Inspection Strategy for Semen Establishments
(POLICY-0023)

(November 5, 2007)

Unit Name: BTOX Compliance Unit
Telephone: (613) 954-5011
Fax: (613) 946-5636
Email: BTOX_STOX@hc-sc.gc.ca

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Cover Letter

Health Products and Food Branch Inspectorate
Graham Spry Building, 3^rd Floor
250 Lanark Avenue
Address Locator # 2003C
Ottawa, Ontario
K1A 0K9

November 5, 2007

07-122886-611

To : All Interested Parties

Health Canada is pleased to inform you of the latest release of the Document entitled "Inspection Strategy for Semen Establishments". This Policy Document has been revised to update the inspection frequency for final (physician) distributors. The national inspection programme assesses compliance of establishments processing, distributing and/or importing donor semen to the requirements of the Processing and Distribution of Semen for Assisted Conception Regulations.

This document provides guidance on the inspection cycle of semen establishments and their corresponding activities. Furthermore, it is intended to maintain consistency of inspections across the country and to foster transparency of the national inspection programme.

Inquiries about this policy can be addressed to the BTOX Compliance Unit by e-mail at BTOX_STOX@hc-sc.gc.ca or you may contact a Compliance Specialist in any of the following Operational Centres:

• Atlantic: 902-426-6748
• Quebec: 450-646-1353
• Ontario & Nunavut: 416-973-1596
• Manitoba & Saskatchewan: 204-984-1341
• British Columbia, Alberta, Northwest Territories & Yukon: 604-666-3896

Further information on the regulation of donor semen for assisted conception is available on the Health Canada website.

Yours sincerely,

Original signed by

Diana Dowthwaite
Director General

Cover Page

Our Mandate :

To promote good nutrition and informed use of drugs, food, medical devices and natural health products, and to maximize the safety and efficacy of drugs, food, natural health products, medical devices, biologics and related biotechnology products in the Canadian marketplace and health system.

Health Products and Food Branch Inspectorate

Inspection Strategy For Semen Establishments

(POLICY-0023)

Supersedes:
July 12, 2007

Date issued:
November 1, 2007

Date of implementation:
November 1, 2007

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Table of Contents

• 1.0 Purpose
• 2.0 Background
• 3.0 Scope and Objectives
• 4.0 Definitions
• 5.0 Procedures
  
  
  • 5.1 Inspection
    • 5.1.1 Classification of Activities
    • 5.1.2 Inspection activity (Refer to attached Appendix)
    • 5.1.3 Inspection Duration
    • 5.1.4 Inspection Rating and Reporting
  • 5.2 Response to Non-Compliance
  
  
• 6.0 Responsibilities
• 7.0 Effective Date
• 8.0 Associated Documents
• 9.0 Authors
• 10. Appendix

1.0 Purpose

The purpose of this document is to detail the national inspection strategy which assesses compliance of establishments processing, distributing and/or importing donor semen with the requirements of the Processing and Distribution of Semen for Assisted Conception Regulations.

2.0 Background

Donor semen for assisted conception is regulated by Health Canada as a drug under the authority of the Food and Drugs Act (F&DA) and the Processing and Distribution of Semen for Assisted Conception Regulations (Semen Regulations). The Semen Regulations reference clauses 2 to 5 of the Health Canada Directive entitled Technical Requirements for Therapeutic Donor Insemination (Directive). The referenced sections of the Directive, entitled "Exclusions", "Work-Up", "Repeat Screening & Quarantine" and "Microbiology", set forth requirements for donor screening and infectious disease testing aimed at reducing the potential risk of transmitting infectious agents through the use of donor semen in assisted conception. The requirements set out within the Directive have the force of law due to the fact that they are incorporated by reference into the Semen Regulations.

The authority to perform inspections, compliance verification activities and investigations is derived from section 23 of the F&DA. Collaboration with all stakeholders involved in processing, distributing and/or importing donor semen for use in assisted conception will be essential to ensure a high level of compliance with the Semen Regulations.

3.0 Scope and Objectives

The scope of the inspection strategy is all known Canadian semen establishments that process, distribute and/or import donor semen used in assisted conception.

The main objectives of this inspection strategy are:

1. To minimize the health risk associated with the use of donor semen in assisted conception
   
2. To assess, through inspections, the compliance of semen establishments with the Semen Regulations
   
3. To take compliance and enforcement action where deemed necessary
   
4. To maintain consistency of inspections across the country
   
5. To foster transparency of the National Inspection Programme

Disclaimer

This document does not constitute part of the Food and Drugs Act (Act) or the Food and Drugs Regulations (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. This document is not intended to provide legal advice regarding the interpretation of the Act or Regulations. If a regulated party has questions about their legal obligations or responsibilities under the Act or Regulations, they should seek the advice of legal counsel.

