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Veterinary Biologics Guideline 3.24E

Guidelines for Inspection of Veterinary Biologics Importers

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

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 Veterinary Biologics Section 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 the Internet at the following web site at the Universal Resource Locator (URL): http://www.inspection.gc.ca .

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 Veterinary Biologics Section (VBS) 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, VBS. A copy of the INSPECTION REPORT, INSPECTION NOTES and INSPECTION WORKSHEET (if used) will be retained in the Veterinary Biologics Section 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 Veterinary Biologics Section (VBS) staff. The worksheet would ordinarily be retained in VBS 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 VBS 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 VBS staff.
Inspectors should prepare their INSPECTION REPORT using the above template.

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

• VBS will coordinate the inspection dates with the regions by providing a list of Canadian importers prior to the beginning of each fiscal year, so that Regional Inspectors can plan for the inspection and project the activity in their work/project plans.
• Regional inspectors must provide tentative dates for the inspection to VBS.
• VBS will notify importer, by letter, of the inspection date, name of inspector and the estimated amount of fees that would be charged, with a copy to regional inspector. Note - an estimate of regional inspector's travel expenses will be included as this is subject to cost recovery.
• Regional inspector to handle own travel authority request. Upon receipt of final expense claim amount, a copy is to be faxed to VBS in order to finalize and reconcile the cost recovery fees.
• VBS will send copies of the import permit(s) and identify specific items that need to be addressed by the inspector during the inspection, at least two weeks prior to the inspection.
• The completed INSPECTION REPORT and INSPECTION NOTES should be signed by the inspector(s) and forwarded to the VBS within 10 working days after the inspection.
• The inspection report, under a covering letter signed by the National Manager, will be forwarded to the importer, and also copied to the Regional Inspector.
• A copy of the INSPECTION REPORT, INSPECTION NOTES and INSPECTION WORKSHEET (if used) will be retained in the Veterinary Biologics Section importer file.

IV. REFERENCES

• Health of Animals Act
• Health of Animals Regulations
• Public Health Agency of Canada Laboratory Biosafety Guidelines
• Canadian Food Inspection Agency Containment Standards for Veterinary Facilities
• Canadian Council on Animal Care Guide for the Care and Use of Experimental Animals
• Canadian Food Inspection Agency Recommended Codes of Practice for the Care and Handling of Farm Animals

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 VBS.

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 VBS. 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.

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 Veterinary Biologics Section issues establishment licences, product licences and import permits to regulate the manufacturing, importation, distribution, and sale of veterinary biologics in Canada. VBS 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.

• Veterinary Biologics Establishment Licence
• Veterinary Biologics Product Licence(s)
• Permit To Import Veterinary Biologics Into Canada

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. VBS 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)

• Authorizes production of registered products or autogenous vaccines.
• Registered products must be produced in licensed establishment; using appropriate control measures to ensure isolation of commercial products from facilities used for research, diagnostic, quality assurance testing, and autogenous vaccine production.
• Verify name of regulatory liaison. Prefer to have one regulatory liaison, and one alternate regulatory liaison in case regulatory liaison is unavailable.
• Verify company name, address, telephone, facsimile, regulatory contact(s), issue date, expiry date. Establishment license address should note location of each licensed manufacturing facility, which may be different from manufacturer's headquarters mailing address. If more than one manufacturing facility is used, then each site should have an establishment license.
• Discuss difference in requirements for establishment licences for production of conventional registered products versus autogenous vaccines.
• Establishments used for production of commercial products must be separated from facility for autogenous products. If a manufacturer producers both registered products and autogenous vaccines, personnel, facilities, equipment, reagents, and products must be kept separate.
• Manufacturer must maintain a log of all infectious agents in inventory for production of autogenous vaccines, noting source of isolate, identity of culture, date of accession, name, address, species.
• Manufacturer must maintain a production outline for all autogenous veterinary biologics, and must conduct appropriate quality assurance tests to verify safety. Generic outlines of production must be submitted for approval. Detailed procedures are not required, and samples are not submitted to BEL for confirmatory testing.
• Renewal of licences and import permits is dependent on compliance with Health of Animals Act and Regulations, and conditions specified on licences and permits. VBS may audit compliance by conducting inspection or requesting that manufacturer/importer file an interim inspection report based on an internal evaluation conducted by company representatives.
• See sample Veterinary Biologics Establishment Licence.

12.1 (b) Veterinary Biologics Product Licence

• Licence issued for each veterinary biologic manufactured in Canadian establishment.
• Verify accuracy of product assigned names, trade names, VBS file numbers.
• Note products with special conditions restricting use.
• Verify that all products are currently in production. Recommend deleting inactive products.
• See sample Veterinary Biologics Product Licence.

12.1 (c) Permit To Import Veterinary Biologics Into Canada

• For importation of veterinary biologics for commercial distribution or investigational use.
• Verify accuracy of company name, address, telephone, facsimile, regulatory contacts.
• Verify accuracy of product assigned names, trade names, VBS file numbers, USDA-APHIS codes.
• Verify that all products are currently being imported. Recommend deleting inactive products.
• All imported veterinary biologics must be registered for use in country of origin.
• See sample 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.

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.

