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.
Gap Analysis
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.
Post-Inspection Evaluation
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!
Resources
FDA Inspections and Form 483 Responses: What Companies Need to Know
ArticleAn FDA Form 483 response can influence how inspection findings are classified and what happens next. Drawing on NSF webinar insights from former FDA experts Tamika Cathey and Dr. Julia Marre, this article explains what companies should do within the critical 15-business-day response window and where responses often fall short.
How the QA and QP Talent Market Is Changing in Pharma: Insights from Compliance Unlocked Podcast
PodcastRecruiting and retaining experienced quality and regulatory professionals has become significantly more complex for pharmaceutical and biotech companies.
The Foundations of Pharmaceutical Compliance for Beginners
ArticleWhether you’re stepping into the pharmaceutical industry for the first time or pivoting into a compliance or quality assurance role after years of experience, mastering the fundamentals of quality and regulatory compliance is vital to your success—and to the success of your organization.
How NSF Can Help You
