PREPARED BY-SUBODH SHAH
PHARMACOLOGICAL AND
TOXICOLOGICAL SCREENING
CPCSEA
 Committee for the Purpose of Control and Supervision of
Experiments on Animals (CPCSEA).
 Statutory body formed by the Act of the Indian Parliament
under the Prevention of Cruelty to Animals Act, 1960 .
 Formed in 1964 .
 Revived in 1998, under the committed chairpersonship of
Meneka Gandhi .
 Head quarters at Chennai .
 Includes various guidelines and sub committees.
CPCSEA
 National level expert committee to scrutinize and approve
the research projects conducted using animals.
 Introduced a national “Good Laboratory Practice”
documen.
 Introduced the credo of 3R principles.
 2004 – CPCSEA officially accepts the concept of the 4th R.
“investigators have a moral responsibility to take care of
laboratory animals after use”.
CPCSEA
This committee is composed of
 Members of the scientific community .
 Regulatory authorities .
 Animal activists.
 The committee has 10 experts and 3 official members.
CPCSEA guidelines
CPCSEA and IAEC
Role of CPCSEA is to monitor animal experiments
through ethics committees set up in
institutions(IAEC).
CPCSEA Nominee –important link between CPCSEA
and IAEC.
IAEC scrutinize all project proposals for
experimentation onFor small animals.
 give the final approve .
For large animals- make its recommendation to SCLA
(Sub-Committee on Large Animals) animals.
IAEC composition
--A Biological Scientist.
--Two Scientists from different bio disciplines.
--A Veterinarian involved in care of Animals.
--Scientist In-Charge of Animal House Facility.
The Chairman (preferably Head of the Institution /
Department) and Member Secretary need to be
nominated from the above five members.
Other members : Main Nominee, Link Nominee,
Scientist from outside and Socially Aware Nominee
nominated by CPCSEA.
The validity of IAEC is for 3 years.
CPCSEA
goals:
 To promote the humane care of animals used in research.
 To provide specifications that will enhance animals well
being and quality of research.
Objective: Effective functioning of Institutional
animal ethical committee.
Main Activities
Registration of establishments .
 for experiments on animals .
 for Breeding of animals .
Approval of Animal House Facilities .
Permission of Committee for Conducting Experiments.
CPCSEA guidelines
Veterinary care:
 Provided by a veterinarian.
 Daily observation of animals adopted Quarantine,
Stabilization and Separation:
Quarantine period for small lab animal
 one wk to one mth- large lab animals : up to 6 weeks.
 Physiologic, psychological and nutritional stabilization
required .
 Physical separation of animals by species to prevent
anxiety and behavioral changes.
Animal procurement and
tranportation
Procurement of animals done from established commercial
animal vendors.
 During transport, stress avoided by: Use of transport
containers (cages or crates) of appropriate size .
 Permissible number of animals accommodated in each
container.
Experimental area:
Experiments should be carried out in a separate area away
from the place where they are housed.
Separate functional areas for .
 surgical support.
 treatment of animals.
 post operative and intensive care.
PHYSICAL FACILITIES
 BUILDING MATERIALS-
moisture-proof, fire-resistant, seamless materials are most
desirable for interior surfaces including vermin and pest
resistance.
 CORRIDOR- wide enough to facilitate the movement of
personnel as well as equipments and should be kept clean.
 UTILITIES- water lines, drain pipes and electrical
connection.
 ANIMAL ROOM DOORS- rust, vermin and dust proof. it
properly within their frames and provided with an
observation window.
 FLOORS- smooth, moisture proof, non-absorbent, skid-
proof, resistant to wear, acid, solvents, adverse effects of
detergents and disinfectants. Capable of supporting racks,
equipment and stored items without becoming gouged,
cracked, or pitted.
PHYSICAL FACILITIES
 DRAINS- floor drains are not essential in all rooms used
exclusively for housing rodents.
 WALLS & CEILINGS- free of cracks, unsealed utility
penetrations, or imperfect junction with doors, ceilings, floors
and corners.
 STORAGE AREAS- separate storage areas should be designed
for feed, bedding, cages and materials not in use.
