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The Good Laboratory Practice Regulations 1999

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Care, housing and containment of biological test systemsU.K.

6.—(1) Purpose: to determine whether the test facility, if engaged in studies using animals or other biological test systems, has support facilities and conditions for their care, housing and containment which are adequate to prevent stress and other problems which could affect the test system and hence the quality of data.

(2) A test facility may be carrying out studies which require a diversity of animal or plant species as well as microbial or other cellular or sub-cellular systems. The type of test systems being used will determine the aspects relating to care, housing or containment that the inspector will monitor. Using his judgment, the inspector will check, according to the test systems, that—

  • —there are facilities adequate for the test systems used and for testing needs,

  • —there are arrangements to quarantine animals and plants being introduced into the facility and that these arrangements are working satisfactorily,

  • —there are arrangements to isolate animals (or other elements of a test system, if necessary) known to be, or suspected of being, diseased or carriers of disease,

  • —there is adequate monitoring and record-keeping of health, behaviour or other aspects, as appropriate to the test system,

  • —the equipment for maintaining the environmental conditions required for each test system is adequate, well-maintained, and effective,

  • —animal cages, racks, tanks and other containers, as well as accessory equipment, are kept sufficiently clean,

  • —analyses to check environmental conditions and support systems are carried out as required,

  • —facilities exist for removal and disposal of animal waste and refuse from the test systems and that these are operated so as to minimise vermin infestation, odours, disease hazards and environmental contamination,

  • —storage areas are provided for animal feed or equivalent materials for all test systems, that these areas are not used for the storage of other materials such as test items, pest control chemicals or disinfectants, and that they are separate from areas in which animals are housed or other biological test systems are kept,

  • —stored feed and bedding are protected from deterioration by adverse environmental conditions, infestation or contamination.

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