SOP for Handling Laboratory Animals in Preclinical Studies

Standard Operating Procedure (SOP) for Handling Laboratory Animals in Preclinical Studies

1) Purpose

The purpose of this Standard Operating Procedure (SOP) is to define the proper handling, care, and ethical treatment of laboratory animals used in preclinical studies. The SOP ensures that animals are handled in a humane, safe, and scientifically appropriate manner during all stages of the study, from transport and housing to experimental procedures. This SOP supports the maintenance of animal welfare and compliance with ethical guidelines and regulatory requirements.

2) Scope

This SOP applies to all personnel involved in the handling and care of laboratory animals in preclinical studies. It covers procedures for animal acquisition, transport, housing, handling during experimental procedures, and euthanasia, in compliance with ethical guidelines and regulatory standards. The SOP is relevant to animal care technicians, researchers, study directors, and veterinarians involved in preclinical research.

3) Responsibilities

Study Directors: Responsible for overseeing the handling and care of animals in accordance with the study protocol, ensuring adherence to ethical and regulatory standards.
Animal Care Technicians: Responsible for the daily handling, care, and monitoring of animals, including feeding, cleaning, and ensuring animals’ comfort and welfare.
Veterinary Staff: Responsible for monitoring animal health, providing medical care, and ensuring

the humane treatment of animals during procedures.

Regulatory Affairs: Ensures compliance with relevant regulatory guidelines, such as those from IACUC, GLP, and animal welfare standards.

Quality Assurance (QA): Ensures that animal handling procedures are compliant with internal SOPs and external regulatory requirements, and conducts audits as necessary.

4) Procedure

The following steps outline the procedure for handling laboratory animals during preclinical studies:

Step 1: Animal Acquisition and Transport
1. Ensure that animals are acquired from accredited and ethical suppliers, with documentation of origin, health status, and any vaccinations.
2. Upon arrival, conduct an initial health check and document the animal’s physical condition, including any signs of stress or illness.
3. Transport animals within the facility in a humane and safe manner, ensuring that appropriate cages or transport containers are used to minimize stress.
Step 2: Animal Housing
1. House animals in appropriate environments according to their species-specific needs, including the correct cage size, bedding, food, and water.
2. Ensure that the housing environment meets regulatory standards for temperature, humidity, light cycles, and ventilation.
3. Monitor housing conditions regularly and adjust as needed to ensure the animals’ well-being.
Step 3: Animal Handling During Procedures
1. Handle animals with care to minimize stress. Use gentle restraint techniques appropriate for the species.
2. For procedures requiring anesthesia or sedation, ensure that animals are monitored closely throughout the procedure to ensure their safety and comfort.
3. Follow all study protocols for administering treatments, collecting samples, or conducting experiments, ensuring that no unnecessary harm or distress is caused to the animals.
Step 4: Monitoring and Health Checks
1. Monitor animals for signs of distress, illness, or abnormal behavior, and take action as needed, including notifying veterinary staff for medical intervention.
2. Perform regular health checks and document any findings, including weight loss, changes in behavior, or injury.
3. Provide veterinary care as needed, and ensure that animals receive appropriate medications or treatments.
Step 5: Euthanasia
1. Ensure that euthanasia is conducted humanely, using approved methods such as CO2 asphyxiation, cervical dislocation, or anesthetic overdose, depending on the species and protocol requirements.
2. Follow ethical guidelines for euthanasia, ensuring that it is done at the appropriate time based on the animal’s condition or study endpoint.
3. Document the euthanasia procedure, including the method used and the time of death.
Step 6: Record Keeping
1. Maintain accurate records of animal handling activities, including acquisition, transport, health checks, and experimental procedures.
2. Ensure that all records are securely stored and are readily available for regulatory audits or inspections.

5) Documents

The following documents should be maintained during the handling of laboratory animals:

Animal Acquisition and Transport Logs
Animal Health Monitoring Records
Animal Care and Housing Logs
Procedure and Treatment Records
Euthanasia Logs
Protocol Deviations and Incident 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 (GLP)
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 Handling Procedure Template

Step	Procedure	Responsible Person	Documentation Required
Animal Acquisition	Acquire animals from accredited suppliers and conduct initial health check.	Study Director, Veterinary Staff	Animal Acquisition Log
Animal Housing	House animals in species-appropriate conditions with required resources.	Animal Care Technicians	Animal Housing Log
Handling During Procedures	Use proper restraint techniques and follow protocol for treatments or experiments.	Animal Care Technicians, Researchers	Procedure Record, Health Check Logs
Euthanasia	Perform humane euthanasia according to approved guidelines.	Veterinary Staff	Euthanasia Log