European Pharmacopoeia

EUROPEAN PHARMACOPOEIA 5.1

5.2.2. SPF chicken flocks for vaccines

04/2005:50202 prior to the designated SPF flock. A general scheme for the procedure to be followed in establishing and maintaining an SPF flock is shown diagrammatically in Table 5.2.2.-2. In 5.2.2. CHICKEN FLOCKS FREE order to establish a new SPF flock, a series of tests must be FROM SPECIFIED PATHOGENS FOR conducted on 3 generations of birds. All birds in the first generation must be tested at least once before the age of THE PRODUCTION AND QUALITY 20 weeks for freedom from avian leucosis group-antigen CONTROL OF VACCINES and tested by an enzyme immunoassay (EIA) for freedom of antibodies to avian leucosis virus subtypes A, B and J. Where specified, chickens, embryos or cell cultures used All birds must also be tested for freedom from antibodies for the production or quality control of vaccines are to the vertically-transmissible agents listed in Table 5.2.2-1. derived from eggs produced by chicken flocks free from From the age of 8 weeks the flock is tested for freedom from specified pathogens (SPF). The SPF status of a flock is Salmonella. Clinical examination is carried out on the flock ensured by means of the system described below. The list of from 8 weeks of age and the birds must not exhibit any signs micro-organisms given is based on current knowledge and of infectious disease. The test methods to be used for these will be updated as necessary. tests are given in the table and further guidance is also given in the section below on routine testing of designated SPF A flock is defined as a group of birds sharing a common flocks. From 20 weeks of age, the flock is tested as described environment and having their own caretakers who have no under Routine testing of designated SPF flocks. All stages contact with non-SPF flocks. Once a flock is defined, no of this testing regime are also applied to the subsequent non-SPF birds are added to it. 2 generations, except the testing of every bird...