Pre-Approval Inspection (PAI) ensures that a manufacturer can manufacture and/or test a drug and that the submitted data are accurate and complete. Mock-PAIs are conducted to determine if there are any items related to the areas of focus by the FDA that need to be corrected or improved before an official PAI is conducted. A final report is generated that details and prioritizes the findings of the mock inspection.
Being ready for a PAI is an important step for the successful approval of a new product and can significantly impact the approval timeline and time to market. The FDA PAI will determine whether an applicant’s manufacturer can adequately produce, and supply commercially, the product it is applying for. Mock-PAIs should be conducted by an independent, non-biased external resource to ensure it is treated like an actual Pre-Approval Inspection.
Our Approach
RegDev consultants take on an immediate interactive role with our clients, functioning as a Mock-PAI Project Manager. We partner with our clients to identify the cross-functional team members who will actively participate in and support the Mock-PAI. The consultants define the scope of assessment, develop an audit plan and timeline, confirm the identified resources, and execute the Mock-PAI project.
CGMP COMPLIANCE
TECHNICAL READINESS
MANUFACTURING RELIABILITY
DATA INTEGRITY
COMMITMENT TO QUALITY
TEST METHOD ADEQUACY
ENSURE MANUFACTURE READINESS
The RegDev Mock PAI process helps ensure and confirm that a manufacturing establishment is acceptable and capable of manufacturing a drug at commercial scale by focusing on the methods, processes, facilities, and controls used to develop and manufacture a product. Our clients benefit because we work to confirm the manufacturing establishment’s Readiness for Commercial Manufacturing, verifying its Conformance to Application, and verifying its data integrity in accordance with the FDA’s Compliance Program 7346.832 Pre-Approval Inspections.
PROACTIVE PROBLEM IDENTIFICATION
It is beneficial to conduct Mock-PAIs approximately one year before the FDA is expected to conduct a formal PAI and before the FDA grants formal approval for a drug application. This allows our clients sufficient time to correct and/or improve any identified issues and prepare for the formal inspection. Timing for conducting a Mock-PAI is especially important for applicants that are less familiar with the overall FDA drug application process (e.g. first-time drug applicants).
ESTABLISHED APPROACHES AND PRACTICES
By demonstrating a commitment to compliance and quality, inspection readiness programs can help improve an organization’s reputation within the industry and with patients.
Testimonial
“The outcome and benefits to our company resulted in a clean FDA PLI Inspection with no 483's. RegDev's expertise and level of
professionalism has been an invaluable endeavor.”
