Vendor Qualification Audit
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During Vendor Qualification Audit, Auditors generally reviews Quality Management Systems and Training Records and other documents (generally which are not project specific) and interviews the staff in limited time. My concern is, when Auditor wants to qualify a vendor, he would be qualifying based on procedures mentioned in the SOPs and other documents and assuming that it would be done correctly as mentioned in SOPs. In case, during the study conduct or while availing the services if Sponsor representative/Auditor finds issues in the Quality, reliability and credibility of the data and procedure then in such case whether Auditor is responsible for qualifying such non-compliant vendor. It would be great if anyone has experienced this scenario and handled such situations. Thanks in advance.
It is almost imposable to understand what you are asking.
"Vendor Qualification Audits" are by their nature a prospective assessment of whether the systems (& resources) of a vendor look as if they might be compliant. In GCP there is not absolute requirement to perform a qualification audit, in fact audits of vendors will be risk based and may not happen at all, or may be part of a cycle. Audits of a trial involving a vendor, will obviously involve audits of the data and the systems used at the time of the trial. These may well reveal non-compliances.
RQA GLP Committee
This is a similar situation to regulatory inspections. The first inspection looks at the systems etc, and the second inspection looks at how the work has been conducted in reality. The RQA booklet on hosting a GLP inspection draws this comparison as it does include sponsor audits in its scope. It should be remembered that a facility is only as good (or bad) as its last inspection, and you should be prepared to adjust your requirements accordingly depending on the outcome of each audit.