Data Integrity Problems as key Issue for Ranbaxy's Consent Decree

On behalf of the US FDA the Department of Justice has filed a Consent Decree of permanent injunction against the generic drug manufacturer Ranbaxy. The manufacturer agreed to remedy GMP deviations and to correct data integrity issues at several plants. According to the information on FDA's website this Consent Decree

  • addresses outstanding current good manufacturing practice (CGMP) and data integrity issues at Ranbaxy's India facilities as well as CGMP issues at Ranbaxy Inc.'s wholly owned subsidiary Ohm Laboratories facility located in Gloversville, N.Y., USA
  • requires Ranbaxy to comply with detailed data integrity provisions before FDA will resume reviewing drug applications containing data or other information from Ranbaxy's India facilities
  • asks Ranbaxy to hire a third party expert to conduct a thorough internal review at the facilities and audit applications containing data from the affected facilities
  • requests the firm to implement procedures and controls sufficient to ensure data integrity in the company's drug applications (establish an Office of Data Reliability to conduct pre-submission audits of all applications submitted from any facility)
  • further requests Ranbaxy to withdraw any applications found to contain untrue statements of material fact and/or a pattern or practice of data irregularities that could affect approval of the application

This "consent decree of permanent injunction" was signed by Ranbaxy and FDA in late December, when the generic drug manufacturer announced that it had put aside 500 Million US Dollars to cover potential costs.

For further information please see FDA's news release "Department of Justice files consent decree of permanent injunction against Ranbaxy".

The integrity of analytical laboratory data will be addressed in ECA's Education Course "Raw Data, Results and Reportable Values - A GMP-compliant Approach to QC Laboratory Data Management and Integrity" in Copenhagen, Denmark, from 21-22 May 2012.  

Author:
Dr. Günter Brendelberger
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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