Preparing for GxP Inspections

Identify key risks and follow expert mitigation strategies prior to your GMP inspection. We'll help you prioritize and address concerns, creating perpetual inspection readiness.
The business team is meeting in the conference room - Preparing for GxP Inspections | NSF

When your company embeds quality and GMP compliance into every process, you prepare your team to respond to auditor questions and lay the groundwork for better inspection results.

Designate subject matter experts to own each process, coach them on the inspection process and develop your inspectional readiness program.

Our independent, proportionate and objective review of your entire quality system ensures that you'll be perpetually ready for GMP inspection, giving you peace of mind.

Gap Analysis

A measured, comprehensive and collaborative gap analysis reveals the effectiveness of your quality system and its compliance with cGMP requirements. Review and analyze your policies and procedures, facilities and utilities, equipment, materials control, production and laboratories. Evaluate your company's staff behavior, quality culture and subject matter expertise.

Corrective and Preventive Action

NSF ensures your remediation activities are pragmatic, solution focused, well designed and effective. With controls and monitoring in place, you'll make key investments to achieve the best results.

Investment in Subject Matter Experts

Professional development for your staff is a key part of any improvement project. Our coaching and mentoring methods enhance the expertise and insights of your team and deliver measurable results. We provide science, compliance and leadership-based coaching and mentoring to help your staff prepare, execute and respond to GMP inspections.

Mock GMP Inspections

Our industry experts and former regulatory inspectors provide an unrivaled “dress rehearsal” for your GMP inspection. Receive a pinpoint assessment of your inspection readiness, as well as expert guidance for managing the inspection itself. We can also support you before, during and after the inspection.

Real-Time Inspection Support

We provide strategic interpretation of the inspector’s needs in real time, guide your team to the best outcomes and support immediate corrections, corrective actions and preventive actions.

Post-Inspection Evaluation

Evaluate each concern identified by your regulatory inspector. We'll help you establish a product quality impact assessment, analyze root causes and develop proportionate and sustainable corrective actions or preventive actions. Develop your team, facilitate ownership and always be inspection ready!

Ready to Begin the Process?

Contact us with questions or to receive a quote.

News and Events

NSF Now Offering Live Instructor-Led Virtual Pharmaceutical and Medical Devices Training

May 19, 2020

To complement its face-to-face offering, NSF now offers traditional classroom courses as virtual instructor-led training to support your professional development. Courses are delivered via a combination of live instructor-led virtual classrooms and self-paced online learning. NSF’s coaches are on hand to guide participants through the interactive sessions which also include pre- and post-course activities.

NSF’s Health Sciences Team Joins Fight to Save Lives With More Ventilators

April 23, 2020

NSF’s health sciences team is hands-on in the rapid ventilator manufacturing specification issued by the United Kingdom (UK) government. The UK National Health Service needs thousands more ventilators to help save lives as the country’s COVID-19 pandemic approaches its expected peak and ventilator capacity becomes a challenge.

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The U.S. NIST has developed a framework to better manage risks to individuals, organizations and society associated with artificial intelligence (AI).

March 2023 Medical Device and IVD News Update

March 1, 2023

Welcome to our March Medical Device and IVD news update. Every month we'll bring you the latest medical device and IVD industry news, useful articles and resources, expert advice, training, and events for your calendar.