Good Clinical Practice (GCP) Auditing Services

Current Inspection Trends Tailored to Your Unique GCP Audit Request

Organizations seeking assistance with Good Clinical Practice (GCP) audits for their clinical programs have varying needs, one size does not fit all. ProPharma Group’s compliance colleagues collaborate with your organization to establish a comprehensive partnership customized to your clinical program needs.

This tailored approach reflects current FDA, EMA, and other local regulatory authority governing legislation guidelines, inspection trends, and compliance practices. Aligned with our compliance portfolio, ProPharma Group is positioned as an ideal partner for complete clinical audit program support.

Our consultants have extensive audit and operational experience in at least one GxP area of expertise (GMP, GDP, GVP, GCP, GLP and/or IT/CSV) and support qualification audits, mock regulatory inspections, gap analyses, quality management system development and optimization, and quality system management.

Audit Methodology

ProPharma Group will work with your team to:
  • Establish type and goal of each audit
  • Design and update audit plan in conformance with your audit SOPs
  • Coordinate timing of audit
  • Develop audit plan
  • Conduct the audit
  • Prepare audit report
  • Provide CAPA recommendations and triage
In case of a series of audits, ProPharma Group may assign a Project Manager, who will act as the primary point of contact to discuss any audit needs and preferences, while the assigned auditor will facilitate the execution of the audit activities and ensure consistency with your clinical audit program.