The FDA investigators have detected several deviations which result in  serious lack of data integrity. These deviations were detailed in recent warning letters.

Apart from the list of fundamental GMP compliance failures (not respecting ALCOA principles), the FDA also includes the advice to firms that failed to meet the Data Integrity principles that they should seek assistance from ‘Data Integrity Consultants’. Note that the consultants chosen should be ‘experienced in detecting data integrity problems’.

As per the FDA Warning Letters text:

“Your data integrity consultant should:


1. Identify any historical period(s) during which inaccurate data reporting occurred at your facilities.


2. Identify and interview your current employees who were employed prior to, during, or immediately after the relevant period(s) to identify activities, systems, procedures, and management behaviors that may have resulted in or contributed to inaccurate data reporting.

3. Identify former employees who departed prior to, during, or after the relevant periods and make diligent efforts to interview them to determine whether they possess any relevant information regarding any inaccurate data reporting.

4. Determine whether other evidence supports the information gathered during the interviews, and determine whether additional facilities were involved in or affected by inaccurate data reporting.

5. Use organizational charts and SOPs to identify the specific managers in place when the inaccurate data reporting was occurring and determine the extent of top and middle management involvement in, or awareness of, data manipulation.

6. Determine whether any individual managers identified in item (5) above are still in a position to influence data integrity with respect to CGMP requirements or the submission of applications; and establish procedures to expand your internal review to any other facilities determined to be involved in, or affected by, the inaccurate data reporting.

7. As part of this comprehensive data integrity audit of your laboratory, your audit report also should include any discrepancies between data or information identified in approved applications, and the actual results, methods, or testing conditions submitted to the Agency. Include an explanation of the impact of all discrepancies. Provide a corrective action operating plan describing the specific procedures, actions and controls that your firm will implement to ensure integrity of the data in each application currently submitted to the Agency and all future applications. This should not only cover methods validation, but any other testing (e.g., stability tests, release tests) you have performed for customers that may have been used to support a drug application-related submission to the agency.”

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