Good Clinical Practice Inspections

R.K. Rishi

Introduction: Regulation of on clinical trials with medicinal products also includes Good Clinical Practice (GCP) inspections. GCP inspection is part of the surveillance program of the drug regulatory agency in order to verify compliance with the provisions of GCP and thus, to ensure the protection of trial subjects, the credibility and reliability of clinical trial results, and pro-active protection of patients. They are carried out in order to verify patient safety and integrity, protection of patient who will or are participating in clinical trials. It aims to provide public assurance that the rights, safety and well being of trial subjects are protected and the clinical trial data generated is credible.

GCP inspection covers various organizations involved in the clinical trial process including clinical investigators, sponsors and monitors, contract research organizations (CROs), laboratories, and institutional review boards. Since GCP inspections are carried out all over the world, reports of inspection should be acknowledged by other countries. Therefore, there is a need for quality assurance and harmonization of inspection procedures. In case of global clinical trials, considerable number of sites is involved in different countries. Due to this, there is also a need for coordination of GCP inspections between drug regulatory agencies of different countries.

Difference Between Audit and Inspection
Indian GCP guidelines define both audit and inspection. An audit of a trial is a systematic study, carried out by persons not directly involved, such as:

  • Study related activities to determine consistency with the protocol.

  • Study data to ensure that there are no contradictions on Source Documents. The audit should also compare data on the Source Documents with the interim or final report. I should also aim to find out if practices were employed in the development of data that would impair their validity.

  • Compliance with the adopted Standard Operating Procedures (SOPs).

An inspection is defined as an official review/ examination conducted by regulatory authority(ies) of the documents, facilities, records and any other resources that are deemed by the authority(ies) to be related to the study. The inspection may be carried out at the site of the trial, at the sponsor’s / or CRO’s facilities in order to verify adherence to GCP as set out in these documents. 


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