Data Integrity Questions Continue


In a recently posted USFDA warning letter, dated October 14, 2014, for a March 2014 inspection identified the following issues.

The firm failed to:

  1. Prevent unauthorized access or changes to data and to provide adequate controls to prevent omission of data.  For example, lack of access controls to prevent the deletion of or alteration of raw data, GC software that lacked audit trail functions.  Additionally, management explained that it was the firm’s practice to delete raw data files once the chromatograms were printed.
  2. Establish adequate controls for issue of batch records.  For example, operators had the ability to print batch records from their personal computers, and uncontrolled batch records were found in the production office.
  3. Poor documentation practices.  For example, the firm used correction tape over multiple raw material batch numbers, and the recurring use of correction fluid to make corrections.  Although the firm has an SOP, which precludes these actions, there was no documented operator training on the SOP.
  4. Validate non-compendial analytical test methods.  For example, the chromatograph analysis could not be demonstrated to be suitable for its intended purpose and did not comply with the official USP monograph for the associated product.
  5. Batch records for non-US products were not signed when completed; these sections were dated but not signed.  Additionally, several pages within the manufacturing section of the batch record were completely blank.

These findings are similar to other data integrity and manipulation issues identified by USFDA throughout 2014 and earlier.  Inadequate security to allow laboratory operator’s access to raw data, software that is either inadequate or incorrectly configured to prevent data deletion or manipulation.  Poor work practices with respect to (Good Documentation Practices) how to properly document and if necessary correct the documentation of Good Manufacturing Practices (GMP) activities, and a lack of training on the governing procedure by the firm’s operators.

Based on the number and type of findings, one can assume that these practices are commonplace within the firm.  Where is the firm’s internal audit team in identifying and correcting these issues, and where is the firm’s management in implementing and maintaining an appropriate GMP compliant culture?