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).
What this does not cover
stated in the document's own scope- Covers stability study design for new veterinary drug substances and finished products; the companion guidelines cover related cases — new dosage forms (VICH GL4), photostability (GL5), and medicated premixes (GL8).
- Sets stability study design, not the wider GMP for manufacturing the product, which sits in the applicable veterinary GMP framework.
- Addresses veterinary medicines; the equivalent human-medicine guidance is ICH Q1A(R2).
Always verify against the current published text before relying on it for a submission or inspection.
Overview
VICH GL3 is the harmonised stability-testing guideline for veterinary medicines — the veterinary counterpart of ICH Q1A. It sets out how to design stability studies for new veterinary drug substances and finished products so that a re-test period for the substance and a shelf life for the product can be justified with data. It specifies the storage conditions to test (long-term, intermediate, and accelerated), the testing frequency over the study, and the study design — including batch selection and the attributes to monitor — that regulators in the VICH regions expect to see.
Scope & applicability
Stability studies supporting re-test periods and shelf lives for new veterinary drug substances and medicinal products.
Legal basis & how it acquires force
GL3 is a guideline of VICH — the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products. Like an ICH guideline, it is not itself law; it takes effect when each VICH region adopts it into its own veterinary framework. The FDA Center for Veterinary Medicine, the EMA Committee for Veterinary Medicinal Products, and Japan’s authority each implement GL3, so a sponsor meets the regional requirement while GL3 supplies the harmonised technical standard.
Document structure
| Part | Covers |
|---|---|
| Drug substance | Stress testing, storage conditions, and testing frequency for the active substance, supporting a re-test period |
| Drug product | Study design for the finished product, supporting the labelled shelf life |
| Storage conditions | Long-term, intermediate, and accelerated conditions, including conditions for different climatic zones |
| Testing frequency | The schedule of time points across long-term and accelerated studies |
| Evaluation and labelling | How the data justify a re-test period or shelf life and the resulting storage statement |
Quick reference · Stability storage conditions
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.
Key requirements
- 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
Implementation tips
- Leverage your ICH Q1A stability SOPs — GL3 is deliberately parallel
- Confirm the climatic zone(s) for the intended markets before setting conditions
- Keep the stability commitment and post-approval protocol explicit
Revision notes
Adopted by VICH (GL3(R), 2007) harmonising veterinary stability testing across the EU, Japan, and US; aligned with ICH Q1A(R2).
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
GL3 is deliberately harmonised with ICH Q1A(R2), the human-medicine stability guideline, so the study design and storage conditions are broadly the same across human and veterinary products. It works with the other VICH stability guidelines — GL4 on new veterinary dosage forms, GL5 on photostability, and GL8 on medicated premixes — as a family covering veterinary stability testing.
VICH GL3(R): frequently asked questions
Quick answers to common questions about VICH GL3(R).
What is VICH GL3 the veterinary equivalent of?
It is the veterinary counterpart of ICH Q1A(R2), the human-medicine stability-testing guideline. VICH deliberately harmonised GL3 with Q1A so storage conditions and study design broadly match across human and veterinary products.
Which regions apply VICH GL3?
The VICH regions — the United States (FDA CVM), the European Union (EMA CVMP), and Japan — each adopt GL3 into their veterinary frameworks, with other countries participating as observers.
What does a VICH GL3 study establish?
The data justify a re-test period for a drug substance and a shelf life for a finished veterinary product, together with the storage-condition statement that appears on the label.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.