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

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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

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:

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

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:

3. Related guidelines

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

Memorandum

[Date]
To: [Manufacturer name and address]
From: [Importer name and address]
Subject: List of serials eligible for importation under the [importer-manufacturer company names] permit to import veterinary biologics


This will confirm that I have reviewed the test results for the product serial(s) listed below, and verified that they conform with the testing requirements and permit conditions as described on the current permit to import veterinary biologics.

A copy of this memorandum must accompany the shipment. It will be retained on file at [Importer name].

  1. [CCVB file number] [USDA product code (PCN)]
    [Assigned name] [trade name];
    [Serial Number]; [Expiration date - yyyy-mm-dd]
    [Serial Number]; [Expiration date - yyyy-mm-dd]

  2. [CCVB file number] [USDA product code (PCN)]
    [Assigned name] [trade name];
    [Serial Number]; [Expiration date - yyyy-mm-dd]
    [Serial Number]; [Expiration date - yyyy-mm-dd]

[Signature, importer's authorized representative] [Date]
[Name, importer's authorized representative]
[Position]
[Importer company name]

Date modified: