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Veterinary Biologics Guideline 3.24E
Guidelines for Inspection of Veterinary Biologics Importers

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Table of Contents


I. Overview

A. Inspection Objectives

Primary Objective

The primary objective of facility inspections is to assure that Canadian importers of veterinary biologics meet the requirements of the Health of Animals Act and Regulations with respect to the importation of veterinary biologics for use within Canada and export to other countries.

Specifically, inspections are intended to assess whether importers are in compliance with veterinary biologics licensing requirements, and are conforming with the conditions specified on licences and permits issued under the authority of the Health of Animals Act and Regulations.

Secondary Objectives

  1. To become familiar with the corporate structure, organization of the company and key personnel and note any changes that have occurred since the last inspection.
  2. To become familiar with the physical facilities, equipment, and record keeping, and note any changes that have occurred since the last inspection.
  3. To utilize the opportunity presented by a visit to the company to engage in a two-way dialogue to discuss any problems and provide the importers with information regarding Canadian regulatory requirements and other pertinent information.

B. Inspection Procedures

The time devoted to an inspection may vary from one-half to one day depending upon the size of the company. Canadian importers are inspected on a three to four year cycle. Inspection findings are reinforced by organization charts, blueprints and legends pertaining to facilities and equipment, and résumés of key personnel.

Typical inspections would include the following activities:

  1. Introduction of inspector(s).
  2. Brief meeting with management and key personnel to explain objectives of inspection.
  3. Examination of licences and permits.
  4. Tour of facilities with importer's regulatory liaison.
  5. Wrap-up meeting to review findings and discuss action items.

An inspection report should be prepared and filed shortly after the conclusion of the inspection. The importer should be provided with a copy of the Inspection Report. The Inspection Report should include a summary of major changes since the last inspection including corporate structure, ownership, personnel, facility changes, equipment changes, product line changes, and a summary of the key findings and action items.

Renewal of licences and import permits is dependent on compliance with Health of Animals Act and Regulations, and conditions specified on the licences and permits.

The Canadian Centre for Veterinary Biologics will monitor compliance by periodically conducting onsite inspections. Importers should periodically conduct internal inspections as part of an ongoing total quality management program.

II. Pertinent Legislation And Guidelines

The Health of Animals Act and Regulations state that the Governor in Council may make such regulations and orders as to him seem necessary for any of the following purposes, that is to say for: regulating (i) the importation, preparation, manufacturing, preserving, packing, labelling, storing, testing, transportation and disposal of any veterinary biologics, and (ii) the sale, advertising for sale and conditions of sale of any veterinary biologics.

The following are excerpts from the Health of Animals Regulations pertaining to veterinary biologics These excerpts are provided for use as a reference for inspectors. The full text of the Health of Animals Act and Regulations is available on Government of Canada web sites:

Part XI. 121.(1) No person shall import a veterinary biologic into Canada unless he does so under and, in accordance with, a permit issued by the Minister.

Part XI. 123. No person shall prepare, manufacture, preserve, pack, label or test a veterinary biologic unless he does so under and in accordance with an establishment license issued by the Minister.

Part XI. 124. No person shall manufacture a veterinary biologic unless he does so in accordance with a product licence issued by the Minister.

III. Preparing Inspection Notes And Reports

A. Inspection Guideline and Background Information

The inspection guideline including the background information (Appendix A) is intended to be used by the inspector as a reference for clarifying the inspection objectives and facility requirements when preparing inspection notes and inspection reports.

The completed INSPECTION REPORT and INSPECTION NOTES should be signed by the inspector(s) and forwarded to the Canadian Centre for Veterinary Biologics (CCVB) within 10 working days after the inspection. The completed inspection report will be forwarded to the importer under a covering letter signed by the National Manager, CCVB. A copy of the INSPECTION REPORT, INSPECTION NOTES and INSPECTION WORKSHEET (if used) will be retained in the Canadian Centre for Veterinary Biologics importer file.

B. Inspection Worksheet

During an inspection, inspectors can use the INSPECTION WORKSHEET as a reference when targeting key inspection areas. If the worksheet is used to supplement notes taken during an inspection, then it should be viewed as containing Confidential Business Information and should be protected at all times and only made available to Canadian Centre for Veterinary Biologics (CCVB) staff. The worksheet would ordinarily be retained in CCVB importer files, and used to prepare INSPECTION NOTES and INSPECTION REPORTS.

C. Inspection Notes (see Inspection Notes template attached)

Inspection notes are prepared from information gathered by an inspector(s) during an inspection visit of the importer's facility. Because the notes are likely to contain Confidential Business Information, they should be protected at all times and only made available to CCVB staff.
Inspectors should prepare their INSPECTION NOTES using the above template.

D. Inspection Report (see Inspection Report template attached)

Detailed comments and information gathered in the INSPECTION NOTES are used to prepare a brief INSPECTION REPORT which summarizes the findings and assessments of the inspected facility. When applicable, the INSPECTION REPORT should indicate that further information is recorded in the INSPECTION NOTES. Because the report is likely to contain Confidential Business Information, it should be protected at all times and only made available to CCVB staff.
Inspectors should prepare their INSPECTION REPORT using the above template.

E. Process to be Followed by Inspectors for Conducting an Importer Inspection

IV. References

V. Appendix A - Background Information For Preparing Inspection Notes / Reports

A. COMPANY PROFILE

  1. Company Name
    Note full company name as it appears on licences and permits.
  2. Permit to Import Veterinary Biologics
    Canadian importers are issued a Permit to Import Veterinary Biologics which identifies the importer and manufacturer and lists all licensed products. Imported products must be licenced for use in the country of origin. Examine the import permit and record the number, the date of issuance, and the date of expiry. Compare with the copy of permit provided by CCVB.
  3. Mailing Address
    Note mailing address where the importer's regulatory affairs liaison can be contacted. May be either corporate office or warehouse facility address.
  4. Location of Facility
    Indicate street, city, province.
  5. Inspector(s)
    Indicate name of inspectors conducting inspection and preparing report.
  6. Inspection Date
    Indicate dates when inspection was conducted.
  7. Purpose of Inspection
  8. Previous Inspection(s)
    Note dates of previous inspections by CCVB. Also indicate dates of recent inspections by USDA-APHIS or internal auditors.
  9. Personnel Contacted
    List names of key contacts during inspection. Secondary contacts can be listed under 'Personnel' section of report.
  10. Importing Activities at the Facility
    Indicates a company's involvement in importing activities by placing a checkmark (/) beside Importer (Imp). Provide 'snapshot' information about the size of facility and range of activities.
Vaccine Conventional
Inactivated
Conventional
Live
Recombinant DNA
Inactivated
Recombinant DNA
Live
Bacterial ( ) ( ) ( ) ( )
Viral ( ) ( ) ( ) ( )
Fungal ( ) ( ) ( ) ( )
Mycoplasma ( ) ( ) ( ) ( )
Protozoa ( ) ( ) ( ) ( )
Diagnostic Kit ( )   ( )  
Colostrum ( )      
Plasma, Serum ( )      

Vaccine fractions on premises: Other products and activities (feeds, drugs, pesticides, autogenous vaccines, diagnostic laboratory services, etc.):

B. MAJOR CHANGES SINCE LAST INSPECTION

11. Recent Changes at the Facility
List major changes such as:

11.1 Corporate Changes
11.2 Personnel Changes
11.3 Facility Changes
11.4 Equipment Changes
11.5 Product Changes

C. SUMMARY OBSERVATIONS AND COMMENTS

12. Inspection Findings and Assessment
List major observations and comments for each key component of importing facility.
Examine personnel, facilities, equipment, documents & records, and operations for each key area listed in headings 12.1 to 12.6 below:

12.1 Licences and Permits
12.2 Facilities
12.3 Equipment
12.4 Sanitation & Maintenance
12.5 Distribution, Marketing
12.6 Technical Service

12.1 Licences and Permits

Objective(s)

To confirm accuracy of licences and permits, and verify that importer is operating in accordance with the Health of Animals Act and Regulations, and conditions specified in current licences and permits.

Pertinent Regulations

Health of Animals Act and Regulations Part XI. 123 & 124.

Background Information and General Inspection Guidelines

The Canadian Centre for Veterinary Biologics issues establishment licences, product licences and import permits to regulate the manufacturing, importation, distribution, and sale of veterinary biologics in Canada. CCVB also regulates importation of infectious agents, serum, and material of animal/microbial origin for use in research and diagnostic laboratories. These research materials are not subject to the same restrictions as commercial veterinary biologics which are used for treatment, diagnosis or prevention of infectious diseases in animals.

Veterinary biologics manufacturers and importers would ordinarily be issued some, or all, of the following permits or licences.

The Veterinary Biologics Establishment Licence and the Permit(s)To Import Veterinary Biologics Into Canada are issued for 'licensed' products which are intended for commercial distribution and sale in Canada.

Renewal of licences and import permits is dependent on compliance with Health of Animals Act and Regulations, and conditions specified on the licences and permits. CCVB monitors compliance by periodically conducting onsite inspections. Importers should periodically conduct internal inspections as part of an ongoing total quality management program.

Copies of the importer's current licences and permits should be attached to the inspection notes, and checked for accuracy against the importer's copy of the licence or permit. Examine all veterinary biologics licences and permits. Also examine other federal, provincial, municipal licenses, permits, and documents. Evaluate compliance with conditions on permits for importation of licensed products or organisms for research and evaluation. Materials imported under research permits must be kept separate from facilities where licensed products are stored.

12.1 (a) Veterinary Biologics Establishment Licence ( for licensed manufacturers)

12.1 (b) Veterinary Biologics Product Licence

12.1 (c) Permit To Import Veterinary Biologics Into Canada

12.2 Facilities

Objective(s)

To verify that facilities are suitable for the intended purpose and in compliance with the Health of Animals Act and Regulations.

