1. GL8 (R) – Stability testing for medicated premixes

2. Scope and objective
Storage test conditions and test parameters

3. 1. Scope and objective

4. 1. Scope and objective
VICH GL 8 is an annex to VICH GL3 - Stability testing of new veterinary drug substances and medicinal products.
Objective is to recommend acceptable stability information for medicated premix drug products containing new molecular entities, in line with VICH GL3.
Definition: A Medicated Premix is a veterinary medicinal product consisting of a mixture of one or more drug substances, generally with a carrier, that is prepared to facilitate oral administration of the drug to animals when mixed with feed.

5. 2. Storage test conditions and test parameters

6. 2. Storage Test conditions and Test parameters
Medicated premixes are recommended to be tested at 25°C +/- 2°C/ 60% RH +/- 5% (long-term testing) and 40°C +/- 2°C / 75% RH +/- 5% (accelerated testing)
If significant change (= failure to meet specifications) is observed at the accelerated condition, additional testing at 30°C +/6 2°C/ 60 % RH +/6 5% should be performed

7. 2. Storage Test conditions and Test parameters
Same schedule intervals as described in VICH GL3
For long-term studies and products with a proposed shelf life of at least 12 months, the frequency of testing should normally be every 3 months over the first year, every 6 months over the second year, and annually thereafter through the proposed shelf life.
At the accelerated storage condition, a minimum of three time points, including the initial and final time points (e.g. 0, 3, and 6 months), from a 6-month study is recommended.
Shelf-life specifications should include stability indicating test parameters
i.e. those attributes of the medicinal product that are susceptible to change during storage and are likely to influence quality, safety, and/or efficacy. The testing should cover, as appropriate, the physical, chemical, biological, and microbiological attributes, preservative content (e.g. antioxidant, antimicrobial preservative), and functionality tests (e.g. for a dose delivery system). Analytical procedures should be fully validated and stability indicating).
Testing should be performed in the final packaging proposed for marketing