(1997; 248 pages) [French]
3.2 Drug regulatory authorities
Drug regulatory authorities must request adequate stability data from manufacturers in support of their claims concerning the shelf-life of registered products relevant to their countries. These data must be evaluated in the light of scientific knowledge and experience.
They should develop means to ensure that relevant information on shelf-life and storage conditions is readily available to all concerned, for example by establishing regulations on labelling. They should ensure, when inspections of manufacturing establishments are carried out in accordance with the requirements of Good Practices in the Manufacture and Quality Control of Drugs (4), that appropriate stability-testing programmes for marketed products are being followed.
Guidelines and inspections are necessary to ensure that drug products are adequately handled and stored in the pharmaceutical supply system - for example, by requiring that the temperature regimen recommended by the manufacturer is followed, that there is appropriate control of other environmental factors, that a proper system of stock rotation (“first-in-first-out” rule) is maintained, and that expired products are destroyed. More detailed consideration of such factors is to be found in publications by FIP and IFPMA (7) and others (8, 9). The importance of adequate storage facilities cannot be overemphasized. Experience in many countries proves that investment in warehouses is cost-effective. Products should be monitored by random visual inspection and where possible by laboratory testing at various stages in the distribution system (including hospital wards).