GOOD CLINICAL PRACTICES: INSPECTIONS

 

The GCP inspectorate inspects the clinical trials for the conformity of GCP standards.GCP conducts three types of inspections:

 

Routine inspections : Inspections of procedures used to conduct clinical trials to assure the compliance with the concerned legislation. These inspections are pre-informed.

 

Triggered inspections: These are triggered in response to MHRA licensing requests or in case of reports received by MHRA regarding the violations of legislation for clinical trial conduct. These may be surprise inspections or may be notified earlier.

 

CHMP requested inspections resulting from MA submissions: These inspections are conducted by EMEA EU inspectors in response to the CHMP and in relation to marketing applications made using EU standard procedure.

 

GCP inspectors can enter any premises where the clinical trials are being conducted and can carry out inspections .All these activities are included in the rights of GCP inspections. To obstruct any inspector during the conduct of an inspection is a criminal offence under the section 114 (2&3) of the medicines act 1968.

 

The inspectorate reports to the Director of the Inspection and Standards (I&S) division who in turn reports to the Health ministry via the MHRE Agency board.

 

For a drug to be approved, it is necessary to perform the clinical trials in accordance with the GCP or in case of violation of GCP guidelines, clinical trials are liable to be withdrawn.