ABSTRACT

Good Clinical Practice (GCP) inspection is required to assure the integrity of scientific testing and research conduct as well as the protection of study subjects' rights, safety, and well-being. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has requested GCP inspection. To investigate a complaint about the way the study was carried out at a particular site and to verify the accuracy and validity of the data that has been provided. This inspection will be carried out by GCP inspectors employed by the Clinical Trials Regulatory Division. In order to make sure they are available, clinical trial inspectors are usually notified four to five weeks prior to the planned inspection date. The CAPA (Corrective and Preventive Action) Plan inspectee is obliged to address the list of deficiencies within 20 working days of obtaining the inspection report. This response needs to include a plan for preventive and corrective measures along with a deadline for their completion. To ensure adherence to GCP standards, inspectors can receive instructions on how to initiate and conduct remote inspections. The study cover every stage of remote GCP inspections, but they concentrate especially on the more difficult ones, like planning, feasibility analysis, and inspection initiation. Keywords: EMA, Clinical Trials Regulation, GCP, CAPA, CHMP
Publication date: 01/12/2025

https://ijbpas.com/pdf/2025/December/MS_IJBPAS_2025_9686.pdf

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https://doi.org/10.31032/IJBPAS/2025/14.12.9686