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.