VB-GL-3.28: Requirements for personnel involved in the manufacturing, testing, and importation of veterinary biologics

On this page

  1. Introduction
  2. General requirements
  3. Contact information

1. Introduction

The purpose of this guideline is to notify manufacturers, testing facilities, and importers of veterinary biologics (VB) of the requirements for personnel involved in the manufacturing, testing, and importation of veterinary biologics.

Legal authority

The Canadian Health of Animals Regulations (Part XI - Veterinary Biologics - Section 128.(1) and Section 128.(2)) requires that persons employed in a licensed veterinary biologic establishment are qualified to perform the task assigned to them and holders of a licence issued under these regulations are required to inform the Minister of any change or addition to the material or information originally submitted for the purpose of obtaining the licence.

Health of Animals Regulations, Part XI

2. General requirements

  • VB manufacturers, testing facilities, and importers are required to:
    • Designate a person to act as their official regulatory liaison
      • Designate at least 1 alternate regulatory liaison
    • Ensure that all personnel are qualified for their duties, and have completed pertinent and satisfactory academic, technical and other training for their positions
    • Ensure that all employees are adequately supervised
    • Ensure that all employees have adequate authority to carry out their duties
    • Designate qualified personnel to act as alternates, carrying out duties and functions of key personnel in their absence
    • Provide initial and continuing training to all personnel relevant to their responsibilities
    • Ensure that all training is provided by qualified personnel
    • Maintain up to date training records for all employees
    • Periodically assess the effectiveness of the training
    • Ensure that training is provided prior to the implementation of new or revised procedures
    • Ensure that consultants and contractors have the necessary qualifications, training and experience
    • Maintain a file of job descriptions and curriculum vitae for all employees
    • Designate a qualified person to act as the institutional biosafety officer for each site
    • VB manufacturers only: Ensure that quality assurance (QA) and quality control (QC) activities and personnel involved in quality assurance (QA) or quality control (QC) function in a manner independent of manufacturing, operations and marketing activities, personnel and decisions
  • Organizational chart
    • VB manufacturers, testing facilities, and importers are required to submit an up to date organizational chart to the Canadian Centre for Veterinary Biologics (CCVB) and Veterinary Biologics Operations (VBO), respectively
    • The organizational chart is to show names, titles and reporting relationships for managerial, supervisory and other key personnel involved in veterinary biologic manufacturing, testing and/or importation (refer to a list of functions under Curriculum vitae)
    • The organizational chart should be appropriately titled, clearly showing the company's name and address, effective date of the chart, and be dated and signed by authorized personnel
    • Job titles should accurately reflect duties and responsibilities, and alternates for key personnel should be identified
    • Changes to the organization chart must be filed promptly
      • There is no fee for this service
  • Curriculum vitae
    • VB manufacturers and testing facilities are required to maintain on file a short (1 to 2 pages) curriculum vitae for managerial and supervisory personnel responsible for 1 or more of the following functions, for those positions that are applicable to their circumstances:
      • Regulatory contact and alternate(s)
      • Seeds and cells
      • Product manufacturing
      • Filling and final production
      • Quality assurance / Quality control testing (including serial release)
      • Animal acquisition, care, use and disposal
      • Pharmacovigilance, suspected adverse events
      • Technical support
    • The curriculum vitae should be limited to pertinent academic training, relevant technical training, and relevant experience
      • It should not include personal information (for example, home address, personal telephone numbers, marital status, social insurance number)
    • For United States (U.S.) based VB manufacturers (including U.S. permittees who import products from other countries for distribution and sale in the U.S. and in Canada), copies of the USDA-APHIS Form 2007 , Qualifications of Supervisory Personnel are acceptable
  • Personnel documents from foreign VB manufacturers in languages other than English or French must be accompanied by certified translations
  • All filed personnel information for VB manufacturers must be kept up to date in the CCVB office in Ottawa
    • Filed personnel information for VB importers must be kept up to date in the files of the veterinary biologics operations (VBO) veterinary inspector responsible for their establishment
  • The CCVB and VBO will monitor compliance through regular onsite inspections of Canadian VB licence holders and periodic onsite inspections of foreign VB manufacturers
  • Manufacturers, testing facilities, and importers should periodically conduct internal audits of human resources activities and employee training as part of an ongoing total quality management program
  • The confidentiality of personnel information collected by CFIA will be maintained in accordance with the provisions of the Privacy Act

3. Contact information

Any further questions or clarifications regarding the regulations and requirements pertaining to personnel requirements may be directed to the Canadian Centre for Veterinary Biologics.

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