Bioequivalence and Bioavailability Forum

Hi Jasim,

You may ask the CRO to provide any certification (if they have any) stating the GCP compliance from any of the regulatory agency (may not be same agency to which you have submitted the study) and if no formal certification is available, you may ask for the list of audit reports and compliance reports for regulatory audits different regulatory audits conducted at that CRO indicating that procedures are established for regulatory compliance.

In addition, ask the principal investigator to give a declaration stating that GCP was followed during the study conduct and you may keep the GCP training evidence received by the key study personnel.

Other comments are appreciated.

Regards,

Debbie.

Dear Jasim!

❝ We have conducted BE Study in India through a CRO and submitted the report to one regulatory authority.

GCP is mandatory in India (see here). The principal investigator should state in the final report that the study was performed according to the principles of GCP.

❝ But regulatory authority has asked to provide evidences that the study has been conducted following Good Clinical Practices.

May I ask which agency you are dealing with? In my experience the ones from Turkey and Jordan routinely ask for a “GCP Certificate”* – which does not exist in most countries. GCP generally is part of the national medicines laws and not complying with its principles simply is a crime.

❝ Could you please tell us what evidences we can ask from our CRO regarding GCP?

I would follow Debbie’s suggestions above. But: It is your responsibility to check beforehand (!) that the CRO will be able to perform the study as planned. See the Indian GCP:

3.1.1. Investigator and Institution Selection:
The Sponsor is responsible for selecting the Investigator(s) / Institutions taking into account the appropriateness and availability of the study site and facilities. The Sponsor must assure itself of the Investigator’s qualifications and availability for the entire duration of the Study.

If you haven’t done so, go there and perform an audit now (not only the actual study, but the entire system). It would also help if you monitored the study.

BTW, “evidence” is such a big word. One of the common phrases of GxP is “If you haven’t written it down, you didn’t do it.” What if the paperwork is falsified? IMHO it works only the other way ’round: If something was done violating GxP and documented as such (or, like in most cases the study personnel was too stupid to fake something in a clever way) an inspector would have “evidence of noncompliance”.
I think that “evidence of compliance” is impossible.

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• I know one Indian CRO proudly presenting a GCP-certificate issued by the Turkish Ministry of Health on their website. I’ve heard that their study conduct is sloppy at least or even close to fraud.