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Operational Ready vs Inspection Ready: How to Tell the Difference and How to Respond

Operational Ready vs Inspection Ready: How to Tell the Difference and How to Respond

A facility can be ready to manufacture and still not be ready for an FDA inspection.

The equipment may be qualified, operators trained, and production scheduled. But can your team quickly retrieve the right records, explain how decisions were made, and show that procedures match what is actually happening on the floor?

That is the difference between being operationally ready and inspection ready.
Our latest article breaks down how to spot the gaps, test your systems from an inspector’s perspective, and build inspection readiness into everyday operations.

Read the full article here to learn more about CenPharma’s GMP Ready program.

CenPharma

CenPharma News & Announcements

CenPharma is a pharmaceutical consulting firm specializing in compliance, engineering and technical services. We specialize in designing and implementing systems in diverse areas such as method design, method transfer, quality compliance, quality assurance, inspection readiness, process validation, analytical method validation, equipment qualification, facility design, supplier qualification, environmental monitoring, quality management systems, learning management systems, materials management, auditing (hosting and conducting), compliance remediation, quality systems, investigation, root cause analysis, technical writing, change management, data integrity and quality control. Our team consists of experience pharmaceutical industry professionals with expertise in microbiology, engineering, compliance, system design and regulatory affairs.

RXinsider Staff

Posted by: RXinsider Staff

RXinsider is a multimedia publishing and technology company offering print publications, digital platforms, events, and content creation services to the B2B pharmacy market.

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