VB-GL-3.31: Pseudorabies virus exclusion testing of veterinary biologics

On this page

• 1. Introduction
  • 1.1 Legal authority
• 2. Guidance
  • 2.1 Testing requirements
  • 2.2 Conditions for a waiver of testing requirements
• 3. Related guidelines
• 4. Contact information
• 5. Memorandum template

1. Introduction

To prevent the introduction of pseudorabies virus into Canada through veterinary biologics (VB), the Canadian Centre for Veterinary Biologics (CCVB), requires that manufacturers conduct a pseudorabies virus exclusion test on all live virus porcine vaccines which utilize porcine serum, or are grown on primary porcine cells. Other products such as live bacterial vaccines intended for use in porcines will require pseudorabies virus exclusion tests, if significant quantities of porcine serum are used in the manufacturing process.

1.1 Legal authority

• Health of Animals Act
• Health of Animals Regulations

2. Guidance

2.1 Testing requirements

For live vaccines, which are intended for use in porcines and are produced using either non-irradiated porcine serum or primary porcine cells, manufacturers are required to conduct pseudorabies exclusion testing. Tests may be carried out on raw materials or on finished serials as described below. The test option and test method must be pre-approved by CCVB.

Option 1 - Testing of raw material of porcine origin which is not subjected to a sterilization process:

• Test all porcine serum used at the premises, whether used in production, quality control or research
• Test all seeds and all primary porcine cells used at the premises
• Utilize satisfactory in-process controls to prevent pseudorabies contamination during manufacture
• Document the test procedure in the Outline of Production for each product

Option 2 - Testing of each serial of the final product:

• The laboratory's test results must be reviewed and signed off by the importing company's authorized regulatory official
• A signed memorandum (see memorandum template), must accompany each shipment being imported into Canada
• Documents must be retained on file by the importing company

2.2 Conditions for a waiver of testing requirements

The pseudorabies exclusion testing may be waived if all of the following conditions are met and are documented in the Outline of Production:

• Either porcine serum is not used in the manufacture of the vaccine, or all of the porcine serum used at the manufacturing facility is gamma irradiated
  • The recognized level of treatment is not less than 20 kiloGray of gamma radiation of the frozen (-20°C) serum
• Primary porcine cells are not used in the manufacture of the vaccine
  • Only established cell lines or non-porcine primary cells are used
• All master seeds and master cell stocks have been tested for pseudorabies with negative results

3. Related guidelines

• VB-GL-3.1: Preparation of new product licensing (registration) submissions for veterinary biologics
• VB-GL-3.22: Master seed stocks, master cell stocks and serial requirements

4. Contact information

Any further questions or clarification regarding the regulations and requirements pertaining to pseudorabies exclusion testing of VB may be directed to the CCVB.

5. Memorandum template