Shelf Life Assessment of Drug Product after opening Container for the first time

ABSTRACT: The continued integrity of products in multi-dose containers after the first opening is an important quality issue. The purpose of in-use stability testing is to establish a period of time during which the product in multi-dose container can be used retaining quality within an accepted specification once the container is opened. KEYWORDS: Multi-dose, container, quality in-use, stability, testing

Batch Selection • Best Practices • Best Practices • Parameters • Planning • Protocols • Resources • Sample Control • Storage • Study Design • Study Types