Many have heard the idiom “an ounce of prevention is worth a pound of cure.” More simply stated, the Oxford Languages Dictionary states that “it is easier to stop something from happening in the first place than to repair the damage after it has happened.”
This adage can be applied to the regulated industry in that future compliance issues can be prevented through proactive measures.
An ideal approach to prevention is adopting a continuous state of inspection readiness throughout drug, biologic, and device development lifecycles. Continuous Inspection Readiness is a cyclical exercise. Through this approach, one can minimize the last minute preparation that goes into preparing for an FDA inspection. This approach might include gap analyses, training of SMEs and executive team members, Trial Master File (TMF) audits, MOCK Inspections that simulate Health Authority Regulatory Inspections and pressure test team members, development of seamless story boards to address gaps and MOCK Inspection Observations.
I have personally conducted each of these inspection readiness activities for FDAQRC clients over the past 6 years and personally believe that clients that engage in inspection readiness activities early and often in their regulated product life cycle fair the best with subsequent FDA approvals.
When the actual Health Authority Inspection occurs, enter Health Authority Observations, root cause investigations, and Corrective and Preventive Action (CAPA) followed by a written response to the Health Authorities. There will be significant effort in ensuring that responses to Health Authorities are understandable and obvious to the reviewing official; brief and to the point; convincing and engaging; thorough; and conforming to applicable regulations.
Once the inspection and regulatory response process has occurred, it is time for renewed dedication and continuous inspectional readiness investment to occur for the remainder of the regulated product lifecycle.
Need help implementing these proactive measures before your next audit? FDAQRC is a global leader in comprehensive GxP solutions.
Learn more about our Inspection Readiness Services, Quality Audits, and Remediation Services, by contacting us today to speak with a compliance expert.