• Verify accuracy of plot plans, blue prints, legends.
• Verify that all essential equipment is operational.
• Responsibility, signing authority, in-process controls, validation.
• Verify that equipment is monitored regularly.
• Note dates of servicing for laminar flow hoods, autoclaves, etc.
• Note manual versus automatic controls.
• Review records for equipment checks (freezers, laminar flow hoods, incubators).
• Equipment accurately and uniquely identified.
• Equipment located according to blueprint & legends.
• Automatically controlled equipment (autoclaves & dry heat sterilizers).
• Observe equipment in operation.
• Examine maintenance, service, calibration, and repair logs.

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

• Responsibility, signing authority.
• Reporting relationships.

12.5 (b) Facilities

• General appearance of premises.
• Cooler space adequate.

12.5 (c) Equipment

12.5 (d) Documents & Records

• Inventory records.
• Records (receiving, shipping, inventory, returns, disposal).

12.5 (e) Operations

• Distribution Records.
  • How are estimates and actual inventories reconciled?
  • Are distribution records adequate for inventory control, recalls.
  • Could a total stop sale or recall be carried out by the firm if necessary?
  • Recall of product.
  • Serial number shown on invoice.
  • Procedure for investigation of complaints.
  • Transported under refrigeration.
  • Method of reconciling estimates to actual sales doses.
  • To ensure that the distribution system and records are appropriate for inventory control and tracing sales and tracking system would enable a product recall if required.
  • Capability for stop sale or recall product to user level.
  • Adherence to license restrictions (e.g. rabies vaccines to be sold to veterinarians only).

• Inventory control

  • Review the firm's stop sale policy to be sure that is in accordance with VBS requirements.
  • Review documentation of any recent product recalls or stop sale to determine if actions taken were appropriate and in accordance with VBS policy and guidelines.

• Disposal of outdated product

  • Extension of dating records.
  • No unsold product returned to inventory.
  • Method of reconciling estimates to actual doses.

• Product Recalls

  • Evaluate the physical system of control and identification on pre- and post- release serials.
  • The serial tracking system should prevent inadvertent distribution of unreleased serials.
  • Watch for signs of premature shipment of serials before actual release date.

• Product Storage and Inventory Records

  • Check to see if cooler space is adequate for licensed products at the normal level of production.
  • Check system for handling returned goods on premises.
  • Check records for returned goods.

• Imported product

  • Ports of entry used.
  • Average/maximum time in transit.

• Return policy

  • Returned goods handling, storage to ensure they are not returned to inventory.
  • Computer database and hard copy of distribution records

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 VBS requirements for reporting adverse reactions (Guidelines attached). Verify that appropriate technical support is provided. Adverse reactions must be investigated and reported to VBS within 15 days.

12.6 (a) Personnel

• Responsibility, signing authority for adverse reaction investigations.
• Reporting relationships, mechanism for relaying consumer complaints.
• Veterinary consultation available.

12.6 (b) Facilities

• Office space, records storage.

12.6 (c) Equipment

• Telephone number for adverse reaction complaints.
• Telephone answering system.
• Computer database or manual records for recording adverse reactions.

12.6 (d) Documents & Records

• VBS adverse reaction reporting forms.
• Adverse reaction logs.

12.6 (e) Operations

• Review the firm's stop sale policy to be sure that is in accordance with VBS requirements.
• Review documentation of any recent product recalls or stop sale to determine if actions taken were appropriate and in accordance with VBS policy and guidelines.
• Adherence to licence restrictions.
• Protocol for recording complaints and initiating investigations. Follow-up.
• Capability for stop sale/recall to user level.
• Sales representatives should advise customers about the procedure for reporting adverse reactions, and provide copies of VBS adverse reaction reporting form, which may be supplemented by company forms.
• Standard policy for handling complaints, call-backs.
• Review recent on-farm investigations.

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.

	SATISFACTORY Facility in compliance with Health of Animals Act and Regulations.
		No significant deficiencies noted.
		No significant deficiencies noted. A few minor operational deficiencies observed in non-critical areas which do not affect safety or product quality, but will require ongoing attention to ensure continued compliance.
		No significant deficiencies noted. Minor operational deficiencies in non-critical areas which do not affect safety or product quality, but will require immediate correction to ensure continued compliance.
	UNSATISFACTORY Facility not in compliance with Health of Animals Act and Regulations.
		Product Quality Significant deficiencies noted in critical areas which could potentially affect product quality (purity, potency, safety, efficacy) and will require immediate correction to ensure compliance.
		Laboratory Biosafety. Significant deficiencies in compliance with laboratory biosafety guidelines. - Public Health Agency of Canada Laboratory Biosafety Guidelines. - Canadian Food Inspection Agency Containment Standards for Veterinary Facilities.
		Animal Care Significant deficiencies in compliance with animal care guidelines. - Guide for the Care and Use of Experimental Animals. - Recommended Codes of Practice for the Care and Handling of Farm Animals.
		Environment Significant deficiencies in compliance with regulations under the Health of Animals Act, or other federal or provincial legislation.
		Other Describe other reasons why facility is not in compliance with the Health of Animals Act and Regulations.
	OTHER Compliance status not assessed. Explain reasons.

Inspector Signature: ______________________________

Name, Organization, Date: __________________________

Version:  VBGL03.24E.01