The document outlines the facility requirements for conducting a GLP study using animals. Key requirements include: 1) The animal research facility must carefully control environmental parameters like temperature, humidity, and light to minimize effects on animals and prevent contact between animals of different studies or with unintended test items. 2) Experimental rooms must be individually ventilated with strict separation of clean and dirty areas, and maintain standards for lighting, noise, and air exchanges. 3) The facility must have provisions for quarantine, housing, feeding, watering, bedding, caging, necropsy, storage, and documentation in accordance with species-specific standards. 4) Detailed standard operating procedures must be maintained and

1. Facility Requirements to Initiate the GLP Study
By: Vishnu Jatoth
M.S (Pharm) Regulatory Toxicology

2. Animal Research Facility
• Facility should be designed and operated to control selected parameters (such as temperature,
humidity and light) to minimize the effects of environmental variables on the animal.
• In addition, the facility should be organized in a way that prevents the animals from coming
into contact with disease, or with a test item other than the one under investigation.
• Animal research facility should have separations maintained by species, studies, quarantine
change rooms, receipt of test materials and its storage, feed and bedding, cage washing area,
necropsy and waste disposal

3. Animal Research Facility (Cont…)
• The environment control system should maintain the temperature, humidity and airflow
constantly at the defined levels for the species concerned
• Entry to animal research facility should be restricted to only the staff dedicated to work in the
animal rooms
• The staff should use dedicated personnel protective like coat, gloves, face mask, cap etc.
• Outside foot wares should not be allowed inside the animal research facility.
• There should be clean and dirty corridors

4. Experimental Rooms
• Entry into the animal research facility should be through air shower.
• Animal Research Facility for experimentation should be minimum number of rooms,
individually ventilated with 10 to 15 air exchanges/hr, 400-450 lux illumination with 12
hour light and dark cycles and sound within 85 decibel
• Barrier maintained with clean and service corridors.
• There should be separate feed and bedding storage one room each
• Washing area with big autoclave facility
• Separate Necropsy area for post-mortem
• There should be minimum two quarantine rooms

5. Experimental Rooms (Cont…)
• Separate laboratories for Biochemistry and Histology
• Independent Histopathologist for slide observations
• Separate Wet and Dry Archiving facility
• Test and Reference item control Office
• Refrigerated storage and/or freezer
• Backup facility for electricity failure
• Reagent preparation and formulation room
• Administrative work spaces for Test Facility Management/Study Directors/Document
Control/Quality Assurance/IT-Data Entry and Statistics/Purchase and Finance etc.

6. Quarantine
• A minimum duration of quarantine for small lab animals is one week and larger animals is
6 weeks (cat, dog and monkey)
• There should be separate one or two quarantine rooms where animals can be quarantined
and observed for clinical signs and found any diseased animals can be treated before it is
used for any experimental purpose
• All records of quarantine along with the veterinary certificate should be the part of study
raw data.

7. Caging or housing system
The caging or housing system is one of the most important elements in the physical and
social environment of research animals. It should be designed carefully to facilitate animal
well being, meet research requirements, and minimize experimental variables
Provide space that is adequate, permit freedom of movement and normal postural
adjustments, and have a resting place appropriate to the species

8. Recommended floor area per animal (cm²)
Species Floor area per
animal (cm²)
Weight of animal (g) Max. No.
Animal
Cage Hight
(cm²)
Rats
109.6 <100 6
12
148.3 200 5
187.0 300 4
258.0 400 3
Mice
38.7 <10 8
14
51.6 Upto 15 7
77.4 Upto 25 4
96.7 >25 3

9. Water, Feed & Bedding
Water: Animals should have continuous access to fresh, potable, uncontaminated
drinking water, according to their particular requirements. Periodic monitoring of
microbial contamination in water is necessary
Feed: Animals should be fed palatable, non-contaminated, and nutritionally adequate
food daily unless the experimental protocol requires otherwise
• Feeders should allow easy access to food, while avoiding contamination by urine and
feces
Bedding: Bedding should be absorbent, free of toxic chemicals or other substances that
could injure animals or personnel, and of a type not readily eaten by animals

10. Species wise temperature and Humidity Requirements
Species Temperature (oC) Humidity (%)
Mice 22±3
30-70
Rats 22±3
Guinea Pigs 20±3
Rabbits 20±3
• Facility should be Capable to provided variations within the range of temperature
approximately 18 to 29°C, which includes the temperature ranges usually recommended
for common laboratory animals.
• For larger animals a comfortable zone 18 to 37°C

11. STANDARD OPERATING PROCEDURES
• The Organization shall maintain SOPs describing procedures / methods adapted with regard to
experiments, animal husbandry, maintenance, breeding, animal house microbial analysis and
experimentation records
• SOP should contain the following items:
Name of the Author
Title of the SOP
Date of preparation
Reference of previous SOP on the same subject and date (Issue no and Date)
Location and distribution of SOPs with sign of each recipient
Objectives
Detailed information of the instruments used in relation with animals with methodology (Model
no., Serial no. and Date of commissioning)
The name of the manufacturer of the reagents and the methodology of the analysis pertaining to
animals
Normal value of all parameters

12. CPCSEA & IAEC Approval
• Facility Should be CPCSEAAccreditation
• Use of animals in GLP study should have IAEC approval with protocol number
Composition of IAEC: IAEC shall consist of 5 (Five) names (all from science background
including one Veterinarian). The composition should be as under
• A Biological Scientist.
• Two Scientists from different biological disciplines.
• A Veterinarian involved in the care of Animals.
• Scientist In-Charge of Animal House Facility

13. Thank You