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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2016.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2016]
[CITE: 21CFR117.145]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION

PART 117 -- CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD

Subpart C--Hazard Analysis and Risk-Based Preventive Controls

Sec. 117.145 Monitoring.

As appropriate to the nature of the preventive control and its role in the facility's food safety system:

(a) Written procedures. You must establish and implement written procedures, including the frequency with which they are to be performed, for monitoring the preventive control; and

(b) Monitoring. You must monitor the preventive controls with adequate frequency to provide assurance that they are consistently performed.

(c) Records. (1) Requirement to document monitoring. You must document the monitoring of preventive controls in accordance with this section in records that are subject to verification in accordance with 117.155(a)(2) and records review in accordance with 117.165(a)(4)(i).

(2) Exception records. (i) Records of refrigeration temperature during storage of 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.

(ii) Exception records may be adequate in circumstances other than monitoring of refrigeration temperature.

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