VICH GL51 Quality: statistical evaluation of stability data - Scientific guideline

This document addresses the evaluation of stability data that should be submitted in registration applications for new molecular entities and associated veterinary medicinal products. It provides recommendations on establishing retest periods and shelf lives for drug substances and veterinary medicinal products intended for storage at or below room temperature. It covers stability studies using single- or multi factor designs and full or reduced designs.

Keywords: Stability, stability testing, stability data, retest period, shelf life, VICH, veterinary medicinal product (VMP)

Current effective version

VICH GL51: Quality: statistical evaluation of stability data

AdoptedReference Number: EMA/CVMP/VICH/858875/2011Summary:

This guideline is intended to provide recommendations on how to use stability data generated in accordance with the principles detailed in the VICH guideline “GL3(R) Stability Testing of New Veterinary Drug Substances and Medicinal Products” (hereafter referred to as the parent guideline) to propose a retest period or shelf life in a registration application.

Document history - Revision 1 (current)

VICH GL51: Quality: statistical evaluation of stability data

AdoptedReference Number: EMA/CVMP/VICH/858875/2011Summary:

This guideline is intended to provide recommendations on how to use stability data generated in accordance with the principles detailed in the VICH guideline “GL3(R) Stability Testing of New Veterinary Drug Substances and Medicinal Products” (hereafter referred to as the parent guideline) to propose a retest period or shelf life in a registration application.

Overview of comments received on VICH guideline on statistical evaluation of stability data (GL 51)

Reference Number: VICH GL-51

Draft VICH GL51: Quality: statistical evaluation of stability data

Draft: consultation closedConsultation dates: 08/12/2011 to 12/06/2012Reference Number: EMA/CVMP/VICH/858875/2011