Cpcsea ppt

CPCSEA Guidelines
A Seminar presented as a part of
I Year M. Pharm I semester Requirement
ACY 2019 – 20
By
M. Kavya Nainita
Regd. No. 19L81S0406
Pharmaceutical Quality Assurance,
Raghavendra Institute of Pharmaceutical
Education & Research (AUTONOMOUS),
Anantapuramu.
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CONTENTS
• CPCSEA - Definition
• Goals
• Objective
• Committee members
• Forms
• CPCSEA Annexures
• Animal procurement
• References
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PHARMACEUTICAL QUALITY ASSURANCE
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Introduction
• Committee for the Purpose of Control and
Supervision of Experiments on Animals.
• It is statutory committee.
• Established under Section 15 of the prevention
of cruelty to animals act 1960.
• Committee was reconstituted on 17 February,
2016.
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CPCSEA
Definition
Committee for the purpose of control and
supervision of experiments on animals.
• It is statutory body formed by the act of the Indian
Parliament under the Prevention of Cruelty to
Animals Act, 1960.
• The secretariat of CPCSEA has published its
guidelines, to ensure humane and ethical treatment of
animals, while carrying out legitimate scientific
research.
• It was formed in 1964.
• Headquarters is at Ballabhgarh of Faridabad district
in Haryana.
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GOAL
• To promote the humane care of animals used in
research.
• To provide specifications that will enhance animals
well being and quality of research.
• Effective functioning of IAEC.
• To provide guideline for:
Housing, care, breeding and maintenance.
Source of experimental animals
Acceptable experimental procedures for
anaesthesia and euthanasia.
OBJECTIVE
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COMMITTEE MEMBERS
• It is composed of
Members of the scientific
community
Regulatory authorities
Animal activists
The committee has 20 Experts
and 3 Official Members.
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1 Special Secretary / Additional Secretary, In-
charge of Animal Welfare, Government of
India, Ministry of Environment, Forest &
Climate Change, New Delhi
Chairman
2 Joint Secretary (Animal Welfare), Ministry
of Environment, Forest & Climate Change,
New Delhi
Vice Chairman
3 Representative from Drug Controller
General of India (DCGI), New Delhi
Member
4 Representative from Medical Council of
India (MCI), New Delhi
Member
5 Representative from Veterinary Council of
India (VCI), New Delhi
Member
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6 Representative from Pharmacy
Council of India (PCI), New Delhi
Member
7 Representative from University Grants
Commission (UGC), New Delhi
Member
8 Representative from Animal Welfare
Board of India (AWBI), Ballabhgarh
Member
9 Dr. Suresh Pothani, Representative
ICMR, Director In Charge & Scientist
“G” ICMR – National Animal
Resource Facility for Biomedical
Research, Hyderabad
Member
10 Prof. Asmita Gajbhiye, Professor &
Head, Dept of Pharmaceutical
Sciences, Dr. H.S. Gour
Vishwavidyalaya, Sagar
Member
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11 Prof. Alok Dhawan, Director, CSIR –
Indian Institute of Toxicology
Research, Lucknow
Member
12 Dr. Anurag Agrawal, Director, CSIR
– Institute of Genomics & Integrative
Biology, New Delhi
Member
13 Dr. Ram Vishwakarma, Director,
CSIR – Indian Institute of Integrative
Medicine, Jammu
Member
14 Dr. Pardeep Kumar Yadav, Senior
Veterinary Officer, All India Institute
of Medical Science, New Delhi
Member
15 Dr. S.G. Ramachandra, Chief
Research Scientist, Central Animal
Facility, Indian Institute of Science,
Bangalore
Member
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16 Dr. Subeer S. Majumdar, Director,
National Institute of Animal
Biotechnology, Hyderabad
Member
17 Prof. Dr. M. Ramachandra Mohan,
Professor, Dept of Zoology, Bangalore
University
Member
18 Prof. Madan Mohan Chaturvedi,
Professor and Head, Department of
Zoology, University of Delhi, New Delhi
Member
19 Prof. Aditya Kumar, Director, SKS
Institute, Mathura
Member
20 Director/Deputy Secretary (Animal
Welfare) Ministry of Environment,
Forests & Climate Change, New Delhi.
Member
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Forms
Forms Purpose
FORM A [As per rule 5(a)] Application for Registration
with CPCSEA
Form B (per rule 8(a) Submission of Research
Protocol (s) on Large Animals
Form C Record of Animals bred /
acquired
Form D Record of Animals Acquired
and Experiments performed
FORM- E Record of animals sold
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IAEC
• Institutional animal ethical committee.
Definition:
• Body comprising of a group of persons
recognized and registered by the CPCSA.
Function:
• Review and approve all types of protocols for
research involving animal experimentation.
• Obtain the periodic reports on research
development and shall ensure visit to animal
house facility and laboratory.
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Ministry of
Environment
and Forests
(Animal
Welfare)
CPCSEA
IAEC IBSC/IBC
Institutional Bio Safety Committee
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• Role of CPCSEA is to monitor animal.
Experiments through ethics committees set up
in institutions (IAEC).
• IAEC scrutinize all project proposals for
experimentation on animals.
For small animals- give the final
approval
For large animals-make its
recommendation to SCL
(Sub-Committee on Large
Animals)
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Qualification
• B. V. Sc
• M.Sc. (Zoology/ Animal Sciences/ Animal
Biotechnology)
• M.Sc. / MTech (Life Sciences, Biological
Sciences/ Biochemistry/ Biotechnology/
Biomedical Engineering) with experience in
animal handling and animal research.
• M. Pharm with experience in animal handling
and animal research.
• MD/ MS with research experience in laboratory
animal handling.
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• Age limit: 65 years.
• Duration: 5 years.
• Inspection report of animal house with
photographs by IAEC members is required to
be sent once in a calendar year.
• If action is required, the facility must provide
within 30 days.
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Veterinary care
•Adequate veterinary care must be provided and
is the responsibility of a veterinarian or a person
who has training or experience in laboratory
animal sciences and medicine.
•Observed regularly for sign of illness, injury or
abnormal behaviour.
•Contagious disease – isolated from healthy
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Surveillance, Diagnosis, Treatment
and Control of disease
(Annexure 1 and 2)
• All animals should be observed for signs of
illness, injury or abnormal behaviour by
animal house staff.
• Unexpected deaths and signs of illness,
distress or other deviations from normal health
conditions in animals.
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Physical Relationship of Animal
Facilities to Laboratories
(Annexure-3)
• Separation of animal facilities from personnel
areas such as offices, conference rooms, and
other laboratories.
• Located away from dust, smoke, noise, wild
rodents, insects and birds.
• Animal rooms should occupy 50-60% of
constructed area.
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Transport of laboratory animals (Annexure – 4)
Mouse Rat Hamster Guinea
pig
Rabbit Cat Dog Monkey
Max.no
Of
animals/
cage
25 25 25 12 2 1 or 2 1 or 2 1
Material
used in
transport
box
Metal
cardboard,
synthetic
material
metal metal Bamboo/
wood/metal
Space/
animal
(cm²)
Minimum
height of
box (cm)
20-25
12
80-
100
14
80-100
12
160-180
15
1000-
1200
30
1400-
1500
40
3000
50
2000-4000
48
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Anaesthesia
(Annexure-5)
• Sedatives, analgesics, anaesthetics should be used to
control pain or distress under experiment.
• Before using anaesthetics the animal is prepared for
anaesthesia by overnight fasting and using pre-
anaesthetics (scopolamine, atropine, diazepam, etc.)
• The animal should remain under veterinary care till it
completely recovers from anaesthesia and
postoperative stress.
Narcosis
Relaxation Analgesia18-04-2020 22
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Euthanasia
(Annexure-6)
• Death without causing anxiety, pain or distress
with minimum time lag phase.
• Done when an animal required to be sacrificed
or termination of an experiment or otherwise
for ethical reasons.
• Tranquilizers have to be administered to larger
species such as monkeys, dogs and cats before
an euthanasia procedure.
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Animal care and Technical
Personnel
(Annexure-7)
• Animal care programs
• On-the-job training
• Trained person in laboratory animal science.
• Protective clothing (face masks, head covers,
aprons, gloves, gumboots, other footwear, etc.)
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Animal Experimentation Involving
Hazardous Agents
(Annexure-8)
• Policies governing experimentation with
hazardous agents.
• Examine the proposal on animal experiments
involving hazardous agents.
• IBSC members are knowledgeable about
hazardous agents are in place in most of the
higher-level education, research institutes and in
many pharmaceutical industries for taking care of
safety issues.
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Animal procurement
• All animals must be acquired lawfully as per
the CPCSEA guidelines.
