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