Data Integrity

Data integrity
In a recently posted warning letter a number of issues were identified concerning data integrity of laboratory results.  These results included:
Laboratory personnel used a software function “inhibit integration” without scientific justification. As identified in the warning letter:

Inhibiting integration at various points during release testing for commercial batches is not scientifically justified. It can mask identification and quantitation of impurities in your API, which may result in releasing API that do not conform to specifications.

The FDA identified that audit trail functionality had been enabled the day prior to the FDA inspection. Additionally, there were no procedures in place for Quality to review and evaluate the audit trail data.
Records requested by FDA (audit trail data) were provided in the form of excel spreadsheets rather than direct exports from the chromatographic software. As reported in the warning letter:

…were not the original records or true copies, and showed signs of manipulation. The records you did provide contained highlighting, used inconsistent date formats, and lacked timestamp data; these features are inconsistent with original data directly exported from chromatographic testing software.
Our investigators and their supervisor explained at least twice that the data you provided was not representative of actual audit trail data from the chromatographic systems, and requested that you provide the original, unmodified records.

Lastly, the FDA stated, “Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. We acknowledge that you are using a consultant to audit your operation and assist in meeting FDA requirements.” This section concludes with a substantial listing of information the company is to provide to FDA in response to the warning letter.

Have a question on Data Integrity?  The ISPE Great Lakes Chapter will be providing a one day training session on Data Integrity June 15, 2017 in Indianapolis.  Click here for more information and registration.