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Research Methodology (M. Pharm, IIIrd Sem.)_UNIT_IV_CPCSEA Guidelines for Laboratory animal facility.pptx

RAHUL PAL
RAHUL PAL

CPCSEA guidelines for laboratory animal facility: Goals, veterinary care, quarantine, surveillance, diagnosis, treatment and control of disease, personal hygiene, location of animal facilities to laboratories, anesthesia, euthanasia, physical facilities, environment, animal husbandry, record keeping, SOPs, personnel and training, transport of lab animals.

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UNIT: IV
CPCSEA Guidelines for
Laboratory animal facility
Presented & Written By: *Rahul Pal, Prachi Pandey
M. Pharm (Pharmaceutics).
*Department of Pharmaceutics, NIMS Institute of Pharmacy, NIMS University, Jaipur,
Rajasthan, 303121, India.
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*RahulPal, Prachi Pandey
Master’sof Pharmacy(M. Pharm)
“Pharmaceutics”
“COVERED SYLLABUS”
“CPCSEA guidelines for laboratory animal
facility”: Goals, veterinary care, quarantine,
surveillance, diagnosis, treatment and control of
disease, personal hygiene, location of animal
facilities to laboratories, anesthesia, euthanasia,
physical facilities, environment, animal
husbandry, record keeping, SOPs, personnel and
training, transport of lab animals.
INTRODUCTION
 “CPCSEA” stands for, The Committee for the Purpose of Control
and Supervision of Experiments on Animals.
 It was originally established in 1964, under 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.
GOALS
› The CPCSEA's primary goal is to promote the humane treatment of
animals used in research, education, and testing.
› Minimizing animal suffering.
› Ensuring scientific validity and quality.
› Fostering transparency and accountability.
› Building a collaborative environment.
VETERINARY CARE
Veterinary care plays a crucial role in upholding the CPCSEA's goal.
The committee emphasizes several key aspects of veterinary care:
› Qualified supervision.
› Preventive measures.
› Humane procedures: Pain management and Euthanasia.
› Recordkeeping.
› Collaboration with researchers.
Veterinary care is an integral part of the CPCSEA's framework for
ensuring animal welfare in research.
QUARANTINE
It involves the isolation of newly acquired animals from the existing
animal population for a specific period. This serves several important
purposes:
1. Disease prevention: Unknown pathogens.
2. Acclimatization and stabilization: New environments can be
stressful for animals, Stabilizes physiological and psychological
factors.
3. Minimizing cross-contamination.
By implementing quarantine protocols, the committee able to create a
responsible and sustainable environment for animal research.

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Research Methodology (M. Pharm, IIIrd Sem.)_UNIT_IV_CPCSEA Guidelines for Laboratory animal facility.pptx

