Good Manufacturing Practice (GMP) Audits

IEH staff can conduct complete GMP audits of food processing or pharmaceutical manufacturing plants. Adherence to good GMPs is critically important for al food or pharmaceutical manufacturers to produce wholesome and safe products and to meet FDA and USDA/FSIS regulations.

During an audit, IEH will thoroughly review the food or pharmaceutical process operations focusing on raw materials and ingredients handling, batching, processing, packaging, and warehousing, as well as record keeping. During all production phases, IEH will look at possible opportunities for product contamination or adulteration, with careful attention to plant sanitation practices, equipment design, regulatory requirements, packaging procedures, quality assurance testing procedures, records, validation steps and product distribution records and controls. IEH will also look at product production flow patterns to minimize the chances that product could bypass process operations.

After completion of the audit, IEH will issue a detailed report with comments and recommendations. After issuing the audit report, IEH will contact the client for further discussion.