4.0 Definitions

Compliance Verification: Actions taken to verify compliance in response to information regarding known or suspected non-compliance with the applicable requirements of the F&DA and its associated Regulations. This includes actions such as information gathering either off-site or via on-site visits.

Donor: A man who donates sperm/semen for use in assisted conception.

Distributor (Semen): A person or an establishment that sells/distributes donor semen for use in assisted conception.

Establishment (Semen): A person, including an association or partnership, who under their own name, a trade name, or other name process, distribute and/or import donor semen for use in assisted conception.

Final (physician) Distributor: A physician who distributes directly to patients via assisted conception procedures.

Guidelines: Clarifying and descriptive documents which inform users of regulations. It should be noted that guidelines are not regulatory standards; they outline in plain language what steps are to be taken to meet regulatory requirements. Guidelines may, however, exceed regulatory requirements in some respect.

Importer (Semen): A person or establishment that imports donor semen from a foreign country for use in assisted conception.

Inspection: On-site monitoring and assessment against the applicable requirements of the F&DA and its associated Regulations. Inspections are routinely conducted on a predetermined cycle or as required to assess compliance.

Inspector: Any person designated as an inspector for the purpose of the enforcement of the F&DA under subsection 22(1) or the Controlled Drugs and Substances Act (CDSA) under Section 30.

Processor (Semen): A person or establishment that collects, tests, prepares, preserves, labels and stores donor semen for use in assisted conception.

Recipient: A woman who is inseminated with donor semen for the purpose of assisted conception.

Regular Inspection: A regular inspection is an assessment of the semen establishment against all applicable criteria of the Semen Regulations.

For additional definitions, consult the documents listed as references at the end of this strategy.

5.0 Procedures

5.1 Inspection

The Inspectorate will provide information and encourage voluntary compliance with Canadian regulatory requirements. Compliance may be assessed through inspection, compliance verification, investigation and communication with establishments.

Donor semen for use in assisted conception is regulated as a drug under Canada's F&DA. For this reason, the Inspectorate developed an inspection strategy for processors, importers, distributors and final (physician) distributors of donor semen.

5.1.1 Classification of Activities:

An inspection schedule is appended to this strategy and describes the types of establishments which deal with donor semen in Canada, their type of activities, the frequency of inspection, the rationale for the frequency of inspection and the follow-up activities. If an establishment carries out more than one activity e.g. imports and distributes within their clinic, the frequency of inspection for the establishment is based on the activity of highest risk.

Establishments that have an inventory of donor semen that they have processed or imported (but are no longer processing or importing) will continue to be classified as a processor or importer, respectively, until that inventory is used, destroyed, or reclassified for other purposes outside the jurisdiction of the Semen Regulations (e.g. for research only). The one exception is when the establishment declares, in writing, that the donor semen will only be distributed after obtaining authorization via the Donor Semen Special Access Programme. In this case, the classification will be changed to distributor or final (physician) distributor but the establishment (processor or importer) will still be required to comply with the requirements of the Semen Regulations as a processor or importer. The change of status is administrative only as it effects the frequency of inspection.

5.1.2 Inspection activity (Refer to attached Appendix):

• All known processors and importers will be inspected every fiscal year (April 1 to March 31).
  
• Distributors that further distribute donor semen will be placed in a 2-year inspection cycle.
  
• Final (physician) distributors will be placed in a 5-year inspection cycle.
• Newly identified distributors and final (physician) distributors will be contacted to ensure they are aware of their regulatory requirements. Once their activities are verified an inspection will be scheduled.
• Inactive processors and importers that still hold that status even though they are not actively processing or importing will be contacted on a yearly basis to confirm whether there are changes in their activities. If the establishment doesn't report any change on their status, they will be inspected based on the activity that they are conducting.
• Regular inspections will be conducted as announced inspections and this will allow for sufficient preparation time for the concerned parties. Other types of inspections or compliance verification activities may be conducted at the discretion of Health Canada and may be unannounced.
• Specific inspection and compliance verification activities will be documented and supported by detailed standard operating procedures.
  
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5.1.3 Inspection Duration:

• The average time for a regular inspection will vary depending on the type of activities and by the size of the establishment. The duration could vary from one to three days at an establishment.

