GL 8 R Stability testing for medicated premixes

GL 8 (R) – Stability testing for medicated premixes

Disclaimer > These slides have been provided for training purposes only. The presenter has made every attempt to ensure that they are consistent with relevant VICH guideline(s). > As always, the original Guideline(s) should be used as the primary source of information for working with regulators. 2

1. Scope and objective 2. Storage test conditions and test parameters 3

1. Scope and objective 4

1. Scope and objective Ø VICH GL 8 is an annex to VICH GL 3 - Stability testing of new veterinary drug substances and medicinal products. Ø Objective is to recommend acceptable stability information for medicated premix drug products containing new molecular entities, in line with VICH GL 3. Ø 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 Ø 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) Ø 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 GL 3 • 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 8

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