Guideline for good clinical practice inspection, version 002

Abstract

Good Clinical Practice (GCP) Inspection refers to a systematic and independent examination of clinical trial process and documentation to ensure compliance with GCP guidelines and regulatory requirements. Its purpose is twofold; Quality Assurance (to uphold the highest standards of GCP, ensuring that trials are conducted ethically, transparently, and in accordance with regulatory requirements) and Continuous Improvement (to foster a culture of learning, where insights from inspections lead to corrective actions, preventive measures, and overall enhancement of clinical trial practices).