5.1.4 Inspection Rating and Reporting:

• Two ratings will be used:
  
  • compliant: at the time of the inspection, the establishment has demonstrated that it is in control of regulated activities pertaining to the Semen Regulations; and
  • non-compliant: at the time of the inspection, the establishment has not demonstrated that it is in control of regulated activities pertaining to the Semen Regulations.
• Reports will be generated using the Inspection Reporting System of the Inspectorate and will be issued to semen establishments in a timely manner.
• Responses to observations made in the Inspection Report (Inspection Exit Notice) will be required from the party being inspected.
• A formal appeal process to allow a semen establishment to appeal rating decisions is being developed by the Inspectorate.

5.2 Response to Non-Compliance

Where non-conformity to the Act and/or Regulations is identified, the semen establishment will have the opportunity to correct identified deficiencies. Where necessary, the Inspectorate will consider enforcement actions in accordance with the Health Products and Food Branch Inspectorate's Compliance and Enforcement Policy No. POL-0001.

6.0 Responsibilities

Compliance will be assessed through inspections conducted by BTOX compliance specialists of the Inspectorate of Health Canada, designated under Section 22(1) of the F&DA. Inspections for compliance with the Food and Drugs Act, the Processing and Distribution of Semen for Assisted Conception Regulations, and the Health Canada Directive entitled Technical Requirements for Therapeutic Donor Insemination are conducted under the authority of Section 23 of the F&DA, with reference to relevant policies and guidance documents.

7.0 Effective Date

The implementation date of this Inspection Strategy is November 1^st, 2007.

8.0 Associated Documents

1. Food and Drugs Act
2. Processing and Distribution of Semen for Assisted Conception Regulations
3. Health Products and Food Branch Inspectorate Compliance and Enforcement Policy, No. POL-0001
4. Health Products and Food Branch Inspectorate Formal Hearing, Prosecution and Injunction Policy, No. POL-0006
5. Health Products and Food Branch Inspectorate Seizure Policy, No. POL-0007
6. Health Canada Directive - Technical Requirements for Therapeutic Donor Insemination
7. Health Canada - Guidance on the Processing and Distribution of Semen for Assisted Conceptions Regulations, No. GUI-0041
8. Health Canada - Guidance on the Risk Classification of Observations to Semen Establishments, No. GUI-0053.

9.0 Authors

BTOX Compliance Specialists

10. Appendix

Inspection Schedule

Type of Establishment	Activities of Establishment	Frequency of Inspection	Rationale for Frequency of Inspection	Follow-up Activities
Processor	Collection, donor screening, donor testing, labelling, preparation, preservation, storage, distribution, investigation, notification to the Inspectorate, product recalls, equipment (calibration, maintenance, validation), record keeping, etc.	Inspection every fiscal year (April 1 to March 31).	product: high risk activity: high risk processors are also distributors: (they distribute to other establishment(s) for further distribution, to physician(s) for use in assisted conception and/or directly to a woman via the assisted conception procedure) consistency of inspection frequency with other high risk products regulated by the Inspectorate	As needed based on: compliance history changes within the establishment (staff and/or operational changes) amendments to the Semen Regulations others
Importer	Importation, review of SOPs and records of foreign supplier to verify compliance with Canadian Regulations, storage, distribution, investigation, notification to the Inspectorate, product recalls, record keeping, etc.	Inspection every fiscal year (April 1-March 31).	product: high risk activity: high risk importers are also distributors: (they distribute to other establishment(s) for further distribution, to physician(s) for use in assisted conception and/or directly to a woman via the assisted conception procedure) consistency of inspection frequency with other high risk products regulated by the Inspectorate the inspection verifies that the importer is importing compliant donor semen	As needed based on: compliance history changes within the establishment (staff and/or operational changes) amendments to the Semen Regulations others
Distributor	Distributors that further distribute e.g. broker storage, distribution, investigation, product recalls, record keeping, etc.	Inspection every two years, based on the fiscal year (April 1-March 31) .	product: high risk activity: medium risk distributor / broker: (they distribute to other establishment(s) for further distribution and/or to physician(s) for use in assisted conception) consistency of inspection frequency with other high risk products regulated by the Inspectorate processors and importers that supply donor semen to the distributor have been assessed by Health Canada for compliance	As needed based on: compliance history changes within the establishment (staff and/or operational changes) amendments to the Semen Regulations others
	Final (physician) Distributor: storage, distribution, investigation, product recalls, record keeping, etc.	Inspection every five years, based on the fiscal year (April 1-March 31).	product: high risk activity: low risk Final (physician) distributor distributes directly to a woman via assisted conception procedures. Product (donor semen for assisted conception) has already been the subject of more frequent compliance inspections as per the schedule for processors, importers and distributors that further distribute.	As needed based on: compliance history changes within the establishment (staff and/or operational changes) amendments to the Semen Regulations others