ABSTRACT
The probability of a pre-approval inspection (PAI) success is significantly decreased if documentation supporting the final product is not complete, accurate, and in compliance with regulatory expectations, current good manufacturing practices, and customer expectations. This chapter examines the establishment of a program designed to monitor the compliance level of operations and leading to preparation for the PAI. Preparation for a PAI is a continuous process as new products enter the development program and are ultimately transferred from clinical production to the commercial facility. Global management can achieve collaboration between company sites in preparation for the PAIs. The key to the success of the quality assessment program (QAP) is senior management support, including local facility senior management and corporate executive management. The QAP is a team function and therefore it is essential that the conventional misnomer of auditor and auditee be dismissed.