Pertinent Regulations

Health of Animals Act and Regulations Part XI. 128 (1).

Inspection

Examine facilities and compare with documents (plot plans, blueprints, legends) to ensure that facilities are appropriate for storage of veterinary biologics. Verify facilities conform with plot plan, blueprint, legends. Traffic flow. Adequacy of space. lights, heating, cooling, ventilation, hot/cold water, drainage.

Plot Plan

A 'Plot Plan' is a scale drawing of the premises. The plot plan should be entitled 'Plot Plan' and indicate the company name, address, date, and name of person who prepared the plot plan. The plot plan should indicate the location of each building and other structure on the property, and show the location of boundaries and identifying adjacent properties. The buildings should be numbered on the plot plan, and each numbered building should be assigned a descriptive name on a list beside the drawing. The scale, key dimensions, and directions should be provided. The plot plan drawing may be submitted in the original architect's large scale format, or reduced to fit on 8.5 x 11 paper.

Company Name
Page 1
October 5, 1997
Establishment Licence Number
 
Supersedes May 2, 1996

Prepared by:

Approved by:

Blue Prints

A 'blue print' is a scale drawing of the building, showing the floor plan and location of key equipment.

Blue prints and plot plans should be accompanied by legends describing the construction and use of the facility. Each room must be identified by a unique number which should be posted over the entrance into the room. All stationary equipment used in the storage of veterinary biologics must be uniquely numbered, and indicated on the blue print. For each room, the blue print legend should describe the physical construction of the room, and indicate the function, construction, fractions, cleaning and disinfection. These plot plans should show the location of the facilities on the property, and indicate the location of all outdoor structures such as access roads, perimeter fences, buildings, parking areas, loading docks, and animal holding pens.

Plot Plan Legend

Street Address, City, Province
Briefly describe the premises (dimensions, perimeter fences, roadways, parking areas, number of buildings, ground cover and adjacent property).

Building 1
Description:
(Briefly describe each building by providing information about dimensions, building type, construction materials, water supply, drainage, ventilation, heating, cooling, and lighting.)

Use:
(Briefly describe main use for each building, as well as all other uses.)

Building 2
Description:
Use:

Blue Print Legends

The 'blue print legend' lists the function or use of each room within the facility. It describes the function, product components used in each room. It also identifies the equipment, and clean-up procedures. The legends would provide a list of rooms and for each room the functions, fractions, equipment, clean-up procedures.

12.3 Equipment

Objective(s)

To verify that all equipment is functional, suitable for the intended purpose, and in compliance with the Health of Animals Act and Regulations.

Pertinent Regulations

Health of Animals Act and Regulations Part XI. 128 (1).

Inspection

Verify equipment installed conforms with blueprint, legends. Review maintenance and validation records. Examine records for automatically controlled equipment. Examine operating logs. All equipment must be uniquely identified. Laboratory biosafety.

12.4 Sanitation & Maintenance

Objective(s)

To verify that compliance with the Health of Animals Act and Regulations, and staff are using appropriate sanitation, biocontainment, and maintenance practices in order to minimize the likelihood of contamination of product, accidental exposure of personnel, or contamination of the environment.

Pertinent Regulations

Health of Animals Act and Regulations Part XI. 128 (1).

Inspection

Verify that sanitation protocols are established. Outside drainage, debris removal. Vermin control. Appropriate disposal of biological wastes. Sewage.

12.5 Distribution and Marketing

Objective(s)

To verify that the establishment's product storage and distribution practices are in accordance with the Health of Animals Act and Regulations.

Pertinent Regulations

Health of Animals Act and Regulations Part XI. 129 (1-2).

Inspection

Signing authority, validation. Serial numbers, expiration dates. Secure storage, inventory log. Cooler space. Transportation to distributors/clients.. Handling and disposal of returned product. Disposal of outdated inventory.

12.5 (a) Personnel

12.5 (b) Facilities

12.5 (c) Equipment

12.5 (d) Documents & Records

12.5 (e) Operations

12.6 Technical Service

Objective(s)

To verify that the establishment's technical service practices are in accordance with the Health of Animals Act and Regulations.

Pertinent Regulations

Health of Animals Act and Regulations Part XI. 129 (1-2).

Inspection

Product complaint logs. Adverse reaction reports. Review CCVB requirements for reporting adverse reactions (Guidelines attached). Verify that appropriate technical support is provided. Adverse reactions must be investigated and reported to CCVB within 15 days.

12.6 (a) Personnel

12.6 (b) Facilities

12.6 (c) Equipment

12.6 (d) Documents & Records

12.6 (e) Operations

VI. Assessment

13. Overall Assessment

The inspector's overall evaluation of facility's compliance with Health of Animals Act and Regulations. Place checkmark (/) beside the appropriate assessment (Satisfactory, Unsatisfactory, or Other) and sub-heading.

Inspector Signature:

Name, Organization, Date:

Date modified: