Understanding SOPs and GLPs in Animal Research Facilities

What are Standard Operating Procedures (SOPs)?

Written instructions approved by management used to perform routine activities.

What do Institutional SOPs describe?

Basic husbandry and housekeeping chores in animal rooms, such as food rotation and equipment checks.

What is the purpose of Procedural SOPs?

To provide specific instructions for each study, such as breeding checks or blood collection protocols.

What are Good Laboratory Practices (GLPs)?

A group of regulations for animal and nonanimal research and safety studies funded or reviewed by the FDA and EPA.

What is the main purpose of GLPs?

To validate and document safety test processes so they can be reconstructed if needed.

Which agency's GLP regulations apply to studies determining the safety of test materials?

The FDA.

What types of studies fall under FDA GLP regulations?

Studies involving human or veterinary drug testing, food coloring additives, medical devices, or biologics.

What does the EPA's GLP regulations apply to?

Experiments on test materials that are pesticides or toxic substances.

What is one requirement for an animal facility to meet GLP standards?

Adequately train personnel and maintain a current training file for each individual.

What is the role of the Quality Assurance (QA) unit in GLP compliance?

To independently monitor all phases of the research process to ensure compliance with GLPs, SOPs, and study protocols.

What must SOPs detail in an animal facility?

Procedures for equipment use, sanitization methods, feed and bedding storage, cage cleaning, and blood collection.

Why must staff read and understand SOPs?

To ensure they can perform procedures correctly and have easy access to the instructions.