Title 9

PART 431

Part 431 - Thermally Processed, Commercially Sterile Products

PART 431 - THERMALLY PROCESSED, COMMERCIALLY STERILE PRODUCTS Authority:7 U.S.C. 1633, 1901-1906; 21 U.S.C. 451-472, 601-695; 7 CFR 2.18, 2.53. Source:83 FR 25308, May 31, 2018, unless otherwise noted.

9:2.0.2.4.46.0.69.1SECTION 431.1
   431.1 Definitions.
9:2.0.2.4.46.0.69.2SECTION 431.2
   431.2 Containers and closures.
9:2.0.2.4.46.0.69.3SECTION 431.3
   431.3 Thermal processing.
9:2.0.2.4.46.0.69.4SECTION 431.4
   431.4 Critical factors and the application of the process schedule.
9:2.0.2.4.46.0.69.5SECTION 431.5
   431.5 Operations in the thermal processing area.
9:2.0.2.4.46.0.69.6SECTION 431.6
   431.6 Equipment and procedures for heat processing systems.
9:2.0.2.4.46.0.69.7SECTION 431.7
   431.7 Processing and production records.
9:2.0.2.4.46.0.69.8SECTION 431.8
   431.8 Record review and maintenance.
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   431.9 Deviations in processing.
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   431.10 Finished product inspection.
9:2.0.2.4.46.0.69.11SECTION 431.11
   431.11 Personnel and training.
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   431.12 Recall procedure.