FDA officials: Firms with strong quality cultures more resilient to data integrity problems

US Food and Drug Administration (FDA) officials asserted at a 26 April Generic Drug Forum (GDF) that firms with weak quality cultures are more susceptible to submit abbreviated new drug applications (ANDA) with data integrity problems than companies with stronger culture. Yet officials continue to see data integrity problems across the board, affecting all elements of ANDA submissions.

At the forum, which was sponsored by FDA’s Small Business and Industry Assistance (SBIA) program, officials discussed some of the data integrity problems in ANDAs, ways to address the problem and some common misperceptions of data integrity.

Nilufer Tampal, associate director for scientific quality for the agency’s Office of Bioequivalence in the Office of Generic Drugs (OGD), said that data integrity problems continue to bedevil the industry. She added that data integrity was also a theme at last year’s OGD forum, which “underscores the agency’s concerns and seriousness of the issue before us. Specifically in recent years, we are seeing new lows in data integrity involving data falsification.”

She said reviewers are seeing data integrity violations across the board in ANDA submissions, including bioequivalence studies; non-clinical studies; and in the chemistry, manufacturing and controls (CMC) area.

For example, data integrity problems found in BE clinical studies include “unethical conduct” for enrolling subjects in clinical studies and failing to report adverse events and serious adverse events, including deaths.

For non-clinical studies, these lapses include using animal data from a different species, repeating data, and reporting “implausible” biological results.

In the CMC area, these lapses include fabricating data and failing to justify out of specification results. For BE bioanalysis studies, these problems include manipulating values in statistical analyses, not investigating frequent run failures, and not investigating consecutive quality control failures.

Strong quality culture can counteract problems

Tampal said that firms with a strong quality culture are in a better position to prevent data integrity problems from occurring. A strong corporate quality culture is where “leadership is committed to promoting a work environment that supports integrity and quality of the product and has developed detailed policies regarding standards for ethical conduct,” she said.

Companies also need to continually reinforce a strong quality culture through “continual education and training.” She said that “it is important for leadership to underscore the quality of data is everyone’s responsibility within the organization.”

A strong quality culture “encourages open and transparent communications between all levels,” Tampal said, especially for reporting errors and deviations.

Misperceptions about data integrity

Shujen Chen, a senior pharmaceutical quality assessor with the Office of Pharmaceutical Quality, sought to dispel some common myths about data integrity breaches. One is that data integrity problems are only found in the quality controls laboratory, which she said is false, because these problems can occur anywhere in the company.

Another myth is that senior management “is not responsible and could not have known” about the problem while another is that terminating an employee that was responsible for a data integrity breach would take care of the problem.

Chen also reiterated Tampal’s point that firms with “deficient” quality cultures are more susceptible to data integrity problems. A weak quality unit may be “aware of the lack of controls in the computer systms but failed to correct problems. Or a weak quality culture is one where site senior management failed to take sufficient action to prevent recurrence of data integrity problems.”

FDA

FDA officials: Firms with strong quality cultures more resilient to data integrity problems

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