4) Procedure

The following steps outline the procedure for managing animal facilities for preclinical studies:

1. Step 1: Facility Design and Setup
   1. Ensure that the animal facility is designed to meet regulatory requirements and provide a safe and comfortable environment for animals.
   2. Include specific areas for animal housing, medical care, surgery, waste disposal, and staff duties.
   3. Ensure that the facility is equipped with necessary systems such as ventilation, temperature and humidity control, lighting, and backup power supplies to maintain optimal conditions for animal housing.
2. Step 2: Animal Housing
   1. Provide appropriate housing for animals according to species requirements, including cages, bedding, food, and water, and enrichment devices to support natural behaviors.
   2. Monitor and maintain the housing environment to ensure it meets temperature, humidity, and ventilation requirements.
   3. Ensure proper hygiene by establishing protocols for cage cleaning and waste disposal, and follow a routine schedule for food and water replenishment.
3. Step 3: Environmental Controls and Monitoring
   1. Monitor environmental factors such as temperature, humidity, and air quality to maintain optimal conditions for animal care.
   2. Ensure that all equipment, including ventilation systems, temperature and humidity controllers, and lighting systems, is functioning properly and is maintained regularly.
   3. Implement contingency measures, including backup power systems, in case of equipment failure or environmental deviations.
4. Step 4: Staff Training and Competency
   1. Provide comprehensive training to all personnel involved in animal care and facility management, including ethical standards, animal handling techniques, and safety protocols.
   2. Ensure that all personnel are certified and proficient in species-specific care and handling procedures, and update their training regularly as required by new regulations or procedures.
5. Step 5: Animal Welfare and Monitoring
   1. Regularly monitor the health and well-being of all animals in the facility, including assessing their physical condition, behavior, and any signs of illness or distress.
   2. Provide veterinary care for any sick or injured animals and ensure that humane euthanasia protocols are followed when necessary.
   3. Document and report any health issues, injuries, or abnormal behaviors immediately to the veterinary staff.
6. Step 6: Record Keeping and Documentation
   1. Maintain accurate and up-to-date records of animal care, including health monitoring, medication administration, and any incidents or treatments provided.
   2. Ensure that all records are properly stored and accessible for audits, inspections, and regulatory compliance checks.
7. Step 7: Regulatory Compliance and Audits
   1. Ensure that the animal facility operates in compliance with local, national, and international animal welfare laws and regulations, including the IACUC protocols.
   2. Conduct regular internal audits of facility operations to ensure adherence to Good Laboratory Practice (GLP), SOPs, and regulatory requirements.
   3. Address and rectify any non-compliance or deficiencies identified during audits promptly.

5) Documents

The following documents should be maintained throughout the operation of the animal facility:

1. Animal Housing Logs
2. Environmental Monitoring Reports
3. Staff Training Records
4. Health and Welfare Monitoring Logs
5. Facility Maintenance and Inspection Logs
6. Audit and Compliance Reports

6) Abbreviations

• IACUC: Institutional Animal Care and Use Committee
• GLP: Good Laboratory Practices
• QA: Quality Assurance
• FDA: Food and Drug Administration
• EMA: European Medicines Agency

7) References

References to regulatory guidelines and scientific literature that support this SOP:

• OECD Principles of Good Laboratory Practice
• FDA Guidelines for Animal Care in Research
• ICH Guidelines for Nonclinical Safety Testing

8) Version

Version 1.0: Initial version of the SOP.

9) Annexure

Animal Facility Management Checklist