 FACILITIES FOR SANITIZING EQUIPMET AND SUPPLIES-
an area for sanitizing cages and ancillary equipment is essential
with adequate water supply.
 EXPERIMENTAL AREA- should be carried out in a separate
area from the place where animals are housed.
ENVIRONMENT
TEMPERATURE AND HUMIDITY CONTROL-
 air conditioning .
 temperature with in the range of 64.4-84.0 F.
 relative humidity- 30-70% throughout the year.
 for large animal comfortable zone-18-37°˚c.
POWER & LIGHTING-
 he electrical system should be safe and provide appropriate
lighting and a sufficient no. of power outlets.
 A time control light system should be used.
NOISE CONTROL- noise free environment.
ANIMAL HUSBANDRY
CAGING & HOUSING SYSTEM-
Adequate ventilation .
Meet the biological need of animal Keep the animal
dry and clean.
Facilitate research while maintaining good health of
the animals.
Cages made of steel or painted steel.
Feeding and watering devices should be easily
accessible for filing, changing, cleaning and servicing.
FOOD
 Should be fed palatable, non-contaminated and
nutritionally adequate food.
 Feeders should allow easy access to food while avoiding
contamination by urine and faeces.
 Food should be available in a mounts sufficient to ensure
normal growth in immature animals and maintenance of
normal body weight, reproduction and lactations in adults.
 Areas in which diets are stored should be kept clean and
enclosed to prevent entry of insects or other animals.
 Diet should be free from heavy metals.
BEDDING
 Absorbent, free of toxic chemicals or other substances that
could injure animals or personnel, and of a type not readily
eaten by animals.
 Should be removed and replaced with fresh materials as
often as necessary to keep animal clean and dry.
 Should be- easily stored.
 Uncontaminated.
 Non-toxic.
 Non-malodorous.
 Disposable by incineration.
WATER
 Fresh.
 Potable .
 Uncontaminated.
WATER DISPOSAL
The most preferred method of waste disposal is incineration.
If wastes must be stored before removal , the waste storage
area should be separated from other storage facilities and
free of flies, cockroaches, rodents and other vermin.
PEST CONTROL
Programs designed to prevent, control, or eliminate the
presence of or infestations by pests are essential in an
animal environment.
EMERGENCY, WEEKEND AND HOLIDAY CARE
Animal should be cared for by qualified personnel every day,
including weekends and holidays, to safeguards their well-
being including emergency veterinary care.
RECORD KEEPING
 Animal house plans .
 Animal house staff record .
 Health record of staff/animals .
 All SOPs relevant to the animals .
 Breeding, stock, purchase and sales records.
 Minutes of institute animals ethics committee meetings.
 Records of experiments conducted with the no. of animals
used
 Death record .
 Clinical record of sick animals training record of staff
involved in animal activities .
 Water analysis report.
STANDARD OPERATING PROCEDURES (
SOPs)/ GUIDELINES
Maintain SOPs describing procedures/ methods adapted with
regard to animal husbandry, maintenance, breeding, animal
house microbial analysis and experimentation record.
SOPs should contain following items-
 Name of author .
 itle of SOP .
 Date of preparation.
 Reference of previous SOP on the same subject and date .
 Location and distribution of SOPs with sign of each recipient.
 Objectives
 Detailed information of the instruments used in relation with
animals .
 Normal value of all parameters.
TRANSPORT OF LABORATORY
ANIMALS
The main considerations for transport of animals are the
mode of transport, the containers, the animal density in
cages, food and water during transit, protection from
transit infection, injuries and stress.
ANAESTHESIA
 Sedatives, analgesics and anaesthetics should be used to
control pain or distress under experiment. Before use
actual anaesthetics the animals is prepared for anaesthesia
by over night fasting and using preanaesthetics,
 Local or general anaesthetics may be used depending on
type of surgical procedure.
DISPOSAL
 The transgenic and knockout animal should be first
enthanized and then disposed off as prescribed elsewhere
in the guidelines. A record of disposal and the manner of
disposal should be kept as a matter of routine.
