Paragraph 5 Facilities

Purpose: to determine if the test facility, whether indoor or outdoor, is of suitable size, design and location to meet the demands of the studies being undertaken.

The inspector should check that—

• —the design enables an adequate degree of separation so that, for example, test substances, animals, diets, pathological specimens etc. of one study cannot be confused with those of another,

• —environmental control and monitoring procedures exist and function adequately in critical areas, for example, animal and other biological test systems rooms, test item storage areas, laboratory areas,

• —the general housekeeping is adequate for the various facilities and that there are, if necessary, pest control procedures.