subchapter_subject: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_code: "507"
part_subject: "CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR FOOD FOR ANIMALS"
subpart_code: "C"
subpart_subject: "Hazard Analysis and Risk-Based Preventive Controls"
section_number: "507.47"
section_subject: "Validation."
cfr_reference: "21 CFR 507.47"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 500 to 599"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(a)You must validate that the preventive controls identified and implemented in accordance with § 507.34 are adequate to control the hazard as appropriate to the nature of the preventive control and its role in the facility's food safety system.
(A)Prior to implementation of the food safety plan; or
(B)When necessary to demonstrate the control measures can be implemented as designed:
(1)Within 90 calendar days after production of the applicable animal food first begins; or
(2)Within a reasonable timeframe, provided that the preventive controls qualified individual prepares (or oversees the preparation of) a written justification for a timeframe that exceeds 90 calendar days after production of the applicable animal food first begins;
(ii)Whenever a change to a control measure or combination of control measures could impact whether the control measure or combination of control measures, when properly implemented, will effectively control the hazards; and
(iii)Whenever a reanalysis of the food safety plan reveals the need to do so.
(2)Must include obtaining and evaluating scientific and technical evidence (or, when such evidence is not available or is inadequate, conducting studies) to determine whether the preventive controls, when properly implemented, will effectively control the hazards.
(3)The supply-chain program in subpart E of this part; and
(4)Other preventive controls, if the preventive controls qualified individual prepares (or oversees the preparation of) a written justification that validation is not applicable based on factors such as the nature of the hazard, and the nature of the preventive control and its role in the facility's food safety system.