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Pharma has huge responsibilities resting on its shoulders to deliver safe and effective medicine.
Pharma has huge responsibilities resting on its shoulders to deliver safe and effective medicine. As the push for transparency heightens, the industry finds itself increasingly being scrutinized in many areas, from drug pricing and the reporting of all clinical trial results to business ethics, sales and marketing activities, and quality control of manufacturing operations. But how well is Pharma managing regulatory compliance? A PwC report (1) in March 2016 noted a rise in the number of pharmaceutical companies being issued warning letters by the United States Food and Drug Administration for GMP violations related to data integrity deficiencies. The three most common data integrity issues cited by FDA for inspections from 2013 to 2015 were the lack of controls to prevent alterations of data by staff, failure to maintain records of accurate data, and delayed reporting of data.
Data integrity is fundamental in pharmaceutical manufacturing. It enables traceability of a batch to its origin and, more importantly, ensures that drugs are made and tested according to the required quality standards. It is, therefore, crucial that data records are accurate, complete, legible, attributable, intact, and maintained within their original context, including their relationship to secondary data records. Non-compliance does not only result in revenue loss for the violator due to facility shutdown, product recalls, import bans, and delayed or denied drug approvals, but it also tarnishes the company’s reputation and provides competitors with an opportunity to increase their market share. In addition, warning letters divert the attention of workers from their daily activities to corrective and preventive actions, which cost significant time and money.
According to Ernst & Young (2), one the key root causes of data integrity issues is staff shortage combined with excessive workload that lead to inaccurate and incomplete documentation; the emphasis on quantity over quality forces workers to compromise on quality so that production targets and dispatch timelines can be met. The lack of awareness among employees and ineffective training are also known to result in data integrity problems.
Regulators worldwide are increasingly focusing on data integrity in their enforcement efforts. Despite recent reports of Indian and Chinese companies receiving warning letters for data integrity violations, the problem is, in reality, a global one. The solution for the industry does not only involve changing its approach from reactive to proactive but embracing a culture of quality so that regulatory compliance becomes second nature in every company.
1. PwC, Health Research Institute Regulatory Spotlight, Data Integrity Problems A Growing Risk to Global Pharma Companies (March 2016), accessed 1 Apr. 2016.
2. Ernst & Young,
(June 2015), accessed 1 Apr. 2016.
Pharmaceutical Technology Europe
Vol. 28, No. 4
Citation: When referring to this article, please cite as A. Siew “The Repercussions of Data Integrity Violations,” Pharmaceutical Technology Europe 28 (4).