System Validation Protocol for Computerized Sterilization Control

There is widespread use of computer control including PLC and PC based electronic control of in-container, in-flow low acid canned food (LACF) and refrigerated (chilled) food products. Unfortunately, there appears to have been one documented software failure attributed to the use of these systems which created an unintentional, but potential threat to public health. A product recall resulted. Inadequate system validation by the supplier was determined to be the cause. The LACF Good Manufacturing Practice (CFR Title 21, Parts 108, 113, and 114) regulations, while longstanding since the early 1970's, are silent in areas related to electronic process control systems. They do, however, contain sections which pertain to these control systems (21 CFR 108.35(a) and 21CFR 113.40(j)). New systems must "...be operated or administered in a manner adequate to ensure that commercial sterility is achieved." Regulatory requirements including those addressed in LACF GMP'S, Seafood HACCP and the Proposed Infant Formula GMP's strongly imply or specifically state the mandatory need for the processor to have a written system validation plan where electronic process control is employed. An NCFST developed Guideline would serve the equipment supplier, food processor, and the FDA Investigator as a critical guide to the life cycle development and implementation of computer control systems (software and related hardware) for commercial use with pasteurized or sterilized foods. This project is in the first of two phases. Phase I involves the assembly of critical documents already available within FDA and the industry on system validation protocols and existing requirements. Phase II consists of, with a collective perspective, developing a suitable guideline covering validation protocol, change control, security, re-validation, HACCP verification and prerequisite programs.