Biosafety program management

Overview

This guideline provides comprehensive guidance on how to develop, implement, and manage a biosafety program in facilities that handle and store human and terrestrial animal pathogens. The guideline outlines the steps essential to the development and execution of a comprehensive biosafety program, which includes planning, implementing, reviewing, and improving the program. Use this guideline in conjunction with the Canadian Biosafety Standard.

Who this guide is for

• Pathogen and Toxin Licence holders
• Biological safety officers
• Personnel in regulated facilities

In this guide

• Preface
• Abbreviations and acronyms
• 1. Introduction
  • 1.1 Scope
  • 1.2 How to use the Biosafety Program Management Guideline
• 2. Plan a biosafety program
  • 2.1 Promoting a culture of biosafety
  • 2.2 Biosafety and biosecurity risk assessments
• 3. Implement the biosafety program
  • 3.1 Core elements of the biosafety program
  • 3.2 Communication plan
  • 3.3 Records and documentation
• 4. Ongoing improvement of the biosafety program
  • 4.1 Incident investigation
  • 4.2 Internal audits and inspections
  • 4.3 Biosafety program and management review
  • 4.4 Implementation of corrective and preventive measures
  • 4.5 Managing change
  • 4.6 Ongoing improvement
• 5. Glossary
• 6. References

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Details and history

Published: March 31, 2023

For assistance

Related services

• Apply for a Pathogen and Toxin Licence
• Apply for an animal pathogen import permit (Canadian Food Inspection Agency)

Related guides and help

• Canadian Biosafety Standard
• Canadian Biosafety Handbook
• Pathogen Safety Data Sheets (PSDS)
• Pathogen Risk Assessment Template

Related acts and regulations

• Health of Animals Act
• Health of Animals Regulations
• Human Pathogens and Toxins Act
• Human Pathogens and Toxins Regulations

Related programs

• Biohazard Containment and Safety (CFIA)
• Human Pathogen and Toxin Licensing Program