GOOD MANUFACTURING PRACTICES COMPLIANCE AND PREPARING FOR FDA AUDITS

Abstract

This project evaluates the impact of conducting internal audits within a Quality Control (QC) laboratory. Products tested in the QC laboratory are required to comply with current Good Manufacturing Practices (cGMP) as set forth by the Food and Drug Administration (FDA). By routinely conducting internal audits, companies can identify and correct potential FDA violations prior to an FDA inspection. At a biological manufacturing facility, over a period of five months, internal audits were carried out using a checklist as guidance for observing potential areas for quality and compliance improvement. It was found that by increasing employee awareness of upcoming internal audits in combination with bringing audit observations to the management level, potential improvement opportunities were taken seriously and corrective actions were implemented.