What Every Pharma Executive Should Know
At the 2025 FDA Generic Drugs Forum, OGD’s Darby Kozak revealed a striking statistic: 75% of delayed ANDA approvals stemmed from data integrity issues. For executives, this is a clear signal inspection readiness must start at the top.
Here’s a distilled roadmap to prepare for an FDA Pre-Approval Inspection (PAI) and build lasting data integrity compliance:
Top 5 PAI Readiness Actions
- Audit Data Integrity: Evaluate ALCOA+ compliance across systems and records.
- Mock FDA Inspection: Test cross-functional response through realistic simulation.
- Reconcile ANDA vs. Practice: Ensure site operations reflect what’s in your submissions.
- Third-Party Oversight: Review CDMO/CRO agreements, systems, and data reliability.
- Align for Launch: Integrate regulatory, supply chain, and QA for market readiness.
Leadership-Driven Data Integrity
Data integrity isn’t just an IT or QA issue it’s a business risk and leadership responsibility. Here’s how to embed integrity across your operations:
- Create Awareness: Train all staff on ALCOA+ and embed compliance into culture.
- Classify & Secure Data: Use risk-based classification and secure access controls.
- Map Data Flows: Ensure full traceability from creation to archival.
- Enable Audit Trails: Role-based permissions with validated audit capabilities.
- Prepare for the Real World: Controls should be visible in your QMS, not patched in last-minute.
A Sustainable Plan for Ongoing Compliance
Even after inspection, your systems must support continuous improvement. Regular gap assessments and CAPA execution can uncover weak spots before regulators do.
Pro tip: Document everything, trace every change, and ensure all data digital or paper is legible, reliable, and attributable.
If you’re navigating inspection challenges, data concerns, or want a second set of eyes on your readiness plan Let’s talk.
