Title 9, Part 431 — Thermally Processed, Commercially Sterile Products
12 sections
Section 431.1
Definitions.
Section 431.2
Containers and closures.
Section 431.3
Thermal processing.
Section 431.4
Critical factors and the application of the process schedule.
Section 431.5
Operations in the thermal processing area.
Section 431.6
Equipment and procedures for heat processing systems.
Section 431.7
Processing and production records.
Section 431.8
Record review and maintenance.
Section 431.9
Deviations in processing.
Section 431.10
Finished product inspection.
Section 431.11
Personnel and training.
Section 431.12
Recall procedure.