Pre-Approval Inspection (PAI) Readiness

Remediation and Optimization

As an outcome of the Inspection Readiness Evaluation or other gap assessments, remediation or optimizations efforts with respect to policies, procedures, practices, documentation, facilities, etc. will likely be required. These activities can vary in size, criticality, or effort. Teaming with ProPharma for your firm’s remediation and optimization needs puts your firm closer to the finish line on your road to filing and Inspection Readiness. We have the experience and expertise to help guide you through the activities and ensure compliance and quality are maintained throughout.

Develop an Inspection Program or Optimize Existing Program

ProPharma can create Standard Operating Procedures (SOPs) on how inspections are handled at your organization and/or vendor organization. We can implement request and response processes (paper-based or electronic). We can develop all of the tools necessary for a successful PAI. Alternatively, we can review your existing Inspection processes and optimize them as necessary.

Training

ProPharma can provide and execute various trainings to ensure Inspection Readiness. The entire organization will be trained on why PAIs occur and what to expect. Additionally, SMEs require and benefit from training on proper interviewing skills and responses to Inspectors’ questions. And finally, the Inspection Management Team’s training on roles, responsibilities, and their deliverables to ensure a smooth inspection experience for all.

Mock Inspections

ProPharma has helped many organizations plan and execute Mock Inspections with utilization of our former FDA investigators as well as our industry experts. Mock Inspections help ensure that the implementation, remediation, or optimization of processes has been a worthwhile effort as well as ensuring training on Inspection behavior has been successful.

Post-Readiness Activities

• Inspection Support: Take a role in your inspection, as a part of your Inspection Management Team
• Response Support: ProPharma is adept with Agency responses to observations, utilizing a holistic and S.M.A.R.T. approach (Specific, Measurable, Attainable, Relevant, and Timebound)
• Additional remediation activities support