GxP Audits Guide For Successful Clinical Trials

By Lella Baker, Senior GxP Consultant

A well-designed GxP audit program not only meets the regulatory requirement of sponsor oversight but also enables the early detection of potential issues, the development of key performance indicators (KPIs), and the establishment of best practices within an organization. GxP audits are essential for ensuring compliance and maintaining quality in clinical trials.

This step-by-step guide helps sponsors and sites prepare for and navigate the various types of audits required at each stage of the clinical trial process. An effective clinical quality assurance (CQA) audit program should include three main components: investigator site audits, vendor (supplier) audits, and internal audits (covering processes, systems, or individual departments).

Unlike current good manufacturing practices (cGMP), which are detailed in the U.S. Code of Federal Regulations (CFR) under 21 CFR parts 210 and 211, clinical trials must adhere to multiple areas of GxP as specified in the CFR. These include good laboratory practices (GLP) under 21 CFR part 58, good pharmacovigilance practices (GVP) under 21 CFR parts 314 and 600, and good clinical practice (GCP) under CFR parts 50, 54, and 56. Each of these areas must be thoroughly reviewed during the clinical trial process to ensure full compliance with regulatory standards.