This content is current only at the time of printing. This document was printed on 28 July 2021. A current copy is located at https://apvma.gov.au/definition-of-terms/3
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Definition of terms
|3-batch analysis (in veterinary medicines)||
An analysis for active constituent, isomers and impurities content carried out on three separate batches of production material. This analysis provides evidence that the material conforms to the specifications, ie it is within the certified manufacturing limits. The analysis of three batches for veterinary medicines (compared with a 5-batch analysis in pesticides) accounts for the fact that veterinary medicines manufacture has requirements for compliance with Good Manufacturing Practice and published standards.