Thank you

Cpcsea guidelines

  • 1.
    PREPARED BY-SUBODH SHAH PHARMACOLOGICALAND TOXICOLOGICAL SCREENING
  • 2.
    CPCSEA  Committee forthe Purpose of Control and Supervision of Experiments on Animals (CPCSEA).  Statutory body formed by the Act of the Indian Parliament under the Prevention of Cruelty to Animals Act, 1960 .  Formed in 1964 .  Revived in 1998, under the committed chairpersonship of Meneka Gandhi .  Head quarters at Chennai .  Includes various guidelines and sub committees.
  • 3.
    CPCSEA  National levelexpert committee to scrutinize and approve the research projects conducted using animals.  Introduced a national “Good Laboratory Practice” documen.  Introduced the credo of 3R principles.  2004 – CPCSEA officially accepts the concept of the 4th R. “investigators have a moral responsibility to take care of laboratory animals after use”.
  • 4.
    CPCSEA This committee iscomposed of  Members of the scientific community .  Regulatory authorities .  Animal activists.  The committee has 10 experts and 3 official members.
  • 5.
  • 6.
    CPCSEA and IAEC Roleof CPCSEA is to monitor animal experiments through ethics committees set up in institutions(IAEC). CPCSEA Nominee –important link between CPCSEA and IAEC. IAEC scrutinize all project proposals for experimentation onFor small animals.  give the final approve . For large animals- make its recommendation to SCLA (Sub-Committee on Large Animals) animals.
  • 7.
    IAEC composition --A BiologicalScientist. --Two Scientists from different bio disciplines. --A Veterinarian involved in care of Animals. --Scientist In-Charge of Animal House Facility. The Chairman (preferably Head of the Institution / Department) and Member Secretary need to be nominated from the above five members. Other members : Main Nominee, Link Nominee, Scientist from outside and Socially Aware Nominee nominated by CPCSEA. The validity of IAEC is for 3 years.
  • 8.
    CPCSEA goals:  To promotethe humane care of animals used in research.  To provide specifications that will enhance animals well being and quality of research. Objective: Effective functioning of Institutional animal ethical committee.
  • 9.
    Main Activities Registration ofestablishments .  for experiments on animals .  for Breeding of animals . Approval of Animal House Facilities . Permission of Committee for Conducting Experiments.
  • 10.
    CPCSEA guidelines Veterinary care: Provided by a veterinarian.  Daily observation of animals adopted Quarantine, Stabilization and Separation: Quarantine period for small lab animal  one wk to one mth- large lab animals : up to 6 weeks.  Physiologic, psychological and nutritional stabilization required .  Physical separation of animals by species to prevent anxiety and behavioral changes.
  • 11.
    Animal procurement and tranportation Procurementof animals done from established commercial animal vendors.  During transport, stress avoided by: Use of transport containers (cages or crates) of appropriate size .  Permissible number of animals accommodated in each container.
  • 12.
    Experimental area: Experiments shouldbe carried out in a separate area away from the place where they are housed. Separate functional areas for .  surgical support.  treatment of animals.  post operative and intensive care.
  • 13.
    PHYSICAL FACILITIES  BUILDINGMATERIALS- moisture-proof, fire-resistant, seamless materials are most desirable for interior surfaces including vermin and pest resistance.  CORRIDOR- wide enough to facilitate the movement of personnel as well as equipments and should be kept clean.  UTILITIES- water lines, drain pipes and electrical connection.  ANIMAL ROOM DOORS- rust, vermin and dust proof. it properly within their frames and provided with an observation window.  FLOORS- smooth, moisture proof, non-absorbent, skid- proof, resistant to wear, acid, solvents, adverse effects of detergents and disinfectants. Capable of supporting racks, equipment and stored items without becoming gouged, cracked, or pitted.
  • 14.
