1. MATOSHRI COLLEGE OF PHARMACY,EKLAHARE,
NASHIK
Pharmaceutical Quality Assurance Department
A SEMINAR ON : CPCSEA GUIDELINES
SUBJECT:- QUALITY CONTROL AND QUALITY
ASSURANCE
(PQA 103T)
Presented by :
Guided by :
Mr . Pawase Amol
Roll No.13
Mrs. Varsha
Chaudhari
24-03-2025
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4. CPCSEA
GUIDELINES
MISSION
Mission of CPCSEA is to make sure that animals used in research are treated in Humane
and Ethical way.
AIM TO
Control
Animal
Research
Ensure
Ethical
Treatment
Follow Laws
Encourage
Alternatives
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6. INTRODUCTION :
It was originally established in 1964, under Chapter
4 Section 15 of the Prevention of Cruelty to
Animals (PCA) Act, 1960.
In 2022, the name of the committee was changed to the
Committee for Control and Supervision of Experiments
on Animals (CCSEA).
Under the dedicated leadership of Ms. Maneka
Gandhi.
Headquarter at New Delhi.
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7. CPCSEA composed of :
• Members of the scientific community
• Regulatory authorities
• Animal activists.
• The committee has 10 experts and 3 official members.
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8. FUNCTION OF CPCSEA :
Registration of the institution conducting
animal experimentation and breeding.
Approval of animal house facility.
Permission for conducting animal experiment – small and
big animals.
To permit import of animal for experimental
purpose .
Action against establishments , if non
compliance .
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9. GOALS AND OBJECTIVES :
The CPCSEA's primary goal is to promote
the human treatment of animals used in
research, education, and testing.
• Minimizing animal suffering.
• Ensuring scientific validity and quality.
• Building a collaborative environment.
The objective of CPCSEA is to ensure that
animals are not subjected to unnecessary
pains or suffering before, during or after
performance of experiments on them.
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13. As per the "Breeding of and
Experiments on Animals (Control
and Supervision) Rules, 1998"
RGCB has formed an Institutional
Animal Ethics Committee for
control and supervision of
experiments on animals performed
in the Institute.
The IAEC is registered with
the CPCSEA and its primary
duty is to review and approve
all types of research proposals
involving small animal
experimentation before the
start of the study.
The Committee also monitors
research throughout the study and
after completion of the study
through periodic reports besides
regular visits to the research
faculty animal house and
laboratories where the
experiments are conducted.
It also ensures compliance with
all regulatory requirements,
rules, guidelines and laws
related to animal experiments.
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15. The Institutional Biosafety Committee (IBC) is a group within an institution (such
as a university, research facility, or hospital) that is responsible for reviewing and
overseeing research or activities involving the use of biological materials,
recombinant DNA, or other potentially hazardous biological agents.
The committee ensures that research involving biological agents or recombinant
DNA
complies with safety regulations and ethical guidelines.
Its goal is to protect both individuals and the environment from potential
hazards associated with biohazardous materials.
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16. CPCSEA GUIDELINES FOR LABORATORY ANIMAL FACILITY
1.VETERINARY CARE :
Adequate veterinary care must be provided and is the responsibility of a veterinarian.
Daily observation of animals can be accomplished by someone other than a
veterinarian.
2.ANIMAL PROCUREMENT:
All Animals must be acquired lawfully as per the CPCSEA guidelines.
Small animals and dogs can be procured from registered breeders.
Large animals can be procured from farm, farmers or as per guidance of
wild life department.
Rodents can be imported from abroad after necessary license from Director
General of Foreign trade (DGFT) is obtained for import.
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3.QUARANTINE, STABILIZATION AND SEPARATION :
• Quarantine is the separation of newly received animals from those already in
the facility until the health and possibly the microbial status of the newly
received animals have been determined.
• An effective quarantine minimizes the chance for introduction of pathogens into
an established colony.
• The duration at quarantine in
small lab animals = one week to one
month large animals allowed up to 6 weeks
.
• However, duration of quarantine can be increased depending on type of
infection /
suspected infection noticed in the animals.
• Regardless of the duration of quarantine, newly received animals should be given
a period for physiologic, psychologic and nutritional stabilization before their use.
18. • Physical separation of animals by species is recommended to prevent
interspecies disease transmission and to eliminate anxiety and behavioral
changes .
4.SURVEILLANCE, DIAGNOSIS, TREATMENT AND CONTROL OF
DISEASE:
• All animals should be observed for signs of illness, injury, or abnormal behavior
by animal house staff.
• Unexpected deaths and signs of illness should be reported.
• Animals that show signs of a contagious disease should be isolated from
healthy animals in the colony.
5.ANIMAL CARE AND TECHNICAL PERSONNEL:
• Employ people Trained in Laboratory Animal Science .
• Healthcare professionals or expertise should handle Animals.
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19. 6.PERSONAL HYGIENE:
It is essential that the animal care staff maintain a high standard of
personal cleanliness.
Personnel should not be permitted to eat, drink, smoke or apply cosmetics
and perfumes in animal rooms.
7.ANIMAL EXPERIMENTATION INVOLVING HAZARDOUS AGENTS:
Institutions should have policies governing experimentation with
hazardous agents.
The procedures and the facilities to be used must be reviewed by both the
Institutional Bio-safety committee and Institutional Animal Ethics
Committee (IAEC).
