Guidelines

Biologicals

Testing for the detection of Mycoplasma contamination
Impurities

VICH GL34 - Rev 1 at Step 9 (Biologicals-Quality) - November 2025 - For implementation at Step 7 in the regions by 1st April 2026

Download VICH GL34 (R1)-st7


Harmonisation of criteria to waive Target Animal Batch Safety Testing for live vaccines for veterinary use
Batch Safety Testing

VICH GL55 (Biologicals - TABST live vaccines) - May 2017 - for implementation in the regions at Step 7 by May 2018

Download GL55-st7


Target Animal Safety for Veterinary Live and Inactivated Vaccines
Target Animal Safety

VICH GL44 (TAS Biologicals) - July 2008 - Implemented in July 2009

Download GL44-st7.pdf


Target Animal Safety - Examination of Live Veterinary Vaccines in Target Animals for Absence of Reversion to Virulence - Annexes
Target Animal Safety

VICH GL41 (TAS Biologicals) July 2007 - Implemented in July 2008

Download GL41-st7.pdf


Harmonisation of criteria to waive Laboratory Animal Batch Safety Testing for vaccines for veterinary use
Batch Safety Testing

VICH GL 59 (Biologicals: LABST veterinary vaccines) - November 2020 - for implementation in the regions at Step 7 by November 2021

Download GL59-st7.pdf


Harmonisation of criteria to waive target animal batch safety testing for inactivated vaccines for veterinary use (Revision at Step 9)
Batch Safety Testing

VICH GL50 (R) (Biologicals - TABST inactivated vaccines) - May 2017 - for implementation in the regions at Step 7 by May 2018

Download GL50-R-st7.pdf


Test Procedures and Acceptance Criteria for New Biotechnological/Biological Veterinary Medicinal Products
Specifications

VICH GL40 (Biologicals - Quality) November 2005 - Implemented in November 2006


Stability testing of new biotechnological/biological veterinary medicinal products
Stability

VICH GL17 (Quality - Stability: biotechnologicals/biologicals) June 2000 - Implemented in July 2001

Download Gl17_st7.pdf


Testing of residual formaldehyde
Impurities

VICH GL25 (Biologicals: Formaldehyde) November 2000 - Implemented in May 2003

Download Gl25_st7.pdf


Testing of residual moisture
Impurities

VICH GL26 (Biologicals: Moisture) November 2000 - Implemented in May 2003

Download Gl26_st7.pdf