(1999; 168 pages) [Spanish]
The quality assurance of drugs at the level of the manufacturer is outlined in the guidelines on good manufacturing practices for pharmaceutical products (GMP) published by WHO (1). Compliance with these guidelines will ensure that products released for distribution are of the appropriate quality. However, if this is to be realized in practice, it is essential that an established drug regulatory authority exists in a Member State, which complies at least with the "Guiding principles for small national drug regulatory authorities" (2).
In addition, the holder of a marketing authorization for a pharmaceutical product, or alternatively the (legal) person responsible for the initial marketing of a product, who ideally should be a pharmacist or a pharmaceutical company authorized to practise in the Member State, should ensure that the product is only released for distribution after it has been established that it conforms with the product specification lodged with the drug regulatory authority.
This level of quality should be maintained throughout the pharmaceutical supply system or distribution network. Basic principles of GMP are applicable to wholesale operations and (to some extent) to retail outlets. These principles may be summarized as follows:
- only authorized products are distributed;
- a quality system is in place which includes quality policy, quality management, appropriate analytical controls, self-inspection;
- personnel are quality-conscious, adequately trained and motivated;
- premises and equipment are suitable for their intended use, and kept in a good sanitary condition;
- all products are received, stored and handled appropriately (protected against contamination, cross-contamination, mix-ups, environmental factors such as heat, severe cold, moisture, light);
- all drug-related operations are performed in accordance with written procedures, are properly supervised and adequately documented; documentation ensures complete traceability of receipt of all materials, quality testing processes (if any) and shipping;
- adequate provisions exist to handle complaints, recalls, and returned goods.
At the same time, many provisions of the GMP guidelines published by WHO are clearly not addressed to wholesalers and retail pharmacies where specific rules and requirements apply. These rules are determined partly by pharmaceutical science and common sense, and partly by national (regional) regulations and standards. In this context reference is made particularly to the guidelines entitled "Good pharmacy practice in community and hospital pharmacy settings" (3). It follows then that the "Provisional guidelines on the inspection of pharmaceutical manufacturers" (4), which are directed to government GMP inspectors, are not adequate to cover inspection in the distribution system. The present document addresses this specific issue.
These guidelines are intended for use by pharmaceutical inspectors in national drug regulatory authorities. They are therefore presented in a format that will allow for easy reference in the field. They should, however, be adapted by national drug regulatory authorities to suit their national legal requirements and available resources.
This document discusses the "simplified" situation when there is a single authority, the drug regulatory authority, where all kinds of drug inspections are located, ranging from those of drug manufacture to the inspections of pharmacies. In reality, these tasks, requiring different inspection skills are usually distributed among different (national and local) authorities.