By Ashley Ruth, Senior Consultant, Analytical Services, BioTechLogic
The pharmaceutical and biopharmaceutical industries must give immediate and strategic consideration to data integrity practices for two critical reasons: 1. increased attention to data integrity shortcomings by global regulatory agencies and 2. the possibility of a less stringent regulatory environment.
To understand the pressing ramifications of this issue, we must remind ourselves that data is both the backbone of CGMP compliance and the fuel of the digital economy. In the pursuit of increased efficiency, digital approaches are being used for risk reduction and greater innovation in pharmaceutical lifecycle processes—from discovery to commercial manufacturing—and must continue to be further leveraged. Additionally, data must become less siloed and flow much more seamlessly throughout pharmaceutical organizations at various stages of the product lifecycle. However, just as if gasoline in a car engine is contaminated, it will damage and/or cease the engine, the same is true for “digital fuel.” Correct and uncorrupted data must flow through a pharmaceutical organization so that correct and reliable decisions can be made. Even without sophisticated digital data management considerations, the integrity of even the most basic data systems must be assured to ensure compliance.
Regulators Increased Attention to Data Integrity
For several years, the FDA and other global regulatory bodies have emphasized the importance of accurate and reliable data in assuring drug safety and quality. However, in tandem with increased digital sophistication and the role of global manufacturing partners, integrity violations have been on the rise.
As a reflection of the importance of this issue, in April, 2016, the FDA released draft guidance, “Data Integrity and Compliance With CGMP Guidance for Industry.” Within the guidance itself, the FDA notes the trend of increasing violations.
The guidance states, “In recent years, FDA has increasingly observed CGMP violations involving data integrity during CGMP inspections. This is troubling because ensuring data integrity is an important component of the industry’s responsibility to ensure the safety, efficacy, and quality of drugs and of FDA’s ability to protect public health. These integrity-related CGMP violations have led to numerous regulatory actions, including warning letters, import alerts, and consent decrees.”
