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Directive 2004/9/EC of the European Parliament and of the CouncilShow full title
Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) (Codified version) (Text with EEA relevance)
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- Directives originating from the EU
- 2004 No. 9
- ANNEX I
- PART B
- Biological test systems
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- Revised 26/07/20190.29 MB
- Revised 20/04/20090.10 MB
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Changes over time for: Biological test systems
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Biological test systemsU.K.
Taking account of the relevant aspects referred to above relating to care, housing or containment of biological test 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 systems) but with different substances,
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 SOPs 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.
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