Preparing for GxP Inspections
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 programme.
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.
A measured, comprehensive and collaborative gap analysis reveals the effectiveness of your quality system and its compliance with cGMP requirements. Review and analyse your policies and procedures, facilities and utilities, equipment, materials control, production and laboratories. Evaluate your company's staff behaviour, 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 unrivalled “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.
Evaluate each concern identified by your regulatory inspector. We'll help you establish a product quality impact assessment, analyse root causes and develop proportionate and sustainable corrective actions or preventive actions. Develop your team, facilitate ownership and always be inspection ready!