By Not provided
Published in: CHPA bulletin
Published on: March 11, 2024
The purpose of stability testing is to provide evidence on how the quality of a drug product varies with time under the influence of a variety of environmental factors, such as temperature, humidity, and light, shelf life for the drug product and recommended storage conditions. In cases where in-use testing is required then this best practice provides examples of how to conduct the testing. The purpose of an in-use stability study is to establish the period of time during which multi-dose products can be safely and effectively used after opening and still comply with critical quality attributes (shelf-life specifications). In-use stability is generally applicable to aqueous preparations; however, some regulatory agencies are now requesting in-use stability data for all other dosage forms, e.g., topical creams/ointments, solid dose tablets/capsules in multi-dose packaging.
