(1997; 248 pages) [French]
4. Drug quality surveillance during marketing
Quality surveillance during marketing is an integral function of a drug control agency. It is undertaken by monitoring and auditing procedures involving both inspection and laboratory testing.
The places in which drugs are manufactured, stored and distributed should be known to the control authorities. This information can be obtained by requiring all manufacturers, importers and distributors to give the control authorities official notification of their planned activities before they commence operations, and to comply with any particular regulations.
Drug quality surveillance is facilitated if lists of nonproprietary names are established for all pharmaceutical substances on the market in a country, with references to trade names where applicable.
To aid the application of procedures for the recall of pharmaceutical products, it might be useful if the control authorities had knowledge of the persons responsible for marketing in each manufacturing enterprise, as well as information about the distribution mechanism and the destination of the products.