Whenever possible, animals used in the manufacture of biotechnological/biological products should be obtained from well defined, specific pathogen-free colonies. Adequate testing for appropriate viruses, such as those listed in Table 3
, should be performed. Quarantine procedures for newly arrived as well as diseased animals should be described, and assurance provided that all containment, cleaning, and decontamination methodologies employed within the facility are adequate to contain the spread of adventitious agents. This may be accomplished through the use of a sentinel program. A listing of agents for which testing is performed should also be included. Veterinary support services should be available on-site or within easy access. The degree to which the vivarium is segregated from other areas of the manufacturing facility should be described. Personnel practices should be adequate to ensure safety.