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Inspection Strategy for Cells, Tissues and Organs Establishments (POL-0057)
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(PDF Version - 120 K)Introduction
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).
Our Mandate
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: New document
Date issued: November 21, 2012
Date of Implementation: November 21, 2012
Disclaimer
This document does not constitute part of the Food and Drugs Act (Act) or it's associated Regulations and in the event of any inconsistency or conflict between that 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
- 1.0 Purpose
- 2.0 Background
- 3.0 Scope
- 4.0 Definitions
- 5.0 Policy Statement
- 6.0 Responsibilities
- 7.0 Inspection Program
- 7.1 Approach
- 7.2 First Inspection
- 7.3 Second Inspection
- 7.4 Subsequent Inspection
- 7.4.1 Inspection Frequency
- 7.5 Inspection Duration
- 7.6 Inspection Rating and Reporting
- 7.6.1 Risk Rating
- 7.6.2 Overall Rating
- 7.6.3 Reporting
- 8.0 Response to Non-Compliant Rating
- 9.0 Effective Date
- 10.0 Definitions
- 11.0 Author
1.0 Purpose
The purpose of this document is to detail 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).
2.0 Background
Health Canada is committed to taking an integrated approach to managing the health related risks and benefits of health products by minimizing health risk factors to Canadians while maximizing the safety provided by the regulatory system for health products and food; and promoting conditions and providing information that enable Canadians to make informed decisions about their health.
Health Canada meets these commitments, in part through an inspection program which facilitates both compliance promotion and enforcement of the regulations, thereby helping to minimize health risks associated with the health products.
The CTO Regulations came into force on December 7, 2007, except for subsection 26(1) which came into force on June 7, 2008. In August 2009, Health Canada began inspecting all registered CTO establishments and issued reports which summarized deficiencies found during each inspection. Effective April 2012, Health Canada began classifying individual observations as critical, major, or minor. This is in addition to the overall rating of compliant or non-compliant that is assigned following an inspection. The intent is to provide additional information to establishments with regards to their level of compliance with the CTO Regulations. All ratings are assigned in accordance with the principles and guidelines set forth in the Guidance on Classification of Observations for Inspection of Cells, Tissues, and Organs Establishments (GUI-0101).
As part of the development of this inspection strategy, Health Canada conducted a consultation that allowed stakeholders to comment and provide feedback on several inspection strategy options presented to them. It is through this feedback that Health Canada developed the Inspection Strategy for Cells, Tissues and Organs Establishments (POL-0057). A summary of the comments received from stakeholders has been compiled and is posted on the Health Canada Website along with this document.
3.0 Scope
This inspection strategy applies to all registered Canadian establishments that are conducting activities under the CTO Regulations.
4.0 Definitions
- 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 or a recognized standard.
- Enforcement:
- Actions that may be taken to induce, encourage or compel compliance with the Act and its associated regulations.
- Inspection:
- On-site monitoring and assessment against the applicable requirements of the Act and its associated regulations. Inspections are routinely conducted on a predetermined cycle or as required to assess compliance.
5.0 Policy Statement
All individuals and establishments in Canada that handle, process, distribute or import human organs or minimally manipulated cells and tissues for homologous use in transplantation in another individual must comply with the requirements of the CTO Regulations.
6.0 Responsibilities
Inspections are conducted to assess compliance with the Act and the CTO Regulations and are conducted under the authority of Section 23 of the Act, with reference to relevant policies and guidance documents. Health Canada inspectors are designated under section 22(1) of the Act.
7.0 Inspection Program
An inspection is an on-site assessment of an establishment's activities, procedures and ability to comply with the applicable requirements of the Act and its associated regulations.
Health Canada inspects registered Canadian cells, tissues and organs establishments to assess their compliance with the Act and the CTO Regulations. Please note that in this document the terms "establishment" and "program" are being used interchangeably as one establishment may have several distinct programs.
