The shelf life of a drug refers to the period of time during which the product is expected to maintain its specifications and remain safe and effective under the recommended storage conditions. This period is indicated by the manufacturer on the product packaging as the expiration date (German: Verfallsdatum) and is based on scientific stability tests carried out in accordance with legal requirements. The shelf life (German translation: Laufzeit) is determined on the basis of systematic studies that assess how various environmental factors (e.g. temperature, humidity and light) affect the product over time.

Fundamental aspects of the shelf life of drugs:

• Stability studies: Stability studies are carried out under controlled conditions in order to determine how long a drug retains its original properties. These studies include the testing of physical, chemical and microbiological parameters.
• Storage conditions: To maintain drug quality, it is important to comply with the recommended storage conditions (translation into German: Lagerungsbedingungen) indicated on the packaging, e.g. room temperature or protection from light. Improper storage can lead to accelerated deterioration of the drug.
• Expiration date: After this date, the drug should no longer be used, as its safety, efficacy and quality can no longer be guaranteed. The expiration date is normally given in the format month/year or month/day/year.

The determination of the shelf life is of crucial importance when it comes to ensuring drug safety, efficacy and quality. Regulatory authorities monitor the procedures for determining the expiration date very closely and require manufacturers to submit extensive data from stability studies to confirm the specified shelf life.

Our experienced GMP translators and pharmaceutical interpreters will be happy to assist you if you need to have pharmaceutical documents translated or require language support during a GMP inspection by foreign regulatory authorities.