Are cleaning faults, really, quality or administrative issues?: Cleaning Validation Program optimization for a Pharmaceutical plant

Abstract

The cleaning procedure process validation has generated considerable discussion when executing a US Food and Drug Administration (FDA) inspection at Pharmaceutical Plants. In general, the FDA requires the equipment to be clean prior to its use for manufacturing, processing, packing, holding of a drug product and/ or when sampling a raw material. Currently, some pharmaceutical plants have failed to design a good manual cleaning process. In regards to this, the Management Theory is crucial to manage effectively a cleaning procedure with the optimization of the Cleaning Process Validation. The application of the management functions contributed on the development of a guide to correct these faults and/or prevent further occurrence. By implementing the Administrative Management Theory a cleaning validation program is without a doubt optimized. Key Terms — Administrative Management Theory, Cleaning validation, crucial, optimization