7.1 Approach
In most cases, the establishment/program is given prior notice of the inspection. The regional inspector makes initial contact with the establishment/program to schedule an inspection and confirm the information in the CTO Registration Certificate. The inspector then sends the establishment/program a confirmatory letter and, if required, a pre-inspection package containing documents regarding the inspection process.
Unannounced inspections may be conducted in situations where it is anticipated that this approach will provide a more accurate compliance assessment or when an immediate risk to health and safety has been identified.
7.2 First Inspection
Establishments/programs will be inspected within 24 months of being registered with Health Canada.
7.3 Second Inspection
Establishments or programs that receive a Compliant (C) overall rating at their first inspection will be inspected for the second time within 24-36 months of the first inspection.
Establishments/programs that receive a Non-Compliant (NC) overall rating at the first inspection will be re-inspected usually within 6-12 months following the first inspection. The scope of the re-inspection will be determined by the inspector.
7.4 Subsequent Inspections
Depending on the results of the first and second inspections, the frequency of the inspections will be established as described in Section 7.4.1.
7.4.1 Inspection Frequency
The Inspection frequency is based on two factors, namely (1) the intrinsic risk of the activities being conducted and (2) the overall rating results of the last two inspections.
The determination of the inspection frequency is a three step process:
- Assess the intrinsic risk of the establishment/program activities;
- Assign a designation based on the overall rating of the last two inspection; and
- Determine inspection frequency.
Step 1: This step assesses the intrinsic risk of the program activities. Source establishments are responsible for processing and determining that the CTO are safe for transplantation; thus the processing activities conducted by source establishments are categorized as high risk. Importers and distributors are not responsible for determining the safety of the CTO; thus their activities are considered medium risk. Currently no activities are considered to be low risk. See Table No. 1.
For establishments that have several CTO programs, the frequency of inspections could be based on the compliance status of each of their distinct programs.
Activity |
Risk Category |
|---|---|
| Processing | High |
| Importing for further distribution | Medium |
| Distributing | Medium |
Step 2: This step assigns a designation based on the overall rating of the last two inspections (referred to as Inspection #1 and Inspection #2, see Table No. 2).
An establishment/program will be designated as A1 if the last two inspections resulted in an overall Compliant (C) rating.
An establishment/program with an overall Non-Compliant (NC) rating at the first inspection (for Example: Inspection #1) will be subject to a re-inspection, where the re-inspection will be considered as Inspection #2. Depending on the results of the re-inspection (Inspection # 2) of either Compliant (C) or Non-Compliant (NC), a designation of A2 or A3 will be assigned, respectively.
Designation |
Inspection #1 |
Inspection #2 |
|---|---|---|
| A1 | C | C |
| A2 | NC | C |
| A3 | NC | NC |
C= Compliant, NC= Non-Compliant
Step 3: This step determines the inspection frequency based on the intrinsic risk of activities conducted (Step 1) and the last two inspection results (Step 2).
Under A1 designation, establishments/programs will be inspected within 24 to 36 months. For example, establishments/programs that conduct medium risk activities such as importers that further distribute may be inspected every 36 months while establishments/programs conducting high risk activities will be inspected anywhere between 24 to 36 months.
Under A2 designation, depending on the risk of activities, establishments/programs could be inspected within 12 to 24 months.
Under A3 designation, the scope and timelines of the re-inspection will be determined by the inspector following the issuance of the NC rating. In general, an establishment/program will be re-inspected within 6-12 months following an NC rating.
Table No. 3 summarizes the inspection frequency as described above.
Designation |
|||
|---|---|---|---|
A1 |
A2 |
A3 |
|
| Frequency of Inspections | 24-36 months | 12-24 months | 6-12 months |
Establishments/programs may be inspected more frequently than described above if Health Canada becomes aware of a potential non-compliance at an establishment/program that could result in a risk to health and safety.
