Code of Federal Regulations (Last Updated: May 6, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter E - Animal Drugs, Feeds, and Related Products |
Part 507 - Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals |
Subpart C - Hazard Analysis and Risk-Based Preventive Controls |
§ 507.40 - Monitoring.
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§ 507.40 Monitoring.
As appropriate to the nature of the preventive control and its role in the facility's food safety system you must:
(a) Establish and implement written procedures, including the frequency with which they are to be performed, for monitoring the preventive controls; and
(b) Monitor the preventive controls with adequate frequency to provide assurance that they are consistently performed.
(c)
(1) You must document the monitoring of preventive controls in accordance with this section in records that are subject to verification in accordance with § 507.45(a)(2) and records review in accordance with § 507.49(a)(4)(i);
(2)
(i) Records of refrigeration temperature during storage of animal food that requires time/temperature control to significantly minimize or prevent the growth of, or toxin production by, pathogens may be affirmative records demonstrating temperature is controlled or exception records demonstrating loss of temperature control; and
(ii) Exception records may be adequate in circumstances other than monitoring of refrigeration temperature.