Stability Testing of New Veterinary Drug Substances and Medicinal Products
The VICH stability-testing guideline for veterinary drug substances and products — the veterinary analogue of ICH Q1A. It defines the storage conditions, testing frequency, and study design used to establish re-test periods and shelf lives for veterinary medicines across the VICH regions (EU, Japan, US).
Stability studies supporting re-test periods and shelf lives for new veterinary drug substances and medicinal products.
General-case storage for veterinary drug substances and products (VICH GL3(R), mirroring ICH Q1A(R2)).
| Study | Storage condition | Minimum data at submission |
|---|---|---|
| Long-term | 25 °C ± 2 °C / 60% RH ± 5% (or 30 °C ± 2 °C / 65% RH ± 5%) | 12 months |
| Intermediate | 30 °C ± 2 °C / 65% RH ± 5% | 6 months |
| Accelerated | 40 °C ± 2 °C / 75% RH ± 5% | 6 months |
Intermediate testing applies when a “significant change” occurs under accelerated conditions. Different conditions apply to products in semi-permeable containers or intended for refrigerated or frozen storage.
Source: VICH GL3(R) / ICH Q1A(R2), general case. Verify against the current text before relying on it for a submission.
- 01Run stability under defined long-term, intermediate, and accelerated conditions
- 02Justify any bracketing or matrixing of the study design
- 03Establish re-test periods and shelf lives from the data
- 04Document the stability protocol and results for submission
Adopted by VICH (GL3(R), 2007) harmonising veterinary stability testing across the EU, Japan, and US; aligned with ICH Q1A(R2).
VICH GL3(R): frequently asked questions
Quick answers to common questions about VICH GL3(R).
What is VICH GL3(R)?
VICH GL3(R) — Stability Testing of New Veterinary Drug Substances and Medicinal Products — is a guideline issued by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products. The VICH stability-testing guideline for veterinary drug substances and products — the veterinary analogue of ICH Q1A. It defines the storage conditions, testing frequency, and study design used to establish re-test periods and shelf lives for veterinary medicines across the VICH regions (EU, Japan, US).
Who does VICH GL3(R) apply to?
Stability studies supporting re-test periods and shelf lives for new veterinary drug substances and medicinal products.
What are the key requirements of VICH GL3(R)?
VICH GL3(R) requires, among other things: Run stability under defined long-term, intermediate, and accelerated conditions; Justify any bracketing or matrixing of the study design; Establish re-test periods and shelf lives from the data; Document the stability protocol and results for submission.
When was VICH GL3(R) last updated?
The current version of VICH GL3(R) dates from November 2007. Adopted by VICH (GL3(R), 2007) harmonising veterinary stability testing across the EU, Japan, and US; aligned with ICH Q1A(R2).
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