This episode outlines official FDA guidance regarding the specific behaviors that constitute the obstruction of drug or device inspections. Under federal law, if a facility delays, denies, limits, or refuses an inspection, the products manufactured there are legally considered adulterated. Prohibited actions include failing to schedule pre-announced visits, withholding records, and restricting access to operational areas or photography. While the agency considers legitimate justifications for certain disruptions, such as safety protocols or language barriers, it maintains broad authority to ensure regulatory compliance.

#FDA #RegulatoryCompliance #FDAInspection #Pharma #MedicalDevices #FDALaw #QualityAssurance #AuditReady #LifeSciences #Compliance

This podcast outlines the essential standards for process validation within the pharmaceutical and biologics industries. It establishes a three-stage lifecycle approach that includes process design, process qualification, and continued process verification to ensure drug quality and consistency. The discussion emphasizes using scientific evidence and risk-based analysis to maintain manufacturing control from initial development through commercial production. This podcast provide a framework for meeting Current Good Manufacturing Practice (CGMP) requirements to guarantee product safety and efficacy.

#processvalidation #FDA

This episode talks about the FDA-mandated guidance document for managing out-of-specification (OOS) results within the pharmaceutical industry. The guidance emphasizes a rigorous two-phase investigation to determine if a failure stems from a laboratory error or a deeper manufacturing flaw. Phase I focuses on the analyst’s immediate assessment of technical accuracy, while Phase II involves a full-scale review of production processes by the quality unit. Crucially, the sources warn against "testing into compliance," noting that companies cannot simply retest a sample until it passes without a scientific root cause for the initial failure. Ultimately, the documentation underscores that maintaining scientific integrity and protecting patient safety must take precedence over the desire to release a product batch.