1.0 OBJECTIVE
1.1
To lay down a standard procedure to be followed for the supply of laboratory animals to different
studies in Animal House Facility.
2.0
SCOPE
2.1
This Standard Operating Procedure (SOP) shall be
applicable for supply of laboratory animals from Animal
House Facility to different studies conducted in Animal House Facility.
3.0
RESPONSIBILITY
3.1
Head- Animal House Facility
4.0
DEFINITIONS
4.1
Nil
5.0
PROCEDURE
5.1
Supply of animals
to study
5.1.1
Animals shall be issued by the
Animal facility in-charge to the IAEC approved studies on request by the Study
Director /Principal Investigator in the duly filled requisition format No- F………..
titled “Animal Requisition, Receipt and Issue form”. The original form shall
remain with the animal facility and photocopy of this received form shall be
provided to the respective Study Director / Principal Investigator with the
remark “received” with the date and signature of the person receiving.
5.1.2 The requisition orm shall be
submitted well in advance so as to enable proper planning of the supply of animals.
5.1.3
In case of unavailability of
animals, the Animal facility in-charge shall inform to Study Director /
Principal Investigator for a tentative date of issue as per breeding or
procurement schedule.
5.1.4
If needed, animals shall be
procured from known commercial sources registered with CPCSEA or any other
legal source.
5.1.5
Animals shall be supplied along
with animal health records and animal requisition, receipt, and issue forms. On
receipt of animals along with animal health record and animal requisition,
receipt, and issue form, The Study Director / Designee shall accept these animals
by signing in the animal health record form. The original animal health record
and animal requisition, receipt, and issue form shall remain with the small
animal facility and a photocopy of same shall be provided to Study Director.
5.1.6
Animals shall be carefully
examined as mentioned below at the time of issue for study.
5.1.7
Observation of animals shall be
filled in the currently running version of the form tilted “Animal Health
Examination Record”, Format No.: F………… to the currently running version with
declaration note on the health status of the animals.
5.1.8
Movement and transfer of laboratory
animals in the animal facility shall be carried out as per the currently running version of the SOP………..
5.2
Identification
of animals supplied to the study
5.2.1
Animals shall be numbered with the temporary number on the tail/body for rat/mouse and inner ear (rabbit) with a pen
marker for identification when supplied to the study.
5.2.2
Cage cards/ear punching/notching
shall be used for identification of animals for which temporary numbering with
pen marker is not possible because of its coat color.
5.3
Examination of animals
5.3.1
In an animal facility, it is
necessary to examine animals on daily basis to rule out the possibility of
diseases, gross abnormalities, physiological distress, and ill health. Trained
laboratory assistants shall take care of the animals daily under the
supervision of the Animal house-in charge.
5.3.2
Animal looking debilitated shall
be considered as unhealthy or vulnerable to disease as compared to the
healthier ones that are active.
5.3.3
Fecal material in the cage shall
be noted for its consistency. As a general rule as much of a clinical
examination as possible shall be carried out before the animal is handled. This
partly avoids unnecessary excitement of animals. Also, some abnormalities are
better seen at a distance and in some cases can’t be discerned at close range.
5.3.3.1
The examination of animals consists of a
general inspection followed by a physical examination. The animals shall be
examined in the following aspects:
5.3.3.2
Animal behavior
5.3.3.2.1
The behavior of the animal inside the cage and to
external stimuli give an idea about the general health of the animal.
5.3.3.3
Posture
5.3.3.3.1
Abnormal posture is not necessarily indicative of
disease but when associated with other signs it may indicate the site and the severity of disease process.
5.3.3.4
Gait
5.3.3.4.1
Movement of the limbs shall be expressed in terms of
rate, range, force, and direction of movement. Circling is a common abnormality
and is usually associated with rotation or twisting of the head.
5.3.3.5
Skin Coat
5.3.3.5.1
The animals shall be examined to observe their normal
condition, obese, thin, or emaciated.
5.3.3.5.2
In an emaciated (cachectic) animal, the coat shall be
observed for any poor/rough surface, dry and leathery skin. Skin abnormalities
shall be usually seen at a distance, they include the presence of discrete or
diffuse lesions and evidence of spoilage by discharge and itching.
5.3.3.6
Respiration
5.3.3.6.1
The animal shall be observed for respirations to rule
out the possibilities of any abnormal respiration.