  • 1. UNIT: IV CPCSEA Guidelines for Laboratory animal facility Presented & Written By: *Rahul Pal, Prachi Pandey M. Pharm (Pharmaceutics). *Department of Pharmaceutics, NIMS Institute of Pharmacy, NIMS University, Jaipur, Rajasthan, 303121, India. B I O S T A T I S T I C S *RahulPal, Prachi Pandey Master’sof Pharmacy(M. Pharm) “Pharmaceutics”
  • 2. “COVERED SYLLABUS” “CPCSEA guidelines for laboratory animal facility”: Goals, veterinary care, quarantine, surveillance, diagnosis, treatment and control of disease, personal hygiene, location of animal facilities to laboratories, anesthesia, euthanasia, physical facilities, environment, animal husbandry, record keeping, SOPs, personnel and training, transport of lab animals.
  • 3. INTRODUCTION  “CPCSEA” stands for, The Committee for the Purpose of Control and Supervision of Experiments on Animals.  It was originally established in 1964, under 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.
  • 4. GOALS › The CPCSEA's primary goal is to promote the humane treatment of animals used in research, education, and testing. › Minimizing animal suffering. › Ensuring scientific validity and quality. › Fostering transparency and accountability. › Building a collaborative environment.
  • 5. VETERINARY CARE Veterinary care plays a crucial role in upholding the CPCSEA's goal. The committee emphasizes several key aspects of veterinary care: › Qualified supervision. › Preventive measures. › Humane procedures: Pain management and Euthanasia. › Recordkeeping. › Collaboration with researchers. Veterinary care is an integral part of the CPCSEA's framework for ensuring animal welfare in research.
  • 6. QUARANTINE It involves the isolation of newly acquired animals from the existing animal population for a specific period. This serves several important purposes: 1. Disease prevention: Unknown pathogens. 2. Acclimatization and stabilization: New environments can be stressful for animals, Stabilizes physiological and psychological factors. 3. Minimizing cross-contamination. By implementing quarantine protocols, the committee able to create a responsible and sustainable environment for animal research.
  • 7. SURVEILLANCE Surveillance plays a pivotal role in the CPCSEA's mission to ensure animal welfare and uphold ethical research practices. It involves the systematic observation and monitoring of animals. To identify any potential health problems, distress, or deviations from expected behavior. The several key aspects of surveillance under CPCSEA include: › Daily observations. › Environmental monitoring. › Body weight and condition scoring. › Behavioral observations. › Recordkeeping and data analysis.
  • 8. DIAGNOSIS Diagnosis plays a crucial role in ensuring animal welfare and upholding ethical research practices. It involves identifying the cause of an animal's illness or distress. The several aspects of diagnosis under CPCSEA include:  Clinical examination.  Diagnostic tests: Blood tests, imaging techniques like X-rays or ultrasound.  Differential diagnosis.  Consulting specialists.  Animal welfare considerations.  Documenting the diagnosis. By promoting effective diagnostic practices, the CPCSEA strives to ensure that animals used in research receive timely and accurate medical attention.
  • 9. TREATMENT AND CONTROL OF DISEASE CPCSEA extends to the effective treatment and control of diseases within animal facilities. The various steps how CPCSEA guidelines address this crucial aspect: 1. Proactive Disease Prevention. 2. Prompt Diagnosis and Treatment. 3. Hygiene and Sanitation. 4. Recordkeeping and Reporting. 5. Collaboration and Training: Veterinarians/researchers, Training of animal caring staff.
  • 10. CONT… PROACTIVE DISEASE PREVENTION › Vaccination › Parasite control › Nutritional management › Environmental enrichment PROMPT DIAGNOSIS AND TREATMENT › Daily monitoring › Qualified veterinary care › Appropriate medication › Pain management › Isolation and quarantine
  • 11. PERSONAL HYGIENE Maintaining high standards of personal hygiene is an essential aspect of animal welfare under the CPCSEA. This not only protects the animals from potential infections but also ensures the validity of research data. The various aspects for personal hygiene as followings: › Clean clothing, footwear and Hand hygiene. › Jewellery and accessories. › Eating, drinking, smoking, hair and beard. › Protective equipment, Training and awareness. › Facilities and supplies. The CPCSEA aims to foster a culture of personal hygiene within animal research facilities.
  • 12. LOCATION OF ANIMAL FACILITIES TO LABORATORIES The CPCSEA lays down specific guidelines for the location of animal facilities relative to laboratories. This aims to minimize stress, noise, and other disturbances for the animals while ensuring research integrity and practicality. The various key requirements: 1) Physical Separation: Separate building, wing, floor, or room, Distance from disturbance. 2) Dedicated Access: Separate pathways, entrances and controlled access points. 3) Environmental Considerations: Natural light, ventilation, Temperature, humidity control and noise reduction. 4) Additional Guidelines: Waste disposal, Security and emergency preparedness.
  • 13. ANESTHESIA Anesthesia plays a crucial role in achieving goal by ensuring animals are pain-free and unconscious during painful procedures or surgeries. The CPCSEA lays down specific guidelines for the use of anesthesia in animals: › Justification and minimization. › Qualified personnel. › Pre-anesthetic assessment, Appropriate anesthetic agents and dosages. › Pain management: An integral part of anesthesia. › Monitoring and recordkeeping. › Recovery and post-operative care. › Training and education.
  • 14. CONT… Anesthesia is a controlled, temporary state of unconsciousness, painlessness, and muscle relaxation induced in animals through medication. The different types of anesthesia can be used in animals, including: a) General anesthesia: This induces complete unconsciousness and muscle relaxation, often through inhaled gases or injectable medications. b) Local anesthesia: This numbs a specific area of the body, allowing for procedures on that area while the animal remains conscious. c) Regional anesthesia: This numbs a larger area of the body, such as a limb, while the animal remains conscious or lightly sedated.
