Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products: Guidance for Industry
Information
Type
Guidance
Regulated products
Animal & Veterinary, Biologics, Drugs, Medical Devices
Topics
Administrative / Procedural, Postmarket
Published
February 25, 2008
Last updated
May 6, 2020
Description
This document provides guidance on using container and closure system integrity testing instead of sterility testing for stability protocols of sterile products.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)