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
Close this folder2. Training programme for inspection
View the document2.1 Course objectives
View the document2.2 Types of training
View the document2.3 Educational background of trainees and trainers
View the document2.4 Course programme items
View the document2.5 Duration of training course
View the document2.6 Reiterative training
View the document2.7 Assessment
View the document2.8 Certificate
View the document2.9 Evaluation of the programme
Open this folder and view contents3. Training programme on examination
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

2.4 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.;

- factors leading to the manufacture and sale of counterfeit pharmaceuticals (e.g. profit);

- measures to detect counterfeiting (e.g. checking records of distributors and measurement of various physical properties of the product, labelling features, packaging materials and packaging of various drug forms);

- methods of market surveillance for detection of counterfeit pharmaceuticals at the import, manufacture, distribution and sales levels, based on intelligence services and visual examination of samples;

- organizing sample collection;

- sample and test report handling;

- preparation for prosecution by:


(a) investigation of cases to identify the suspect persons responsible for the offence;
(b) collection of legal evidence for proceedings in the courts;
(c) maintaining a system of security of evidence including persons and case property;


- prosecution of offenders;


- proper follow-up of the cases;

- development of a network of informants;

- education about the system to ensure distribution and sale only of legitimate products in the market, e.g. system of warranty;

- familiarization with the methods of information sharing, coordination and collaboration with all concerned in combating counterfeiting, including other inspectors, health professionals, and representatives of the pharmaceutical industry, police and other investigating agencies at the national, and where necessary, at the international level;

- relations between the pharmaceutical inspectorate and other law enforcement agencies, such as customs, police, health inspectorate, veterinary inspectorate, legal departments;

- relations with drug manufacturers at home and abroad;

- relations with WHO, including reporting to and being informed by WHO, through the national drug regulatory authorities;

- reference data in books or electronic form (e.g. Internet);

- security aspects;

- record-keeping, the importance of properly documented standard operating procedures, including description of samples according to a defined model;

- preparation of official reports.


Course programme items may vary according to the specific requirements of each country. Further guidance may be found in the "Guidelines for inspection of drug distribution channels" (3).

to previous section
to next section
The WHO Essential Medicines and Health Products Information Portal was designed and is maintained by Human Info NGO. Last updated: December 6, 2017