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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:
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Study related activities to determine consistency
with the protocol.
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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.
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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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