Guidelines

Quality

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


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