7.5 Inspection Duration
In general, the duration of the inspection will be determined by the inspector on a case by case basis. The average time for a regular inspection will vary depending on the type of activities, number of inspectors and size of the establishment/program.
7.6 Inspection Rating and Reporting
7.6.1 Risk Rating
All observations are documented in the inspection report (Exit Notice) along with the overall rating of the establishment/program. Each observation is assigned a risk rating according to GUI-0101.
An observation is classified in accordance with the level of risk associated with the deficiency.
The observations are classified as Critical, Major or Minor.
- Critical observation (Risk 1)
- Any observation that directly affects the safety of the product(s) and is likely to result in an immediate or latent health risk to the recipient; or
- Fraud, misrepresentation or falsification of product(s) or data.
- Major observation (Risk 2)
- Any observation that potentially affects the safety of the product(s) and could result in an immediate or latent health risk to the recipient.
- Minor observation (Risk 3)
- Any observation that has low or negligible impact on the safety of the product(s).
7.6.2 Overall Rating
One of the following overall ratings will be assigned:
- Compliant (C): at the time of the inspection, the regulated party has demonstrated that the activities it conducts are in compliance with the Act and its associated regulations.
- Non-compliant (NC): at the time of the inspection, the regulated party has not demonstrated that the activities it conducts are in compliance with the Act and its associated regulations.
When an NC rating is assigned, a re-inspection will be conducted. The scope and timelines of the re-inspection will be determined by the inspector following the issuance of the NC rating. In general, the focus of the re-inspection will be on the areas of non-compliance but other areas and activities may still be reviewed and the re-inspection Exit Notice may include observations relating to previously compliant areas.
7.6.3 Reporting
All observations, their risk rating and the overall rating of the establishment/program will be provided to the establishment/program in the Exit Notice. The establishment/program will be given 20 working days to provide a written response to the observations and this written response is to be sent directly to the regional inspector who conducted the inspection.
If the management of the CTO establishment/program wishes to dispute the results of the inspection Exit Notice, the establishment/program has five working days (excluding weekends and holidays) from the receipt of the Exit Notice to bring its concerns to the attention of Health Canada. If the establishment/program chooses to exercise this option, it must do so in a written submission outlining the basis of the disagreement and citing the specific sections of the inspection Exit Notice that are contentious. Data that was not presented at the time of inspection will not be considered as part of the dispute management process but would be considered as part of the corrective actions. The dispute submission is to be forwarded directly to the regional office as noted in the accompanying letter of the Exit Notice. Should the dispute not be resolved at that level, the establishment/program will be advised of the process which may be used.
8.0 Response to Non-Compliant Rating
Where non-conformity with the Act and/or Regulations is identified, the CTO establishment/program will have the opportunity to correct the identified deficiencies.
An NC rating will have serious consequences for an establishment/program and may result in the cancellation of its CTO establishment/program registration. Enforcement actions will be taken as required and in accordance with Health Canada's Compliance and Enforcement Policy, POL-0001.
9.0 Effective date
November 21, 2012
10.0 Associated Documents
- Food and Drugs Act (Act)
- Safety of Human Cells, Tissues and Organs for Transplantation Regulations (CTO Regulations).
- National Standard of Canada CAN/CSA-Z900.1 entitled Cells, Tissues, and Organs for Transplantation and Assisted Reproduction: General Requirements.
- National Standard of Canada CAN/CSA-Z900.2.2 entitled, Tissues for Transplantation.
- National Standard of Canada CAN/CSA-Z900.2.3 entitled, Perfusable Organs for Transplantation.
- National Standard of Canada CAN/CSA-Z900.2.4 entitled, Ocular Tissues for Transplantation.
- National Standard of Canada CAN/CSA-Z900.2.5 entitled, Lymphohematopoietic Cells for Transplantation.
- Guidance Classification of Observations for Inspection of Cells, Tissues and Organs Establishments (GUI-0101).
- Compliance and Enforcement Policy (POL-0001).
11.0 Authors
Inspectorate
