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.