EMA: In-Use Stability Testing of Veterinary Medicinal Products
The EMA published the new guideline on in-use stability testing of veterinary medicinal products. This guideline applies to veterinary medicinal products supplied in multidose containers.
The new guideline replaces and merges the ‘Note for guidance on in-use stability testing of veterinary medicinal products (excluding immunological veterinary medicinal products)’ (EMEA/CVMP/424/01) and the ‘Note for guidance on maximum shelf-life for sterile medicinal products after first opening or following reconstitution’ (EMEA/CVMP/198/99). Administrative changes are made in order to align the guideline with Regulation (EU) 2019/6 and the current EMA template for Guidance. The references to the applicable legislation and other scientific guidelines have also been updated. As no changes were made to the scientific content, no concept paper or public consultation were deemed necessary.
The continued integrity of products in multidose containers after the first opening/broaching is an important quality issue. This document attempts to define a framework for selection of batches, test design, test storage conditions, test parameters, test procedures etc., taking into consideration the broad range of products concerned.
Source:
EMA: In-use stability testing of veterinary medicinal products - Scientific guideline
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