  • 15. Species: Rodent (rat or mouse) Procedure: Tissue collection Agent: Ketamine/xylazine combination (injectable) Dosage: Ketamine 80-100 mg/kg, xylazine 5-10 mg/kg, both given intraperitoneally Species: Rabbit Procedure: Dental cleaning Agent: Propofol (injectable) Dosage: 5-10 mg/kg intravenous bolus, followed by a maintenance infusion of 1-5 mg/kg/hr Species: Cat Procedure: Ovariohysterectomy (spaying) Agent: Ketamine (injectable) and medetomidine (injectable) Dosage: Ketamine 5-10 mg/kg, medetomidine 0.05-0.1 mg/kg, both given intramuscularly Species: Horse Procedure: Colic surgery Agent: Sevoflurane (inhaled gas) and epidural analgesia (local anesthetic) Dosage: Sevoflurane 1-3% in oxygen, epidural bupivacaine 0.5- 1.0 ml/segment Species: Dog Procedure: Neutering Agent: Isoflurane (inhaled gas) Dosage: 1-3% isoflurane in oxygen, adjusted based on individual response SPECIFIED E X A M P L E S
  • 16. EUTHANASIA Euthanasia refers to the intentional act of ending an animal's life to relieve suffering or prevent further pain. Purpose: The euthanasia having several purposes as followings: › Painless death. › Relief from suffering. › Population control. Euthanasia is a sensitive and ethical decision. Methods: Various methods can be employed for euthanasia. These are like: Overdose of anesthetic agents, Cervical dislocation, Carbon dioxide (CO2) inhalation and barbiturate injection or electrocution.
  • 17. PHYSICAL FACILITIES CPCSEA to ensure the animals' physical and mental well-being, minimizing stress and promoting their health and comfort. The various key aspects of physical facilities for animals under CPCSEA: › Caging and housing. › Environmental sanitation and hygiene. › Food and water: Nutritious diet, Fresh water. › Veterinary care. › Recordkeeping. Animal facilities can create a safe, comfortable, and stimulating environment for animals used in research.
  • 18. ENVIRONMENT CPCSEA recognizes the importance of a stimulating and stress-free environment for animals used in research. The key aspects of environment for animals under CPCSEA: 1. Sensory stimulation. 2. Social interaction. 3. Choice and control. 4. Species-specific considerations. 5. Regular monitoring and evaluation. These guidelines for environmental enrichment to promote the animals' physical and mental well-being.
  • 19. ANIMAL HUSBANDRY Animal husbandry practices for animals used in research fall under the strict guidelines of the CPCSEA. These guidelines aim to ensure ethical treatment, good welfare, and minimal suffering for animals throughout their involvement in research. How animal husbandry practices are addressed under CPCSEA: › Housing and environment: Species-specific, temp. Humidity and Lighting cycles › Food and water › Hygiene and sanitation › Veterinary care and record keeping.
  • 20. RECORD KEEPING The Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) places great emphasis on meticulous record keeping throughout all stages of animal research. › Detailed records: Maintain detailed records of all animal care procedures, including housing conditions, diet, veterinary care, observations, and any abnormalities. This ensures proper monitoring and animal well-being. › Animal identification: Each animal should have proper identification tags or other methods to track individual health and well-being.
  • 21. SOPs CPCSEA emphasizes the importance of standardized procedures to ensure the ethical treatment and welfare of animals in research. These SOPs cover various aspects of animal care and use, from housing and husbandry to experimental procedures and recordkeeping. The key areas where SOPs are crucial under CPCSEA guidelines: › Animal Acquisition and Housing › Institutional Animal Ethics Committee (IAEC). › Animal Housing and Husbandry. › Animal Experimentation: For drugs, emergency protocols etc. › Recordkeeping and Documentation. SOPs are not static documents. They should be regularly reviewed, updated, and adapted based on new scientific knowledge, changes in animal welfare best practices, and evolving regulatory requirements.
  • 22. CONT… › SOPs stands for Standard Operating Procedures. These are detailed, step-by-step instructions that outline how specific tasks related to animal care and use should be carried out. › They are essential for ensuring the consistent, ethical, and humane treatment of animals throughout their involvement in research.
  • 23. PERSONNELAND TRAINING The CPCSEA recognizes the crucial role of qualified and well-trained personnel in ensuring the ethical treatment and well-being of animals used in research. These individuals are responsible for various aspects of animal care, from husbandry and handling to experimental procedures and recordkeeping. › Qualifications and experience: Animal care personnel, Researchers and technicians and Veterinarians. › Training requirements: Regular refresher training and Specialized Training. › Training content and delivery. Qualified and well-trained personnel are not just an expense but an investment in ethical research and animal welfare.
  • 24. TRANSPORT OF LAB ANIMALS The transport of laboratory animals brings unique challenges and ethical considerations. Ensuring their safety, comfort, and well-being during transportation is crucial. CPCSEA outlines specific guidelines to ensure responsible and humane practices in this process. The various key aspects to consider for the transport of lab animals under CPCSEA:  Planning and preparation.  Transportation containers and environment.  Animal handling and care.  Post-transport care.  Adherence to regulations. Responsible transport of lab animals requires careful planning, adherence to ethical principles, and prioritizing animal welfare throughout the process.
  • 25. REFERECES 1. Committee for the Purpose of Control and Supervision on Experiments on Animals. (2003). CPCSEA Guidelines for laboratory animal facility. Indian J Pharmacol, 35(4), 257-274. 2. Mahesh, N. M. IMPACT OF ‘CPCSEA’GUIDELINES ON LABORATORY ANIMALS USE. 3. Pereira, S., Veeraraghavan, P., Ghosh, S., & Gandhi, M. (2004). Animal experimentation and ethics in India: the CPCSEA makes a difference. Alternatives to laboratory animals, 32(1_suppl), 411-415. 4. Qadri, S. S., & Ramachandra, S. G. (2018). Laws, regulations, and guidelines governing research animal care and use in India. In Laboratory animals (pp. 237-261). Academic Press.