About this document
Guidance on Shelf-Life for Dosage Forms by adriana voinea is a document available to read on EtoBox.
The document provides guidance on determining the start date of the shelf life for finished drug products. It states that the expiration date should be calculated from the date of batch release, which should not exceed 30 days from production. For combination products, production date is when ingredients are first combined, and for single ingredient products it is the initial filling date.
- Author
- adriana voinea
- Language
- EN