Pre-Approval InspectionsThe FDA's Pre-Approval Inspection (PAI) is a critical time-to-market pre-requisite to getting your new drug product licensed and approved for commercial manufacturing. Unanticipated delays, caused by unfavorable PAI results, can cost millions of dollars.
This white paper offers insight into:
- The criteria used by FDA for deciding whether an inspection is to be conducted for a given application
- The two types of pre-approval inspections performed (Priority and Discretionary)
- The composition of the FDA inspection team
- Pre-PAI readiness assessment focus areas to improve your organization's probability of passing the inspection
- A summary of types of findings or deficiencies that will result in a recommendation to withhold PAI approval
- Special considerations for virtual companies
This white paper will present critical information regarding Pre-Approval Inspection Audits and also demonstrate how a Pre-PAI readiness assessment can maximize the probability of a Life Sciences organization passing an FDA PAI Audit.
If you are interested in learning more about this topic, we also have a recorded webinar entitled "PAI Audits: Are You Ready?" presented by the author of this white paper.
