Guidelines for environmental control of drugs during storage and transportation (GUI-0069) - Summary

Overview

These guidelines will help all persons (individuals and companies) who store and/or transport drugs to comply with Canada’s Food and Drugs Act (the Act) in accordance with C.02.015 of the Food and Drug Regulations (the Regulations).

Guidance documents like this one are meant to help industry and health care professionals understand how to comply with regulations. They also provide guidance to Health Canada staff, so that the rules are enforced in a fair, consistent and effective way across Canada.

Health Canada inspects establishments to assess their compliance with the Act and associated regulations. When conducting an inspection, Health Canada will use this document as a guide in assessing your compliance with GMP requirements.

Who this guide is for

These guidelines apply if you or your company are involved in storing or transporting the following drugs:

• drugs for human use
• drugs for veterinary use
• clinical trial drugs for human use (as required by C.05.010(j))
• samples of drugs distributed to professionals (as outlined in Sections C.01.048 and C.01.049 of the Regulations)

In this guide

• About this document
  1. Purpose
  2. Scope
  3. Introduction
• Guidance
  • Principles
    • 4.1 The role of environmental controls
    • 4.2 About Quality Risk Management (QRM)
    • 4.3 Special considerations for Active Pharmaceutical Ingredients (API)
  • Interpretation
    • 5.1 Warehousing and storage
    • 5.2 Product transportation
    • 5.3 Containers and container labelling
    • 5.4 Receiving
    • 5.5 Documentation
• Appendices
  • Appendix A – Glossary
    • Acronyms
    • Terms
  • Appendix B – References
    • Laws and regulations
    • Health Canada guidance documents
    • International guidance documents
    • Other related documents

View complete guide

Download PDF (PDF format, 1085 KB, 23 pages)

Details and history

Published: August 24, 2020

Updated: August 24, 2020

Consulted: December 20, 2018 - March 20, 2019

For assistance

By email hc.drug.gmp.questions-bpf.medicaments.sc@canada.ca

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