• A health surveillance program for screening
incoming animals should be carried out to
assess animal quality.
• Each consignment of animals should be
inspected for compliance with procurement
specifications.
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Quarantine
Definition:
• Separation of newly received animals until the
health and possibly the microbial status of
newly received animal have been determine.
• An effective quarantine minimizes the chance
for introduction of pathogens into an
established colony.
• Quarantine period :
 small lab animals- 1 week to 1 month.
 large lab animal – 6weeks.
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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
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Stabilization and Separation
• Physiologic, psychological and nutritional
stabilization should be given before their use.
• Separation is needed to prevent interspecies
diseases transmission and to eliminate anxiety
and possible physiological and behavioural
changes due to interspecies conflict.
• To prevent anxiety and behavioural changes.
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Physical facilities
Building materials Durable, moisture – proof, fire
resistant and pest resistant.
corridors Movement of personnel and equipment
Animal room doors Fit properly, no rust
Exterior windows Not recommended
floors Smooth, moisture proof, non absorbent,
skid proof floors
drains Proper drainage, floors should be sloped
Storage areas For feed, bedding, cages
Temperature and humidity Between 18-29 °C and 30-70 %
ventilation Designed with 12-15 air cycles / hour
Power and lighting Fluorescent lights
noise control Noise free environment
Concrete walls are more effective.
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Animal husbandry
Housing system:
Freedom of movement, normal
postural adjustments.
Comfortable environment
Easy access to food and water
Adequate ventilation
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Food and water
Feed should contain Feed should not contain
Moisture Insecticides, hormones, antibiotics,
fumigants or toxicants
Crude fibre, protein, fat Heavy metals
Essential bits, minerals, carbohydrates
•Palatable
•Non-contaminated
•Nutritionally adequate
•Fresh
•Uncontaminated drinking water
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Bedding
• Adsorbent, free from toxic chemicals.
• Should be removed and replaced periodically
with fresh materials.
• Ideal to change the bedding twice in a week.
• Newly delivered pups should be provided
wherever needed. (paper, cotton, etc.)
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Transgenic animals
• Transgenic animals are those animals, into
whose germs line foreign genes have been
engineered.
Used for study of biological functions of
specific genes.
• Knockout animals are those specific genes
have been disrupted leading to loss of function.
Maintained in clean room environment or in
animal isolators.
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Waste disposal
• Removed regularly and frequently.
• Disposed in a safe and sanitary manner.
• Preferred method – Incineration (thermal
treatment – waste materials converts waste into
ash, flue gas and heat).
• Waste cans containing animal tissue, carcasses
and hazardous wastes – leak proof.
• Cold storage might be necessary to prevent
decomposition of biological wastes.
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Emergency, Weekend And Holiday
Care
• If any emergency, institutional security
personnel and fire or police officials should be
able to reach responsible persons for the
animals.
• Emergency veterinary care.
• Posting emergency procedures, names, or
telephone numbers in animals facilities in
security department.
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Multiple surgical procedures on
single animal
• No animal should be used for experimentation
for more than 3 years unless adequate
justification is provided.
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Breeding and Genetics
• The breeding stock must be procured from
CPCSEA registered breeders or suppliers
ensuring that genetic makeup and health status
of animal is known.
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Record keeping
• Staff record- both technical and non-technical.
• Health record of staff animals.
• All SOP’s relevant to the animals.
• Breeding, stock, purchase and sales records.
• Records of experiments conducted with the
number of animals used.
• Death record
• Clinical record of sick animals.
• Training record of sick animals
• Training record of staff involved.
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Standard operating procedures
• Name of author
• Title of sop
• Date of preparation
• Reference of previous SOP
• Objectives
• Detailed information of instruments used in
animal methodology.(Model no., Serial no.)
• Normal value of all parameters
• Hazard identification and risk assessment.
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References
• CPCSEA.nic.in
• Appendix I of the New Zealand “Good Practice
Guide for the Use of Animals in Research, Testing
and Teaching” entitled “Pain: Some Concepts and
Definitions”.
• Derelanko MJ. The toxicologist's pocket
handbook. CRC Press; 2017 Nov 6.
• Olfert ED, Cross BM, McWilliam AA, editors.
Guide to the care and use of experimental
animals. Ottawa: Canadian Council on Animal
Care; 1993.
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I'm so proud !
All of my kids
are going into
research.
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