(1997; 248 pages) [French]
As stated in Good Practices in the Manufacture and Quality Control of Drugs (4), it is the responsibility of manufacturers to ensure the quality of the drugs they produce. Similarly, they have the responsibility to develop appropriate dosage forms (including packaging) that are adequately stable under climatic conditions prevailing in the country or countries in which the preparations are intended to be used.
The manufacturer must establish the shelf-life of the product in relation to recommended storage conditions by using an appropriate stability-testing programme. Full details of the work carried out to establish the shelf-life should be made available to drug regulatory authorities. The expiry date and recommended storage conditions must be communicated to all involved in the pharmaceutical supply system and to patients; it is recommended that this information should be given on the label. When necessary, the utilization period must be determined and additionally specified on the label.