Veterinary Biologics Guideline 3.28E
Guideline for Personnel Requirements

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Introduction

The purpose of this guideline is to notify manufacturers and importers of veterinary biologics of the requirements for personnel involved in the manufacturing and importation of veterinary biologics.

Legal Authority

Health of Animals Regulations, Part XI

128.(1)
No person shall prepare, manufacture, preserve, pack, label, store or test a veterinary biologic in a licensed establishment unless (m) every person employed therein is qualified to perform the task assigned to him.

128.(2)
Every holder of a licence issued under these Regulations shall forthwith inform the Minister of any change or addition to the material or information furnished to the Minister for the purpose of obtaining the licence.

Guidance

A. Manufacturers and importers are required to:

  1. Designate a person to act as their official regulatory liaison. One alternate liaison may also be designated.
  2. Ensure that all personnel are qualified for their duties, and have completed pertinent and satisfactory academic, technical and other training for their positions.
  3. Ensure that all employees are adequately supervised.
  4. Ensure that all employees have adequate authority to carry out their duties.
  5. Designate qualified personnel to act as alternates, carrying out duties and functions of key personnel in their absence.
  6. Provide initial and continuing training to all personnel relevant to their responsibilities.
  7. Ensure that all training is provided by qualified personnel.
  8. Maintain up to date training records for all employees.
  9. Periodically assess the effectiveness of the training.
  10. Ensure that training is provided prior to the implementation of new or revised procedures.
  11. Ensure that consultants and contractors have the necessary qualifications, training and experience.
  12. Maintain a file of job descriptions and curriculum vitae for all employees.
  13. Designate a qualified person to act as the institutional biosafety officer for each site.
  14. (Manufacturers only) Ensure that manufacturing activities and personnel involved in manufacturing are independent from quality assurance (QA) /quality control (QC) activities and personnel involved in QA/QC.

B. Organizational Chart

  1. Manufacturers 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.
  2. The organizational chart is to show names, titles and reporting relationships for managerial, and supervisory and other key personnel involved in veterinary biologic manufacturing and/or importation. (Refer to a list of functions in C.1. below).
  3. 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.
  4. Job titles should accurately reflect duties and responsibilities, and alternates for key personnel should be identified.

C. Curriculum vitae

  1. The manufacturer is required to submit a short (1-2 pages) curriculum vitae for managerial and supervisory personnel who are responsible for one or more of the following functions (Note: Importers are required to submit curriculum vitae for those positions that are applicable to their circumstances):
    1. Regulatory contact and alternate(s)
    2. Seeds and cells
    3. Product manufacturing
    4. Filling and final production
    5. Quality Assurance / Quality control testing (including serial release)
    6. Animal acquisition, care, use and disposal
    7. Technical support and suspected adverse events
  2. The curriculum vitae should be limited to pertinent academic training, relevant technical training, and relevant experience. It should not include personal information (e.g. home address, personal telephone numbers, marital status, social insurance number).
  3. Similar documents may be provided for key research and development personnel, however this is not essential.
  4. For United States (U.S.) based 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.

D. Personnel documents from foreign manufacturers in languages other than English or French must be accompanied by certified translations.

E. All filed personnel information for Canadian and foreign manufacturers must be kept up to date in the CCVB office in Ottawa. Filed personnel information for importers must be kept up to date in the files of the VBO veterinary inspector responsible for their establishment.

F. Any changes or additions to the personnel documents must be filed promptly. There is no fee for this service.

G. The CCVB and VBO will monitor compliance through regular onsite inspections of Canadian licensees and periodic onsite inspections of foreign licensees.

H. Manufacturers and importers should periodically conduct internal inspections as part of an ongoing total quality management program.

I. The confidentiality of personnel information collected by CFIA will be maintained in accordance with the provisions of the Privacy Act.

For further 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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