8.MULTIPLE SURGICAL PROCEDURES ON SINGLE ANIMAL:
Multiple surgical procedures on a single animal for any testing or
experiment are not to be practiced unless specified in a protocol only approved
by the IAEC.
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20. 9.DURATIONS OF EXPERIMENTS:
No animal should be used for
experimentation for more than 3
years unless
adequate justification is provided.
10.PHYSICAL RESTRAINT:
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Prolonged restraint of any animal, including the chairing of non-human
primates, should be avoided unless essential to the research objectives. Less
restrictive systems, such as the tether system or the pole and collar system
should be used when compatible with research objectives.
22. • AIR CONDITIONING is an effective means of
regulating these environmental parameters for laboratory
animals.
• The range should be within or approximately between
18 to 29°C (64.4 to 84.2o F) all times.
• The relative humidity should be under control within
the range of 30% to 70% throughout the year.
• For larger animals a comfortable zone (18 to 37°C)
should
be maintained.
• Power And Lighting The electrical system should be
safe and provide appropriate lighting and with sufficient
number of power points lighting system be installed.
• Emergency power should be available in the event of
power failure.
• Noise Control – Noise free environment.
12.ENVIRONMENT:
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23. 13.ANIMAL HUSBANDRY:
• Caging of Housing System
• Adequate Ventilation.
• Meet the biological need of
the Animal.
• Keep the Animal dry
and Clean.
• Cages are made up of
steel.
14.FOOD:
• Animals should be fed with
palatable, non-contaminated,
and nutritionally adequate
food daily.
• Areas in which diets are
processed or stored should
be kept clean and enclosed to
prevent entry of insects or
other animals.
• Food should contain adequate
nutrition, with proper
formulation and preparation;
and ensure free from chemical
and microbial contaminants;
bio-availability of nutrients
should be as par with the
nutritional requirements of
the animal.
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24. 15.BEDDING:
• Bedding should be absorbent, free from toxic chemicals or other
substances that cause irritation, injure animals or personnel, and of a
type not readily eaten by animals.
• Bedding should be used in amounts sufficient to keep animals dry
between cage changes without coming into contact with watering tubes.
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25. 16.WATER:
Animals should have continuous access to fresh, potable,
uncontaminated drinking water, according to their requirements.
Periodic monitoring of microbial contamination in water is necessary.
17.SANITATION AND CLEANLINESS:
Sanitation is an essential activity in an animal facility. Animal
rooms, corridors, storage spaces, and other areas should be properly
cleaned with appropriate detergents and disinfectants as often as
necessary to keep them free of dirt, debris, and harmful agents of
contamination.
18.WASTE DISPOSAL:
Wastes should be removed regularly and frequently. All waste should
be collected and disposed off in a safe and sanitary manner.
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26. 19.RECORD KEEPING:
It is essential that animal House should maintain following records:
• Animal House plans, which includes typical floor plan, all fixtures etc.
• Animal House staff record - both technical and non – technical.
• Health record of staff and animals.
• All SOPs relevant to experiments, care, breeding and management of animals.
• Breeding, stock, purchase and sales records.
• Minutes of institutional Animals Ethics Committee Meetings.
• Records of experiments conducted with the number of animals used.
• Mortality, Post-mortem Record, wherever required.
• Clinical record of sick animals.
• Training record of staff involved in animal activities .
• Water, feed and bedding materials analysis report .
• Health monitoring Records.
• Rehabilitation Records, wherever required.
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27. 20.EMERGENCY, WEEKEND AND HOLIDAY CARE:
• There should be an institutional policy to care animals by qualified
personnel every day, including weekends and holidays, to safeguards their
well - being including emergency veterinary care.
21.STANDARD OPERATING PROCEDURES (SOPs):
• The Institute should maintain SOPs describing procedures / methods adapted
with regard to Animal Husbandry, maintenance, breeding, animal house activities
microbial testing and experimentation.
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A SOP should contain the following items:
Name of the Author
Title of the SOP
Date of approval
Reference of previous SOP on the same subject and date (Issue number and Date)
Location and distribution of SOP’s with sign of each recipient.
Objectives
Detailed information of the instruments used in relation with animals with
methodology (Model no., Serial no., Date of commissioning, etc)
Normal value of all parameters
Hazard identification and risk assessment
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ANAESTHESIA :
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• To the achievement of the results of study, sedatives, analgesics and anaesthetics
should be used to control pain or distress under experiment.
• Anaesthetic agents generally affect cardiovascular, respiratory and
thermo- regulatory mechanism in addition to central nervous system.
• Local or general anaesthesia may be used, depending on the type of surgical
procedure.
• Local anaesthetics are used to block the nerve supply to a limited area and are
used only for minor and rapid procedures. This should be carried out under
an expert supervision.
• A number of general anaesthetic agents are used in the form of inhalants.
General anaesthetics are also used in the form of intravenous or intra-
muscular injections such as barbiturates.
31. EUTHANASIA:
• Euthanasia is comes from a Greek word meaning Good Death.
• Euthanasia should be resorted to events where an animal is required to be
sacrificed to reduce suffering or to limit spread of infections or for
termination of an experiment or for other ethical reasons.
• The procedure should be carried out quickly and painlessly in an
atmosphere free from fear or anxiety.
• Death, without causing anxiety, pain or distress with minimum time lag
phase
Due to Euthanasia.
• Tranquilizers have to be administered to larger species such as monkeys,
dogs and cats before a procedure of euthanasia.
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