Methods found suitable within the European Union for demonstrating freedom from extraneous agents of
According to Directive 2001/82/EC and relevant European Pharmacopoeia (Ph. Eur.) monographs (i.e. 0062, 0030, 5.2.4., 5.2.5.), immunological veterinary medicinal products and materials of biological origin used in their production should be demonstrated to be free from contamination with extraneous agents.
#LegislationRegulatoryAffairs #RegulatoryAffairsVeterinary #GoodManufacturingPractices #LegislationQualityManagement