5.3.3.7
Responsiveness
5.3.3.7.1
The animal’s responsiveness inside the cage and to
external stimuli or handling gives an idea about the general health of the
animal.
5.3.3.8
Eye
5.3.3.8.1
The eyes, eyelids, conjunctivae, cornea, pupil, and iris
shall be examined carefully to know the condition by using the penlight.
Normal mucous membrane shall be pale pinkish and moist. A dark pink
discoloration of the mucous membrane indicates capillary congestion or
dilatation, while pallor indicates anemia or capillary constrictions.
5.3.3.8.2
Any unilateral or bilateral discharge from the eyes
shall be examined. The condition of the eyelids and conjunctiva shall be
observed. In sick animals, they may be closed, droopy or soiled.
5.3.3.9
Ear
5.3.3.9.1
Ears shall be examined for any kind of abnormal
discharge or secretions etc.
5.3.3.10
Abdomen
5.3.3.10.1
It shall be examined visually and by palpation for the
presence of cysts, injuries, lesions, and abnormal growth/masses, etc.
5.3.3.11
Body Region
5.3.3.11.1
Body regions other than the abdomen shall be carefully
examined visually and by palpation for any abnormal growth/masses, injuries and
lesions etc.
5.3.3.12
Limbs
5.3.3.12.1
The limbs shall be observed for locomotor disturbances,
injuries, lesions, and deformities, etc. In addition to the above examination, the
act of urination and defecation shall be observed when the animal is being
handled. The nose shall be examined for any kind of abnormal discharge. The mouth shall
be examined for any ulcerative lesions, injuries, etc. Teeth shall be observed
for defective teeth or malocclusions etc. External Genitalia shall be observed
for any abnormal discharges.
5.3.3.12.2
Any abnormal finding, if present shall be documented
and the animal(s) shall be transferred to the sick room. Sick animals shall be
subjected to appropriate diagnosis and treatment and records shall be documented
in Format No. F……………..
5.3.3.12.3
The above-stated animal health examination procedure
shall be performed by designated staff / visiting veterinary doctor weekly once
or as and when required.
5.3.3.12.4
Animal health examination record shall be documented in
the Format No: F………………..
5.3.3.13
Note: If a physical examination shows any abnormality, the animal shall be
isolated and such animals shall not be issued to the study. If animals show
severe signs of pain and distress, as well as being suspected for any disease
or carrier of disease shall be euthanized.
6.0 ENCLOSURES
6.1 Formats
|
Sr. No. |
Format Title |
Format No |
No. of Pages |
|
1. |
Animal Health Examination Record |
F……………. |
01 |
|
2. |
Sick Animal(s) Treatment Record |
F……………. |
01 |
|
3. |
Animal Requisition, Receipt and Issue Form |
F……………. |
01 |
|
4. |
Animal Return Record For Used / Unused Animals |
F……………. |
01 |
7.0 ABBREVIATIONS
7.1
SOP : Standard Operating Procedure
7.2
QAD : Quality Assurance Department
7.3 AHF : Animal House Facility
8.0 REFERENCES
8.1
Committee
for the purpose of control and supervision of experiments on animals (CPCSEA)
guidelines for laboratory animal facility-2005, CPCSEA, Standard Operating
Procedures for Institutional Animal Ethics Committee (IAEC), Animal Welfare
Division, Ministry of Environment and Forests, January, 2010 .
8.2
The
Handbook of Experimental Animals, The Laboratory Mouse, Hans Hedrich and
Gillian Bullock, Elsevier Academic Press, 2004.
8.3
The
Laboratory Rat, Mark A. Suckow, Steven H. Weisbroth and Craig L. Franklin,
Second Edition, American College of Laboratory Animal Medicine Series, Elsevier
Academic Press, 2006.
8.4 Handbook of Laboratory Animal Management and Welfare, Sarah Worfenson and Maggie Llyod, Second Edition, Blackwell Science, 1998.
9.0 REVISION HISTORY
|
Sr. No. |
Change Control No. |
Reason for change |
|
|
|
|
END OF
DOCUMENT
You may like to read these links:
1. List of All SOPs and Documents for Microbiology Laboratory
2. List of All SOPs and Documents for In-vitro Laboratory
3. List of All SOPs and Documents for In-vivo Laboratory.
4. List of All SOPs and Documents for Clinical Research
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