F2I Partners LLC

Some teams sprint into manufacturing thinking: “We’ll clean up the tracking later.” But regulators don’t issue credit for future intentions. 🛑 If you don’t have traceability on Day 1, you don’t have traceability. Inspection readiness isn’t: ❌ Binder checks one month before PAI ❌ A heroic CAPA cleanup at the finish line Inspection readiness is: ✅ Every batch reviewed with rigor ✅ Training demonstrably linked to current instructions ✅ Deviations resolved based on science and r

GMP. Good Manufacturing Practice. It was designed to protect patients. It ensures consistency, safety, and control. But somewhere along the way, we started treating GMP as a ceiling, not a floor. We stopped asking, “How can we do better?” and started saying, “At least it’s compliant.” --- When Compliance Becomes Complacency In too many facilities, “GMP-compliant” has become synonymous with “ mission accomplished .” Documentation gets prioritized over design, approvals over i