ABSTRACT
The purpose of an FDA PAI (U.S. Food and Drug Administration preapproval in spection) is to ensure that product development is sound, justifies the process attribute ranges, and states how and why the proposed commercial process was developed. It ensures that there is no fraud and that the manufacturing process and testing procedures are up to today's GMP (Good Manufacturing Practice) standards. This includes making sure that the GMP systems present at the
clinical development and commercial manufacturing facility are up to today's GMP standards. The program described in this chapter consists of auditing early in the clinical development and commercial manufacturing process as the docu ments are being developed to support the application and validation of the com mercial manufacturing process. Regular follow-up audits are conducted to ensure that all documents and systems will be within compliance prior to the FDA PAI.
