional guidelines for developing training programmes: inspection and examination of counterfeit pharmaceuticals
Open this folder and view contents1. General remarks
Open this folder and view contents2. Training programme for inspection
Close this folder3. Training programme on examination
View the document3.1 Course objectives
View the document3.2 Types of training
View the document3.3 Educational background of trainees and trainers
View the document3.4 Course programme items
View the document3.5 Duration of course
View the document3.6 Reiterative training
View the document3.7 Assessment
View the document3.8 Certificate
View the document3.9 Evaluation of the programme
View the documentReferences
View the documentWorld Health Assembly resolutions
View the documentAppendix 1 The practical issues of organizing and implementing the programme
View the documentAppendix 2 Thin-layer chromatography and its application
View the documentWorld Health Organization Technical Report Series
View the documentSelected WHO Publications of Related Interest
View the documentBack Cover
 

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.

 

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