(1993; 36 pages)
5. Animal quarters and care1
1 General requirements for animal quarters, care and quarantine are given in reference 4.
5.1 Animals are used for the manufacture and control of a number of biological products. Animals shall be accommodated in separate buildings with self-contained ventilation systems. The buildings’ design and construction materials shall permit maintenance in a clean and sanitary condition free from insects and vermin. Facilities for animal care shall include isolation units for quarantine of incoming animals and provision for vermin-free food storage. Provision shall also be made for animal inoculation rooms, which shall be separate from the postmortem rooms. There shall be facilities for the disinfection of cages, if possible by steam, and an incinerator for disposing of waste and of dead animals.
5.2 The health status of animals from which starting materials are derived and of those used for quality control and safety testing should be monitored and recorded. Staff employed in animal quarters must be provided with special clothing, changing facilities and showers. Where monkeys are used for the production or quality control of biological products, special consideration is required, as laid down in the revised Requirements for Biological Substances No. 7 (Requirements for Polio myelitis Vaccine (Oral)) (5).