Quality Assurance of Pharmaceuticals - A Compendium of Guidelines and Related Materials - Volume 1
(1997; 248 pages) [French] View the PDF document
Table of Contents
Close this folderIntroduction
View the documentNational drug regulation
View the documentProduct assessment and registration
View the documentGood manufacturing practices and inspection
View the documentDistribution
View the documentThe international pharmacopoeia and related activities
View the documentBasic tests
View the documentLaboratory services
View the documentInternational trade in pharmaceuticals
View the documentCounterfeit products
View the documentTraining
View the documentConclusion
Open this folder and view contents1. National drug regulation
Open this folder and view contents2. Product assessment and registration
Open this folder and view contents3. Distribution
Open this folder and view contents4. The international pharmacopoeia and related activities
Open this folder and view contents5. Basic tests
Open this folder and view contents6. Laboratory services
Open this folder and view contents7. International trade in pharmaceuticals
Open this folder and view contents8. Counterfeit products
Open this folder and view contents9. Training
View the documentSelected WHO publications of related interest
View the documentBack cover


The establishment and development of pharmaceutical manufacturing facilities and national quality control laboratories in developing countries call for relevant training programmes for technical personnel. In particular, there is an evident need for group training of recent science and pharmacy graduates and for on-site individual training at more advanced level. The following advice on group training is taken from the twenty-ninth report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations:

Ideally, all graduate personnel should undergo a six-month period of preparatory training in practical and theoretical aspects of drug analysis. Emphasis should be on the practical approach, although some provisions should be made for discussion of the theoretical basis of the work, and the experimental programme should be developed having regard to:

- the structure and organization of the model laboratories [described in Chapter 6];

- common practical problems encountered in the analysis of pharmaceutical products;

- the importance of selecting and validating appropriate analytical methods and of evaluating all results.

Following an introductory course lasting about 1 week, in which the general principles of drug quality control and analysis are presented, including an appreciation of their relevance to procurement and distribution, separate courses should be offered in chemical, microbiological, and biological control. It is important, however, that a trainee in one of these disciplines should have a general appreciation of the other aspects of control. A clear perception must be gained of all the duties and responsibilities of an analyst and of the need to institute good laboratory practice in the interests of both efficiency and safety.

Basic training in microbiological control should lay particular emphasis upon sterility testing, microbiological spoilage testing, and potency tests for antibiotics. Guidance is also required on the preparation and monitoring of culture media from locally available materials.

An introduction to biological control should be directed to pyrogen testing and other specific safety tests. Since the testing of biological products, including vaccines, blood products, and hormones, is usually undertaken in specialized institutions, this work falls outside the scope of a general introductory course.

A detailed model syllabus for such training programmes, which could be organized in many national quality control laboratories, is contained in Chapter 9. It covers both the practical and the theoretical aspects of drug analysis for regulatory purposes.

A primary objective is to teach students how to work efficiently and how to determine priorities for analyses so that limited resources can be used to best effect. This need is obviously most acute where facilities are most limited.

The syllabus provides for a general introduction to the objectives and principles of drug control and laboratory management, followed by separate parallel courses in chemical, microbiological and biological techniques of analysis. A six-month course is proposed for both chemical and microbiological analysis, and a course of three to four months for biological (pharmacological) techniques.

The sequence in which the subjects are listed is that in which the various analytical techniques are used in the control of specific categories of pharmaceutical raw materials and dosage forms, and it differs in this respect from the usual presentation of analytical methods.

Obviously trainees working in a first-stage laboratory, such as that described in Chapter 6, will not need practical experience in all the methods of analysis covered by the syllabus. If the training is to be used to best advantage, it is therefore important for the course organizer to obtain advance information on the facilities available to participants in their own countries.

A simpler syllabus should also be drawn up for the training of laboratory technicians and courses should be organized for laboratory managers.

On-site training of persons already employed in national quality control laboratories is available through the scheme operated under the aegis of the International Federation of Pharmaceutical Manufacturers Associations, as described in Chapter 9.

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