VICH GL34 Biologicals: testing for the detection of Mycoplasma contamination - Scientific guideline

This document provides guidance on testing for the presence of Mycoplasma contamination in cell culture and in ovo origin biological products for veterinary use. It addresses tests on master seeds, master cell seeds (stocks), working seeds and cells, ingredients of animal origin, harvests and live final vaccine and harvests for killed products.

Keywords: VICH, mycoplasma, biologicals, contamination

Current effective version

International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products GL34: Biologicals: testing for the detection of Mycoplasma contamination

AdoptedReference Number: EMA/CVMP/VICH/463/2002Summary:

This VICH (International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products) guideline is intended to facilitate the harmonized licensing of new products for veterinary use.

Document history

Draft VICH GL34: Biologicals: testing for the detection of mycoplasma contamination

Draft: consultation closedConsultation dates: 08/12/2011 to 12/03/2012Reference Number: EMA/CVMP/VICH/463/2002

VICH GL34: Guideline on testing for the detection of mycoplasma contamination

Draft: consultation closedConsultation dates: 09/12/2010 to 31/03/2011Reference Number: EMA/CVMP/VICH/463/02