Contract Sterilization letter

Health Products and Food Branch Inspectorate
2nd Floor, Graham Spry Building
250 Lanark Avenue
A.L. 2002A
Ottawa, Ontario
K1A 0K9

September 1, 2009

To: Establishment Licence Holders

Re: Contract sterilization of primary packaging materials used in the manufacture of aseptically filled sterile drug products

This letter is intended to clarify Health Canada's position on the regulatory requirements for companies conducting sterilization (eg. gamma radiation, Ethylene Oxide (EtO)) of primary packaging materials used in the manufacture of aseptically filled sterile drug products which do not undergo terminal sterilization.

As per Division 1A and Division 2 (in particular, section C.02.029) of the Food and Drug Regulations, Health Canada asserts that:

  1. the activity of sterilizing packaging materials used in the preparation of aseptically filled sterile products is considered a licensable activity
  2. these activities must be conducted in accordance with an establishment licence
  3. the individual conducting the aforementioned licensable activity must themselves hold an establishment licence to do so, and
  4. the authority granted the holder of such a licence is not transferable to a third party.

All current Establishment License (EL) holders authorized to Fabricate, Package, Import and Distribute sterile drug products are advised to ensure that third-party companies who perform such activities, do so in accordance with Division 1A, and Division 2 of the Food and Drug Regulations.

Current EL holders employing foreign third-party sterilization companies will require an amendment to their Establishment Licence, within 12 months.

In the case of current EL holders employing domestic third-party sterilization companies, they will be required to secure a licenced facility to perform contracted drug product associated sterilization activities within 12 months.

For guidance regarding the information required for foreign sites please refer to sections 3.1 and 3.2 of the guidance document "Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites" (GUI-0080), which is available on the Health Canada website at:

http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/index-eng.php

All establishments are expected to comply with this requirement within the time prescribed by this letter. Failure to comply with the Food and Drug Act and its associated Regulations will necessitate compliance and enforcement action in accordance with Health Canada's "Compliance and Enforcement Policy" (POL-0001) as well as the "Good Manufacturing Practices and EL Enforcement Directive" (POL-0004) which are available on the Health Canada website at:

http://www.hc-sc.gc.ca/dhp-mps/compli-conform/activit/index-eng.php

Should you have any questions please do not hesitate to contact us at DEL_questions_LEPPP@hc-sc.gc.ca. We thank you for your cooperation.

Diana Dowthwaite
Director General
Health Products and Food Branch Inspectorate

Appendix

The following sections of Canadian Good Manufacturing Practices that must be covered during an audit for the sterilization of primary packaging materials :

Section
Regulation
1. Premises
C.02.004
2. Equipment
C.02.005
3. Personnel
C.02.006
4. Sanitation
C.02.007
 
C.02.008
6. Manufacturing Control Department
C.02.011
 
C.02.012
7. Quality Control
C.02.013
 
C.02.014
 
C.02.015
10. Records
C.02.020
 
C.02.021
 
C.02.022
 
C.02.023
 
C.02.024
13. Sterile Products
C.02.029
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