Process Development Audits

Proper process development is key to producing as safe and wholesome food or pharmaceutical product as possible. IEH staff will thoroughly audit a client’s process development procedures to assure that appropriate process development and design methods are employed.

A process development audit will include an evaluation of all temperature and pressure measuring instruments, and data logger calibrations. Data acquisition software programs, and testing methodologies will also be reviewed. Process simulations and data collection and reduction will be evaluated for appropriateness, as will be the data handling, interpretation, and other calculation procedures. For aseptic systems and fillers, a thorough process development audit will include evaluation of microbial challenge tests, if appropriate. If product rheological properties have been determined to be a process critical factor for an optimized process, IEH will review the tests and methods used to establish any critical values. The required regulatory process filing documents will also be reviewed for completeness and accuracy.

After completion of the audit, IEH will issue a detailed report with comments and recommendations and follow up with a telephone call to discuss questions or other issues.