Guidance on classification of observations for inspecting cells, tissues and organs establishments (GUI-0101): Overview
Date issued: August 29th, 2025
Replaces: Guidance on Classification of Observations for Inspection of Cells, Tissues and Organs establishments (March 15, 2017)
Disclaimer: This document does not constitute legislation. If there is any inconsistency or conflict between the legislation and this document, the legislation takes precedence. This document is an administrative document intended to facilitate compliance by the regulated party with the legislation and the applicable administrative policies.
On this page
Purpose
Establishments that process, import, distribute or handle human cells, tissues and organs (CTO) intended for transplantation must comply with the Food and Drugs Act (act) and the Safety of Human Cells, Tissues and Organs for Transplantation Regulations (CTO regulations).
Health Canada inspects CTO establishments for compliance with the act and regulations.
This guide:
- provides examples of inspection observations
- describes how Health Canada inspectors classify observations
- describes how overall compliance ratings are assigned to an inspection
- includes situations that may result in a non-compliance rating
- promotes consistency in individual observations and in overall inspection ratings
You should read this document along with the following:
- Food and Drugs Act
- Safety of Human Cells, Tissues and Organs for Transplantation Regulations
- relevant sections of CAN/CSA Z900: Cells, tissues, and organs for transplantation: General requirements, along with 4 of the 5 subset standards (for lymphohematopoietic cells, perfusable organs, tissues and ocular tissues)
- Guidance document for cell, tissue and organ establishments - Safetyof human cells, tissues and organs for transplantation
- Inspection policy for cells, tissues and organ establishments (POL-0057)
- Registration policy for cells, tissues and organs establishments under the Safety of Human Cells, Tissues and Organs for Transplantation Regulations (POL-0123)
You may ask for a copy of the registration policy by emailing us: roeb.cto-dgoral@hc-sc.gc.ca.
A Health Canada regulated party must understand its obligations under the act and comply with those requirements. Regulated parties that fail to comply will be subject to compliance and enforcement actions.
For more information, consult:
Scope
This guide applies to all establishments regulated under the CTO regulations.