By Chris Smith

Published in: The FDA Group

Published on: January 18, 2022

Abstract: - The FDA conducts Pre-approval Inspections to assure that a manufacturing site named in a drug application can manufacture the product and that the data submitted in the application is complete and accurate. - The PAI has three stated objectives: 1) Readiness for Commercial Manufacturing; 2) Conformance to Application, and 3) Data Integrity Audit - A Mock PAI planned and executed by a knowledgeable and experienced auditing professional is a critically important assurance activity. Following this assessment, any findings that require attention should be remediated through a diligent remediation project. - As part of any preparation plan, companies should designate a readiness team, identify and work with subject matter experts who will be involved, and ready their facility to receive regulators. Key Words: Mock, Objective, Integrity

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