On January 15, 2021, GMP Trends® posted Issue #1056. In this issue, it states that the FDA found a Pharmaceutical manufacturer’s lab that was not recording data and other information properly for years. For starters, the equipment calibration and logbook were not updated for 18 months, the possession of the drug products were not tracked for the past year, along with many more areas of the quality system were not being tracked. The data in the lab was altered to continue the process of the drug product release. There was no guarantee that the information the lab was recording in the system was correct.
This illustrates that Data Integrity is a serious concern, especially when it comes to medications and what is being injected into one’s body. If a lab is not being honest with the outcome of the product testing, having the possibility of changing the data, then patients and practitioners could be receiving a contaminated, adulterated, or ineffective medication.
InQuest Science’s Identifier System is designed to prevent the ability of changing data information and violating Data Integrity. InQuest Science developed a data management system that evaluates product defect issues as well as particulate matter control throughout the product lifecycle. This system permanently records all data once submitted, and no alterations are allowed unless it has clearly described in the audit trail. This helps with control over drug defects and assurance of drug quality before the process of being released for distribution.
This system also improves information availability and builds trust during FDA inspections by allowing all the data to be imported onto one digital platform, minimizes the possibility of false data entries, and makes it clear of who is working on what task. Another area of bias and possible data integrity issues that can occur during human visual inspection qualification arises if the Test Sets are not fully blinded. Visual inspectors with knowledge of the test unit’s identity can falsify report the detection data during their qualification testing. InQuest has eliminated the issue by fully blinding the test sets with non-human readable bar or data matrix codes.
InQuest Science’s Identifier Software supports the UPS<790> Inspection routine and the USP<1790> guidance, aiming to improve the inspection process. www.inquestscience.com