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
Close this folder6. Laboratory services
Open this folder and view contentsNational laboratories for drug quality surveillance and control1
Close this folderGood laboratory practices in governmental drug control laboratories1
View the document1. General
Open this folder and view contents2. Management and operational issues
View the documentReferences
Open this folder and view contentsSampling procedure for industrially manufactured pharmaceuticals1
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

1. General

A governmental drug control laboratory is a laboratory maintained by the drug regulatory authority for carrying out the tests and assays required to establish that a drug conforms to the quality specifications claimed for it. Some countries maintain larger establishments described as “drug control centres” or “drug control institutes”.

The contribution of a drug control laboratory to a national drug control system was described in the twenty-seventh report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations (1). In most countries the laboratory is responsible for analytical services only, and not for pharmaceutical inspection. However, some aspects of inspection are considered in these guidelines.

A control laboratory can provide effective support for a drug regulatory agency and its inspection services only if the analytical results it provides can be relied upon to describe accurately the properties of the samples it assesses, to permit the correct conclusions to be drawn about the quality of each drug, and to serve as an adequate basis for any subsequent administrative and legal action.

Correct assessment of the quality of a drug sample is dependent on:

- the submission of a representative sample to the laboratory, together with a precise indication of why the test is requested;

- a correctly planned and meticulously executed analysis; and

- a competent evaluation of the results to determine whether the sample complies with the specification.

Precise documentation and efficient routines are required to make each operation as simple and as foolproof as possible.

These guidelines provide advice on the analysis both of dosage forms and of pharmaceutical raw materials; particular consideration is given to developing countries wishing to establish governmental drug control laboratories or having recently done so.

Many of the recommendations are also relevant to drug testing in pharmaceutical production plants, but this is a matter of the repetitive testing of a limited number of pharmaceutical products, whereas governmental control laboratories theoretically have to deal with all drugs on the market and therefore have to use a wider variety of test methods.

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