Quality Assurance of Pharmaceuticals - A Compendium of Guidelines and Related Materials - Volume 1
(1997; 248 pages) [French] View the PDF document
Table of Contents
Open this folder and view contentsIntroduction
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
Close this folder9. Training
View the documentTraining programme in drug analysis1,2
View the documentPlaces of training in drug quality control offered by the International Federation of Pharmaceutical Manufacturers Associations1
View the documentSelected WHO publications of related interest
View the documentBack cover
 

Places of training in drug quality control offered by the International Federation of Pharmaceutical Manufacturers Associations1

1 Adapted from WHO document PHARM/82.3/Rev. 1.

At the Thirty-second World Health Assembly in May 1979 the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) made an offer of training fellowships in drug quality control in the pharmaceutical industry. Places are available for nationals of developing countries who are employed by governmental drug control laboratories (not connected with the manufacture of pharmaceuticals) or pharmaceutical inspection services. The training is carried out in the analytical laboratories or quality control departments of pharmaceutical companies and covers one of three areas:

(a) chemical control
(b) microbiological control
(c) biological control

According to individual circumstances, the training may last three to six months. There is a possibility of more limited training for persons from countries interested only in dosage forms of pharmaceuticals, and combined training in all three areas can be arranged where a demand exists. The companies that provide the training operate in a wide geographical area so in many cases training can take place at convenient locations. Candidates for these training fellowships will often be those who work in conditions with limited capital and technical resources - such as for automated equipment - and every effort will be made to tailor the training to individuals needs. The application for training should include as much detail as possible about the facilities and equipment available in the applicant’s control laboratory.

The application procedure is as follows: the government proposing a candidate submits a Fellowship Application Form through the WHO Programme Coordinator to the WHO Regional Office, which examines the application, ensures that funds are available, and transmits the proposal to WHO headquarters. No preference should be expressed in the application regarding the identify of the sponsoring company. IFPMA is then requested to identify a suitable training place, after which WHO headquarters transmits the relevant information to the Regional Office for further action.

The IFPMA officer does not cover the travel costs of trainees. These costs have to be financed from WHO Regional Office budgets or from funds allocated by the government concerned. The company with which the candidate is placed will cover all the costs of training and provide an allowance to cover accommodation and living expenses.

IFPMA training in quality control of pharmaceuticals: for nationals of developing countries currently employed by government agencies or academia

Details of the three training areas are given below; in addition managerial topics may be covered, according to the candidate’s background and requirements. Examples include: laboratory management and related GMP (good manufacturing practices) requirements; documentation and record keeping; statistical validation of sampling and testing procedures; cost considerations and cost-effectiveness of analytical procedures; method development and validation; environmental and safety aspects of laboratory management.

Chemical control

This covers physico-chemical methods for routine testing of drug substances, excipients, dosage forms and packaging materials. Examples of subjects which might be included in a training programme are:

- Identity tests - for example, chemical, chromatographic and spectrophotometric

- Physical tests, e.g. uniformity of weight, hardness, disintegration, melting points

- Impurity tests, e.g. thin-layer chromatography, gas-liquid chromatography, spectrophotometric

- Dissolution testing

- Assay methods, chemical and instrumental, for batch control and stability monitoring

- Instrumentation: checking and calibration

- Evaluation of test results

Professional qualifications required

Completed education in pharmacy or chemistry with at least basic experience in pharmaceutical analysis; or equivalent knowledge acquired through a long period of practical experience.

Microbiological control

This covers quality control procedures designed to detect microbial contamination in products and in the environment as well as assay methods which use microorganisms for analytical purposes. Examples of subjects which might be included in a training programme are:

- Sterility testing and aseptic techniques

- Determination and classification of bioburden, microscopy

- Microbiological assay methods, e.g. for antibiotics and vitamins

- Challenge tests for effectiveness of preservatives

- Evaluation of results, including statistics

- Microbiological monitoring of production areas and GMP aspects

Professional qualifications required

Completed education in microbiology, pharmacy, medicine or biology with at least a basic theoretical, and if possible practical, knowledge of microbiological testing of drugs; or equivalent knowledge acquired through a long period of practical experience.

Biological control

This covers quality control procedures using animals, cell or tissue cultures, or other biological materials. Examples of subjects which might be included in a training programme are:

- Pyrogen testing
- Testing for abnormal toxicity
- Bioassays of hormones, e.g. insulin, oxytocin
- Evaluation of results, including statistics
- Care and handling of laboratory animals

Professional qualifications required

Completed education in pharmacy, medicine or biology, with at least basic theoretical knowledge of pharmacology, preferably with basic practical experience in pharmacology or in biological testing of drugs; or equivalent knowledge acquired through a long period of practical experience.

Note

Training posts are normally for a period of three to six months, though the length of time will depend on the trainee’s experience, motivation, learning capacity and fluency in the language concerned.

Applicants should have detailed knowledge of which facilities and equipment are available in their own country so as to avoid receiving training that would be of no practical use. In particular, trainees should be familiar with:

- the local availability of instrument servicing and maintenance (which instruments companies have local service teams)

- the local supply of spare parts and other materials necessary to run the equipment.

This does not exclude the possibility of training in new techniques that may become feasible.

 

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