Demonstrating the Effectiveness of the Quality Systems for An FDA Pre-NDA Approval Inspection

Abstract

While there are many similarities in good manufacturing practice (GMP) inspections worldwide, the Food and Drug Administration (FDA) pre-new drug application (NDA) approval inspection of quality systems is of particular significance in achieving rights to market a drug in the United States. Between NDA submission and receiving approval to market, it is critically important to be prepared at all times for the inspection. The direction the audit may follow is relatively flexible and the key issue around quality is defending and justifying the validity of the raw data and demonstrating that the total system is under control. For both drug substances and products the need for close alignment of the quality systems and strong evidence for successful transfer of both control methods and technology is essential. Once it is established that the basic systems are in place the most difficult area of the audit remains the review of the raw data trail. Some key approaches to these issues which finally establish the credibility of the organization being inspected will be explored.