“Data integrity is nothing new,” Octavi Colomina, President of the Asociación Fórum Auditorias, told delegates of the CPhI Worldwide Pre-Connect Congress in Madrid this week. “It is a requirement as old as GMP itself.”
But the issue has become “the hot topic” for industry over the past few years, being brought to the forefront through a rise in US Food and Drug Administration (FDA) warning letters containing serious GMP violations referring to deficiencies in data integrity.
Colomina attributed this statistic to stronger regulatory focus on data integrity. “Now the FDA is training people and employing experts in data integrity,” he said, adding when this was extended to facility audits such issues came to light.
Definition and Causes
Data integrity refers to the accuracy and consistency of data generated during GxP, and Colomina said inspectors require such data to be attributable to the person who generates it, legible and permanent, contemporary, original and accurate.
The FDA itself, he said, cites “invalid or not reliable data is a sign of poor control on the operations and equipment and therefore the company is unable to ensure the expected quality of process.”
While sources of data integrity violations include batch records, equipment cleaning records and training records, Colomina said 80% of issues are quality control (QC) related, with HPLC the number one cause.
Within chromatography, many companies have been pulled up on the deletion and overwriting of data, the altering of integration parameters, and continually testing until they arrive at the results they want.