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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Facilities

Comparison of FDA, EPA, OECD GLP Facilities
Topic FDA EPA OECD
General Facility
Requirements
58.41
Each testing facility shall be of suitable size and construction to facilitate the proper conduct of nonclinical laboratory studies. It shall be designed so that there is a degree of separation that will prevent any function or activity from having an adverse effect on the
study.
792.41
Each testing facility shall be of suitable size and construction to facilitate the proper conduct of studies. Testing facilities which are not located within an indoor controlled environment shall be of suitable location to facilitate the proper conduct of studies. Testing facilities shall be designed so that there is a degree of separation that will prevent any function or activity from having an adverse effect on the study.
Section II
3.1.1. The test facility should be of suitable size, construction and location to meet the requirements of the study and to minimise disturbance that would interfere with the validity of the study. 3.1.2. The design of the test facility should provide
Animal Care
Facilities -
Animal Rooms
58.43
  1. A testing facility shall have a sufficient number of animal rooms or areas, as needed, to assure proper:
    1. Separation of species or test systems,
    2. isolation of individual projects,
    3. quarantine of animals, and
    4. routine or specialized housing of animals.
792.43
  1. A testing facility shall have a sufficient number of animal rooms or other test system areas, as needed, to ensure: proper separation of species or test systems, isolation of individual projects, quarantine or isolation of animals or other test systems, and routine or specialized housing of animals or other test systems.
    1. In tests with plants or aquatic animals, proper separation of species can be accomplished within a room or area by housing them separately in different chambers or aquaria. Separation of species is unnecessary where the protocol specifies the simultaneous exposure of two or more species in the same chamber, aquarium, or housing unit.
    2. Aquatic toxicity tests for individual projects shall be isolated to the extent necessary to prevent cross-contamination of different chemicals used in different tests.
Section II
3.2.1 The test facility should have a sufficient number of rooms or areas to assure the isolation of test systems and the isolation of individual projects, involving substances or organisms known to be or suspected of being biohazardous.
Animal Care
Facilities -
Isolation of
Biohazardous
Agents
58.43
(b) A testing facility shall have a number of animal rooms or areas separate from those described in paragraph (a) of this section to ensure isolation of studies being done with test systems or test and control articles known to be biohazardous, including volatile substances, aerosols, radioactive materials, and infectious agents.
792.43
(b) A testing facility shall have a number of animal rooms or other test system areas separate from those described in paragraph (a) of this section to ensure isolation of studies being done with test systems or test, control, and reference substances known to be biohazardous, including volatile substances, aerosols, radioactive materials, and infectious agents.
Section II
3.2.1 The test facility should have a sufficient number of rooms or areas to assure the isolation of test systems and the isolation of individual projects, involving substances
or organisms known to be or suspected of being biohazardous.
Animal Care
Facilities -
Disease Control
Areas
58.43
(c) Separate areas shall be provided, as appropriate, for the diagnosis, treatment, and control of laboratory animal diseases. These areas shall provide effective isolation for the housing of animals either known or suspected of being diseased, or of being carriers of disease, from other animals.
792.43
(c) Separate areas shall be provided, as appropriate, for the diagnosis, treatment, and control of laboratory test
system diseases. These areas shall provide effective isolation for the housing of test systems either known or suspected of being diseased, or of being carriers of disease, from other test systems.
Section II
3.2.2. Suitable rooms or areas should be available for the diagnosis, treatment and control of diseases, in order to ensure that there is no unacceptable degree of deterioration of test systems.
Animal Care
Facilities -
Waste Disposal
58.43
(d) When animals are housed, facilities shall exist for the collection and disposal of all animal waste and refuse or for safe sanitary storage of waste before removal from the testing facility. Disposal facilities shall be so provided and operated as to minimize vermin infestation, odors, disease hazards, and environmental contamination.
792.43
(d) Facilities shall have proper provisions for collection and disposal of contaminated water, soil, or other spent materials. When animals are housed, facilities shall exist for the collection and disposal of all animal waste and refuse or for safe sanitary storage of waste before removal from the testing facility. Disposal facilities shall be so provided and operated as to minimize vermin infestation, odors, disease hazards, and environmental contamination.
Section II
3.5. Handling and disposal of wastes should be carried out in such a way as not to jeopardise the integrity of studies. This includes provision for appropriate collection, storage and disposal facilities, and decontamination and transportation procedures.
Animal Care -
Animal Supply
Storage
58.45
There shall be storage areas, as needed, for feed, bedding, supplies, and equipment. Storage areas for feed and bedding shall be separated from areas housing the test systems and shall be protected against infestation or contamination. Perishable supplies shall be preserved by appropriate means.
792.45
  1. There shall be storage areas, as needed, for feed, nutrients, soils, bedding, supplies, and equipment. Storage areas for feed, nutrients, soils, and bedding shall be separated from areas where the test systems are located and shall be protected against infestation or contamination. Perishable supplies shall be preserved by appropriate means.
  2. When appropriate, plant supply facilities shall be provided. These include:
    1. Facilities, as specified in the protocol, for holding, culturing, and maintaining algae and aquatic plants.
    2. Facilities, as specified in the protocol, for plant growth, including but not limited to, greenhouses, growth chambers, light banks, and fields.
  3. When appropriate, facilities for aquatic animal tests shall be provided. These include but are not limited to aquaria, holding tanks, ponds, and ancillary equipment, as specified in the protocol.
Section II
3.2.3. There should be storage rooms or areas as needed for supplies and equipment. Storage rooms or areas should be separated from rooms or areas housing the test systems and should provide adequate protection against infestation, contamination and/or deteroriation.
Animal Care
Facilities -
Environmental
Control
  792.43
(e) Facilities shall have provisions to regulate environmental conditions (e.g., temperature, humidity, photoperiod) as specified in the protocol.
 
Animal Care
Facilities -
Marine Test
Organisms
. 792.43
(f) For marine test organisms, an adequate supply of clean sea water or artificial sea water (prepared from deionized or distilled water and sea salt mixture) shall be available. The ranges of composition shall be as specified in the protocol.
 
Animal Care
Facilities -
Freshwater Test
Organisms
  792.43
(g) For freshwater organisms, an adequate supply of clean water of the appropriate hardness, pH, and temperature, and which is free of contaminants capable of interfering with the study shall be available as specified in the protocol.
 
Animal Care
Facilities -
Plants
  792.43
(h) For plants, an adequate supply of soil of the appropriate composition, as specified in the protocol, shall be available as needed.
 
Facilities for
Handling Test &
Control Aritcles
58.47
  1. As necessary to prevent contamination or mixups, there shall be separate areas for:
    1. Receipt and storage of the test and control articles.
    2. Mixing of the test and control articles with a carrier, e.g., feed.
    3. Storage of the test and control article mixtures.
792.47
  1. As necessary to prevent contamination or mixups, there shall be separate areas for:
    1. Receipt and storage of the test, control, and reference substances.
    2. Mixing of the test, control, and reference substances with a carrier, e.g., feed.
    3. Storage of the test, control, and reference substance mixtures.
Section II
3.3.1. To prevent contamination or mix-ups, there should be separate rooms or areas for receipt and storage of the test and reference items, and mixing of the test items with a vehicle.
Test & Control
Aritcle Storage
Areas
58.47
(b) Storage areas for the test and/or control article and test and control mixtures shall be separate from areas housing the test systems and shall be adequate to preserve the identity, strength, purity, and stability of the articles and mixtures.
792.47
(b) Storage areas for test, control, and/or reference substance and for test, control, and/or reference mixtures shall be separate from areas housing the test systems and shall be adequate to preserve the identity, strength, purity,
Section II
3.3.2. Storage rooms or areas for the test items should be separate from rooms or areas containing the test systems. They should be adequate to preserve identity, concentration, purity, and stability, and ensure safe storage for hazardous substances.
Laboratory
Operation
Areas
58.49
Separate laboratory space shall be provided, as needed, for the performance of the routine and specialized procedures required by nonclinical laboratory studies.
792.49
Separate laboratory space and other space shall be provided, as needed, for the performance of the routine and specialized procedures required by studies.
 
Archives 58.51
Space shall be provided for archives, limited to access by authorized personnel only, for the storage and retrieval of all raw data and specimens from completed studies.
792.51
Space shall be provided for archives, limited to access by authorized personnel only, for the storage and retrieval of all raw data and specimens from completed studies.
Section II
3.4. Archive facilities should be provided for the secure storage and retrieval of study plans, raw data, final reports, samples of test items and specimens. Archive design and archive conditions should protect contents from untimely deterioration.