    PHYSICAL FACILITIES  DRAINS-floor drains are not essential in all rooms used exclusively for housing rodents.  WALLS & CEILINGS- free of cracks, unsealed utility penetrations, or imperfect junction with doors, ceilings, floors and corners.  STORAGE AREAS- separate storage areas should be designed for feed, bedding, cages and materials not in use.  FACILITIES FOR SANITIZING EQUIPMET AND SUPPLIES- an area for sanitizing cages and ancillary equipment is essential with adequate water supply.  EXPERIMENTAL AREA- should be carried out in a separate area from the place where animals are housed.
  • 15.
    ENVIRONMENT TEMPERATURE AND HUMIDITYCONTROL-  air conditioning .  temperature with in the range of 64.4-84.0 F.  relative humidity- 30-70% throughout the year.  for large animal comfortable zone-18-37°˚c. POWER & LIGHTING-  he electrical system should be safe and provide appropriate lighting and a sufficient no. of power outlets.  A time control light system should be used. NOISE CONTROL- noise free environment.
  • 16.
    ANIMAL HUSBANDRY CAGING &HOUSING SYSTEM- Adequate ventilation . Meet the biological need of animal Keep the animal dry and clean. Facilitate research while maintaining good health of the animals. Cages made of steel or painted steel. Feeding and watering devices should be easily accessible for filing, changing, cleaning and servicing.
  • 17.
    FOOD  Should befed palatable, non-contaminated and nutritionally adequate food.  Feeders should allow easy access to food while avoiding contamination by urine and faeces.  Food should be available in a mounts sufficient to ensure normal growth in immature animals and maintenance of normal body weight, reproduction and lactations in adults.  Areas in which diets are stored should be kept clean and enclosed to prevent entry of insects or other animals.  Diet should be free from heavy metals.
  • 18.
    BEDDING  Absorbent, freeof toxic chemicals or other substances that could injure animals or personnel, and of a type not readily eaten by animals.  Should be removed and replaced with fresh materials as often as necessary to keep animal clean and dry.  Should be- easily stored.  Uncontaminated.  Non-toxic.  Non-malodorous.  Disposable by incineration.
  • 19.
    WATER  Fresh.  Potable.  Uncontaminated. WATER DISPOSAL The most preferred method of waste disposal is incineration. If wastes must be stored before removal , the waste storage area should be separated from other storage facilities and free of flies, cockroaches, rodents and other vermin.
  • 20.
    PEST CONTROL Programs designedto prevent, control, or eliminate the presence of or infestations by pests are essential in an animal environment. EMERGENCY, WEEKEND AND HOLIDAY CARE Animal should be cared for by qualified personnel every day, including weekends and holidays, to safeguards their well- being including emergency veterinary care.
  • 21.
    RECORD KEEPING  Animalhouse plans .  Animal house staff record .  Health record of staff/animals .  All SOPs relevant to the animals .  Breeding, stock, purchase and sales records.  Minutes of institute animals ethics committee meetings.  Records of experiments conducted with the no. of animals used  Death record .  Clinical record of sick animals training record of staff involved in animal activities .  Water analysis report.
  • 22.
    STANDARD OPERATING PROCEDURES( SOPs)/ GUIDELINES Maintain SOPs describing procedures/ methods adapted with regard to animal husbandry, maintenance, breeding, animal house microbial analysis and experimentation record. SOPs should contain following items-  Name of author .  itle of SOP .  Date of preparation.  Reference of previous SOP on the same subject and date .  Location and distribution of SOPs with sign of each recipient.  Objectives  Detailed information of the instruments used in relation with animals .  Normal value of all parameters.
  • 23.
    TRANSPORT OF LABORATORY ANIMALS Themain considerations for transport of animals are the mode of transport, the containers, the animal density in cages, food and water during transit, protection from transit infection, injuries and stress.
  • 24.
    ANAESTHESIA  Sedatives, analgesicsand anaesthetics should be used to control pain or distress under experiment. Before use actual anaesthetics the animals is prepared for anaesthesia by over night fasting and using preanaesthetics,  Local or general anaesthetics may be used depending on type of surgical procedure.
  • 25.
    DISPOSAL  The transgenicand knockout animal should be first enthanized and then disposed off as prescribed elsewhere in the guidelines. A record of disposal and the manner of disposal should be kept as a matter of routine.
  • 26.