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.

• 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.

9:2.0.2.4.46.0.69.1	SECTION 431.1	431.1 Definitions.
9:2.0.2.4.46.0.69.2	SECTION 431.2	431.2 Containers and closures.
9:2.0.2.4.46.0.69.3	SECTION 431.3	431.3 Thermal processing.
9:2.0.2.4.46.0.69.4	SECTION 431.4	431.4 Critical factors and the application of the process schedule.
9:2.0.2.4.46.0.69.5	SECTION 431.5	431.5 Operations in the thermal processing area.
9:2.0.2.4.46.0.69.6	SECTION 431.6	431.6 Equipment and procedures for heat processing systems.
9:2.0.2.4.46.0.69.7	SECTION 431.7	431.7 Processing and production records.
9:2.0.2.4.46.0.69.8	SECTION 431.8	431.8 Record review and maintenance.
9:2.0.2.4.46.0.69.9	SECTION 431.9	431.9 Deviations in processing.
9:2.0.2.4.46.0.69.10	SECTION 431.10	431.10 Finished product inspection.
9:2.0.2.4.46.0.69.11	SECTION 431.11	431.11 Personnel and training.
9:2.0.2.4.46.0.69.12	SECTION 431.12	431.12 Recall procedure.

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