The stability of finished pharmaceutical products depends, on the one hand, on environmental factors such as ambient temperature, humidity and light, and, on the other, on product-related factors, e.g. the chemical and physical properties of the active substance and of pharmaceutical excipients, the dosage form and its composition, the manufacturing process, the nature of the container-closure system and the properties of the packaging materials.
For established drug substances in conventional dosage forms, literature data on the decomposition process and degradability of the active substance (1) are generally available together with adequate analytical methods. Thus, the stability studies may be restricted to the dosage forms.
Since the actual stability of a dosage form will depend to a large extent on the formulation and packaging-closure system selected by the manufacturer, stability considerations, e.g. selection of excipients, determination of their level and process development, should be given high priority in the developmental stage of the product. The possible interaction of the drug product with the packaging material in which it will be delivered, transported and stored throughout its shelf-life must also be investigated.
The shelf-life should be established with due regard to the climatic zone(s) (see section 2) in which the product is to be marketed. For certain preparations, the shelf-life can be guaranteed only if specific storage instructions are complied with.
The storage conditions recommended by manufacturers on the basis of stability studies should guarantee the maintenance of quality, safety, and efficacy throughout the shelf-life of a product. The effect on products of the extremely adverse climatic conditions existing in certain countries to which they may be exported calls for special consideration (see section 6).
To ensure both patient safety and the rational management of drug supplies, it is important that the expiry date and, when necessary, the storage conditions are indicated on the label.