Historical
EP25-A Vol. 29 No. 20
Diagnostic Reagents; Approved Guideline Stability of In Vitro Diagnostic Reagents; Approved Guideline
This guidance document provides information on the establishment and verification of shelf-life and in-use stability claims for quantitative and qualitative in vitro diagnostic (IVD) reagents. It includes background information and typical content to consider when creating a stability testing plan for a particular product, logistics of performing the studies, recommended data analyses, and documentation of stability claims. Additional topics include assessment of product transport conditions on stability claims, stability monitoring (verification), and uses of accelerated stability testing. The intended users of this guideline are primarily manufacturers of IVD reagents and regulatory agencies. (Replaces EP25-P Vol. 28 No. 32)
Content Provider
Clinical And Laboratory Standards Institute [clsi]
