Regulatory & Quality: Pharma & Biologics

1. Our quality system meets current GMP expectations for our stage.

2. Quality has the authority and independence to stop a release.

3. Deviations and CAPAs are closed on time with root causes we trust.

4. Each program has a clear regulatory strategy and a dated submission plan.

5. Our CMC package keeps pace with clinical progress.

6. We track commitments to regulators and meet them on time.

7. Lab data is complete, attributable and protected from change.

8. Methods are validated or qualified for their stage of use.

9. Out-of-specification results are investigated the same way every time.

10. CDMOs and critical suppliers have quality agreements and are audited on a schedule.

11. We have a backup for every single-source material or site.

12. Tech transfer between sites is planned and documented.

13. We could host a pre-approval or routine inspection next month.

14. Pharmacovigilance and safety reporting are staffed and on time.

15. Findings from past audits are closed and stay closed.