(1999; 168 pages) [Spanish]
A comprehensive system to assure the safety, efficacy and quality of pharmaceutical products at a national level has the following elements:
• Legal: drug legislation
- 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
- standards and norms
- 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.