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WHO: 'Critical' Data Integrity Issues Found at Indian CRO

Posted 07 July 2015 | By Michael Mezher 

WHO: 'Critical' Data Integrity Issues Found at Indian CRO

Quest Life Sciences, an Indian contract research organization is under fire after World Health Organization (WHO) inspectors uncovered 'critical' data integrity issues during an inspection last October.


As part of its Prequalification of Medicines Programme, WHO carries out inspections of companies involved with clinical research and manufacturing to ensure prequalified medicines are of "acceptable quality, safety and efficacy."

The program focuses on products used for HIV/AIDS, malaria, tuberculosis as well as reproductive health and is used to vet drugs procured by aid organizations such as UNICEF, UNAIDS and the Global Fund to Fight AIDS, Tuberculosis and Malaria.

When a company fails to meet standards such as good manufacturing practice (GMP), good clinical practice (GCP) or good laboratory practice (GLP), WHO can issue a Notice of Concern, which remains active until a company can satisfactorily correct any issues identified in the notice.

Data Integrity Issues

In October 2014, WHO inspectors visited Quest Life Sciences' site in Chennai, India to review a study being conducted by Quest on three HIV/AIDS drugs.

The study was commissioned by Micro Labs Ltd., a major generic drug manufacturer recently hit with a Notice of Concern from WHO and a warning from the US Food and Drug Administration for GMP issues at one of its sites in India.

According to WHO, its inspectors uncovered "critical and major deviations from the WHO [GCP] and [GCP] standards," which were outlined in an Inspection Report sent to Quest on 26 March 2015.

In its report, WHO noted two critical issues related to data integrity. First, inspectors discovered that more than two-thirds of the pre-study electrocardiograms (ECGs) used by Quest were duplicates, modified to "appear as if they were from each of the different subjects who participated in the study."

Second, inspectors found "A number of forms relating to the LAZ-032-13 study were in the process of being completed during the inspection as they had not been filled at the time of the activity," in attempt to back-date certain records. Additionally, inspectors discovered original results from a breath analysis test that had been discarded and found Adobe Acrobat Editor installed on computers within Quests quality assurance department, which in light of other data integrity issues, was raised to a critical observation.

WHO says it received Quest's "partial response" on 30 April 2015. However, the agency said Quest's response did not adequately address the serious issues outlined in the inspection report, as "retrospective corrective action was not considered to be possible for the study under review, and corrective actions would be required."

As such, WHO is recommending the Quest study be rejected, and says its Notice of Concern will remain active until a new study is conducted.

Parallels to GVK Biosciences

The issues identified in WHO's inspection of Quest are reminiscent of the recent incident involving data integrity with another Indian CRO, GVK Biosciences.

In May 2014, inspectors from the French National Agency for Medicines and Health Products Safety (ANSM) uncovered evidence that GVK had similarly manipulated the results of ECGs used in studies it conducted.

As a result, the European Medicines Agency (EMA) ultimately recommended suspended the marketing authorizations from more than 700 products that relied on studies conducted by GVK.

Speaking to Reuters, Joseph Kamlesh, head of operations for Quest called the issues identified by WHO "isolated," and said they "could not be compared with the problems at GVK."


WHO Notice of Concern

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