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
Close this folderAnnex 6. Guidelines for inspection of drug distribution channels
View the documentIntroductory note
View the documentGeneral considerations
View the documentGlossary
Open this folder and view contents1. Drug inspectors
Open this folder and view contents2. Inspection of establishments in the drug distribution chain
View the documentReferences
View the documentSelected further reading
View the documentAppendix 1. Checklist for inspection and the preparation of a report
View the documentAppendix 2. Guidance on sampling
View the documentAppendix 3. Guidance for inspection when pharmaceutical products are suspected to be counterfeit, spurious or substandard
View the documentAppendix 4. Sample receipt form
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
Open this folder and view contentsAnnex 9. Provisional guidelines for developing training programmes: inspection and examination of counterfeit pharmaceuticals
View the documentWorld Health Organization Technical Report Series
View the documentSelected WHO Publications of Related Interest
View the documentBack Cover

General considerations

A comprehensive system to assure the safety, efficacy and quality of pharmaceutical products at a national level has the following elements:

• Legal: drug legislation


• Administrative:


- drug regulatory authority with functions of product registration, licensing of manufacturers, importers and distributors (wholesale, retail and for institutional supply), inspection and independent testing of samples


- enforcement


• Technical:


- regulations


- standards and norms

- guidelines

- independent quality control laboratory(ies)


This document focuses on one element-inspection-and in particular on inspection in the pharmaceutical supply system.

The usefulness of drugs in the treatment of ailments, diseases and disorders is well recognized and appreciated. It is also recognized that the inappropriate use of drugs can produce severe toxic effects, some of which may be fatal. National drug laws have therefore been introduced to reduce risks associated with the use, misuse and abuse of pharmaceutical preparations.

Drugs differ in the severity of their side-effects and toxicity and these differences are taken into consideration in the classification of drugs in national drug laws. Drugs may be classified into four types as follows: over-the-counter drugs, pharmacy-only drugs, prescription-only drugs and prohibited drugs.

The distribution, supply, import, export, sale, storage, advertisement and dispensing of drugs are normally regulated by national drug laws, which provide for a system of licences to be issued by a drug regulatory authority for such drug-related activities. The drug laws may identify a ministry/department/agency that would function as the drug regulatory authority as well as provide for the enforcement of the drug laws, using a system of inspections organized through an inspectorate(s).

The inspectorate advises on whether applicants and premises should be issued licences to engage in drug-related activities. The inspectorate ensures that counterfeit, spurious and substandard pharmaceutical products are not found in the national pharmaceutical supply system or outside it, and that licensed premises and authorized persons adhere to existing laws and regulations. To do this, the inspectorate gathers information on the working of the drug laws by liaising with other law enforcement agencies and health institutions, including health-care professional associations.

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