Can your data integrity practices withstand growing scrutiny?
In light of the FDA's recent warnings we consider areas where the pharmaceutical industry needs to improve
Last month, FDA inspectors continued to find failings across Aurobindo Pharma’s sterile drug plant in Telangana.
One of the key issues observed by inspectors was the lack of adequate data integrity programs in place to ensure the completeness, consistency and accuracy of all raw date.
There was also a notable gap in the plant’s ability to review and investigate electronic raw data. The plant often failed to implement relevant CAPAs when issues were discovered and failed to comprehensively address all potential root causes.
The plant was also lacking appropriate controls over their computers and related systems, meaning that unathourized personnel were able to institute changes in master production and control records.
FiercePharma noted that as Aurobindo Pharma has grown in prominence, currently claiming to be the second-largest generics producer for the U.S., the regulatory scrutiny for their actions has increased. In the past three years alone, they have already received 10 Form 483s.
This is a trend being seen across the industry, with the regualtory focus on data integrity principles and practices increasing.
The FDA’s growing focus on quality control
In a recent webinar with Pharma IQ, Steven Brown, Data Integrity Lead at Novartis, shared how in their efforts to continuously improve data integrity practices, the company conducted a review of all FDA warning letters since 2015.
In many of these letters, audit trails, eSecurity and GDP were highlighted, but the standout issue across 70% of letters was clearly quality control.
The issues raised under the term quality control were wide ranging. They covered testing into compliance, disregarding or retesting results, failing to put in adequate access controls and not taking a risk based approach to data review. Two additional prominent issues in QC were poor document or sample management and human factors, including poor data recording and falsification.
Considering this focus, we are likely to see scrutiny on these areas increasing from all regulatory bodies. In advance of this, Novartis have already begun to ensure increased levels of data integrity, implementing comprehensive systems and processes.
It is highly recommended that companies begin to take a strong look at their data integrity processes and how diligently their staff are following such processes. A single warning letter can have a significant impact on production and can open up a growing number of issues.
With the FDA taking a closer look at all data practices, the pharmaceutical industry must prepare.