Memorandum 2010-03: Growth promotion testing of culture media used in quality control of veterinary biologics
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59 Camelot Drive
Ottawa, Ontario K1A 0Y9
December 21, 2010
Veterinary Biologics Manufacturers and Veterinary Biologics Quality Control Laboratories
The purpose of this memorandum is to clarify the regulatory requirements for growth promotion testing of culture media used in quality control (QC) testing of veterinary biologics.
As part of the process validation, culture media used in QC testing of in-process and finished product samples must be tested for growth promotion abilities. The QC testing includes sterility testing, inactivation testing, purity testing, and any other relevant testing. Each lot of culture medium (obtained commercially or prepared in-house) should be tested for growth promotion abilities prior to its first use. At a minimum, growth promotion testing must include aerobic bacteria, anaerobic bacteria, and fungi. Culture media with long-term expiration dating may require periodic revalidation of growth promotion abilities.
No action is required if the current testing protocol is in compliance with this requirement. Companies not currently complying with this requirement must submit a letter to the Canadian Food Inspection Agency – Canadian Centre for Veterinary Biologics, explaining when and how this requirement will be met. The compliance with this requirement will be verified during on-site facility inspections or renewal of permits and supporting documentation.
If you have any questions or require additional information about the above requirement, please contact our office.
Glen Gifford, DVM, MSc
Canadian Centre for Veterinary Biologics
Terrestrial Animal Health Division
Canadian Food Inspection Agency
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