Technical Guidance Series 2 (TGS–2) for WHO Prequalification – Diagnostic Assessment: Establishing stability of in vitro diagnostic medical devices. WHO Expert Committee on Biological Standardization, Sixty-eighth Report; WHO Technical Report Series No. 1011, 2018, Annex 5
(2018; 61 pages)

Abstract

Stability is the ability of an IVD reagent to maintain its performance characteristics over a defined time interval. The purpose of most stability studies is to establish or verify the time interval, and the storage conditions that can maintain stable IVD performance characteristics.

The stability of an IVD is fundamental to its reliable performance over a defined period of time. It is a regulatory requirement for the manufacturer to provide objective, scientifically sound evidence to support all claims made regarding the stability of an IVD. In addition, a manufacturer can use stability studies to demonstrate the probability that lots manufactured up to the end of the life-cycle of the IVD will meet predetermined user needs (as identified in design inputs).

The purpose of this document is to provide IVD manufacturers with guidance on possible approaches to determine stability. It also describes the expectations of WHO prequalification in relation to stability studies.

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