GCP Quality Management

Quality is key to how you conduct your GCP research, whether you are a large or small organization.

The addendum to ICH-GCP Guidelines for Good Clinical Practice E6 (R2), effective 14 June 2017, and the ICH Reflection on “GCP Renovation”: Modernization of ICH E8 and Subsequent Renovation of ICH E6 provide clear indication that regulators worldwide agree that a robust Quality Management System is an integral part of  Clinical Research & Development to ensure patient safety and robust scientific methodology.

More Sponsors are finding their existing Quality Management Systems under the spotlight as regulators now include an in-depth assessment of quality practices during their Regulatory Inspections. Proving the suitability of the Quality Management System can be an issue for many organizations of all sizes.

RPR Consulting provides GCP Quality Management consultancy and Regulatory Inspection preparation and support to pharmaceutical and biotechnology organizations of all sizes.

What We Do

RPR Consulting offers two key services to the biopharmaceutical industry:

Quality Management System (QMS) Development

We provide a pragmatic, holistic perspective to improve your existing GCP Quality Management System, or can work with your team to create a tailored, risk-based Quality Management System for your organization from the ground up.

In addition, RPR Consulting provides a thorough review of your procedures to identify opportunities for improvement and deliver “quick wins” for your quality system.

Regulatory Inspection Preparation and Support 

We all recognize that clinical research rarely follows the path that we intend; in the complex world of human clinical trials there are inevitable deviations from plan. Having said that, the time for this to be first discussed is not during a GCP inspection associated with your regulatory submission, and preparedness is key to being able to successfully explain how you correctly dealt with these issues.

RPR Consulting has significant experience in hosting and managing regulatory inspections at both Sponsor sites and Clinical Sites.  We can provide a full GCP regulatory inspection readiness program; from initial gap analysis, development of mitigation and remediation strategies, staff training for interviewees and the ‘back room’ team, mock-inspections, through to on-site management and support during the inspection itself.

Contact

For more information on how RPR Consulting can help you deliver your GCP Quality Management System

Phone: (+1) 484-983-4583

Email: rprconsultinginc@gmail.com

About

Richard Reeve, President of RPR Consulting, has over 25 years experience in Clinical Quality Management and Clinical Operations in Pharma, Biotech and CROs in the EU and US. He has a proven track record of establishing and re-engineering GCP quality systems, and helping Sponsors prepare for and successfully complete regulatory inspections directed by FDA and EMA.

Combining a business-focused approach with practical operational experience he quickly identifies potential compliance issues and areas for optimization in your GCP system.

Blog

Reflections from 25+ years of GCP…