Inspection Policy for Cells, Tissues and Organs Establishments (POL-0057)
POL-0057 details the strategy for the effective and uniform implementation of a national program for scheduling the inspections of Canadian registered establishments that handle and/or process human cells, tissues and organs (CTO) in order to assess compliance against applicable requirements of the Food and Drugs Act (Act) and the Safety of Human Cells, Tissues and Organs for Transplantation Regulations (CTO Regulations).
To manage and deliver a national compliance and enforcement program for blood and donor semen; cells, tissues and organs; drugs (human and veterinary); medical devices and natural health products, collaborating with and across, all regions.
Supersedes: November 21, 2012
Date issued: March 15, 2017
Date of Implementation: March 15, 2017
This document does not constitute part of the Food and Drugs Act (the Act) or its regulations and in the event of any inconsistency or conflict between the Act or regulations and this document, the Act or the regulations take precedence. This document is an administrative document that is intended to facilitate compliance by the regulated party with the Act, the regulations and the applicable administrative policies.
Table of Contents
About this document
Health Canada inspects establishments that process, distribute or import human cells, tissues and organs (CTO) for transplantation. These inspections help monitor establishments that handle CTO for transplant in order to minimize the potential health risks to Canadian recipients of human CTO.
This policy describes the inspection process we use to assess whether a CTO establishment is complying with the:
- Food and Drugs Act (the Act)
- Safety of Human Cells, Tissues and Organs for Transplantation Regulations (CTO Regulations)
Health Canada's authority to inspect CTO establishments comes from sections 22(1) and 23 of the Act.
This policy applies to any Canadian CTO establishment registered with Health Canada whose activities are governed by the CTO Regulations.
Specifically, it applies to establishments that do any of the following activities with CTO for transplantation into another person:
3. Inspection process
Before an inspection:
In most cases, Health Canada gives notice to an establishment before an inspection takes place. An inspector contacts the establishment to schedule the inspection and then sends a communication confirming the inspection's date and time. The establishment may also receive a pre-inspection package, which gives more details about the inspection process.
Unannounced inspections may be conducted if:
- there is an immediate risk to health and safety, or
- this approach will more accurately assess the establishment`s compliance with the Act and CTO Regulations.
During an inspection:
During an inspection, our inspectors observe and discuss the CTO establishment's existing processes and review its records, documents and procedures. They look carefully at many different areas to assess compliance, including but limited to:
- quality system assurance
- exceptional distribution
- error, accident and adverse reaction investigation and reporting
- staff training
- equipment maintenance
- use of critical supplies
Inspectors make observations when they note areas where the establishment is not adequately meeting its regulatory requirements. Each observation is classified by level of risk:
Inspectors will communicate their findings to the establishment during the course of the inspection. It may be possible for the establishment to correct the observations during the inspection itself. If not, the establishment must take corrective actions after the inspection to address the observations.
After an inspection:
After completing an inspection, the inspector creates a report (Exit Notice) that:
- documents the observations
- issues an overall inspection rating to the establishment
The overall rating indicates whether the establishment is compliant or non-compliant with the requirements of:
- the Act
- CTO Regulations
The rating is based on observations noted by the inspector and includes:
- the number of observations
- risk level of each observation
A compliant (C) rating means the establishment is complying with the Act and CTO Regulations. Getting a compliant rating does not mean there were no issues during the inspection. An establishment will still need to take corrective actions to address any deficiencies noted against the Act and the CTO Regulations.
A non-compliant (NC) rating could mean that the establishment:
- has not shown that its activities comply with the Act and CTO Regulations
- will need to take immediate corrective actions
Health Canada may cancel an establishment's registration in some cases.
Establishments have 20 working days to provide a written response to the Exit Notice. This written response must be sent directly to the inspector.
When an establishment is given a non-compliant rating, it must address the deficiencies by creating and implementing a detailed corrective action plan. The plan must include target dates for completion.
Inspection report cards:
Health Canada posts report cards for CTO inspections. Each inspection report card summarizes the inspection observations and ratings, and makes them available to the public. You can find them here:
4. Inspection frequency and duration
How often we conduct inspections:
CTO establishments are inspected within 24 months of registering with Health Canada. After this initial inspection, we use the following steps to determine how often an establishment will be inspected:
1. We assess the level of risk of the establishment's activities: high, medium or low.
High: The processing of CTO is considered to be a high risk activity. Establishments that are responsible for processing CTO and determining if they are safe for transplantation are known as "source establishments."
A CTO establishment is considered a source establishment if it is:
- an organ donation organization (for organs from deceased donors)
- a tissue bank (For tissues or for adjunct vessels retrieved with an organ and not used immediately in organ transplantation)
- a transplant establishment (for organs from a living donor or lymphohematopoietic cells that are not banked)
- a cell bank (banked lymphohematopoietic cells)
- an establishment that prepares cells for use in transplantation (for islet cells)
Processing of CTO can include:
- suitability assessment
- packaging and labelling
- retrieval (except in the case of organs and islet cells)
- preparation for use in transplantation (except for organs)
- testing and measurements performed on CTO after they are retrieved
Medium: Importers and distributors are responsible for storing and transporting CTO that have already been deemed safe for transplantation. For this reason, their activities are considered medium risk.
Low: Currently, no activities related to CTO are considered low risk.
2. We review the overall rating of the last inspection(s).
- Establishments conducting high risk activities with a compliant rating at the last inspection will be inspected within 24-36 months.
- Establishments conducting medium risk activities with a compliant rating at the last inspection will be inspected within 30-36 months.
- Establishments with a non-compliant rating at the last inspection will:
- have the scope and timeline of the re-inspection determined by the inspector but is generally re-inspected within 6-12 months
- Establishments that received a non-compliant rating at one inspection and then a compliant rating at the next inspection will be inspected within 12-24 months.
Establishments may be inspected more often if Health Canada believes there is a potential risk to the health and safety of Canadians.
How long inspections last:
In general, inspectors determine the length of each inspection on a case-by-case basis. The average time for an inspection varies depending on the:
- complexity and number of an establishment's activities
- number of inspectors
- size of the establishment
5. Contact information
For questions about the inspection process, please contact the Biological Product Compliance Program: BPCP_PBPB@hc-sc.gc.ca
Appendix A - Glossary
These definitions explain how terms are used in this document. If there is a conflict with a definition in the Food and Drugs Act or CTO Regulations, the definition in the Act or Regulations prevails.
Compliance - The state of conformity of a regulated party (including a corporation, institution, individual or other legal entity) or a product with a legislative or regulatory requirement.
Enforcement - Actions that may be taken to induce, encourage or compel compliance with the FDA and its associated Regulations.
Inspection - Monitoring and assessment of compliance against any of the applicable requirements of the Food and Drugs Act and its associated Regulations by a designated inspector. Inspections are conducted at pre-determined intervals or on a risk basis.
Appendix B - Reference
Laws and regulations
Guidance documents and policies
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