Paragraph 8 Test systems

Purpose: to determine whether adequate procedures exist for the handling and control of the variety of test systems required by the studies undertaken in the facility, for example, chemical and physical systems, cellular and microbic systems, plants or animals.

As regards physical and chemical systems, the inspector should check that—

• —where required by study plans, the stability of test and reference items was determined and that the reference items specified in test plans were used,

• —in automated systems, data generated as graphs, recorder traces or computer print-outs are documented as raw data and archived.

As regards biological test systems, taking account of the relevant aspects referred to above relating to care, housing or containment of biological tests systems, the inspector should check that—

• —test systems are as specified in study plans,

• —test systems are adequately and, if necessary and appropriate, uniquely identified throughout the study, and that records exist regarding receipt of the test systems and document fully the number of test systems received, used, replaced or discarded,

• —housing or containers of test systems are properly identified with all the necessary information,

• —there is an adequate separation of studies being conducted on the same animal species (or the same biological test system) but with different items,

• —there is an adequate separation of animal species (and other biological test systems) either in space or in time,

• —the biological test system environment is as specified in the study plan or in standard operating procedures for aspects such as temperature, or light/dark cycles,

• —the recording of the receipt, handling, housing or containment, care and health evaluation is appropriate to the test systems,

• —written records are kept of examination, quarantine, morbidity, mortality, behaviour, diagnosis and treatment of animal and plant test systems or other similar aspects as appropriate to each biological test system,

• —there are provisions for the appropriate disposal of test systems at the end of tests.