On November 15, 2020 GMP Trends® posted Issue #1052. In this issue, it explains how this manufacturer violated data integrity, and provided incomplete/ inaccurate data throughout the inspection; not recording data properly. This report provides information on the many improper actions this manufacturer contributed to; such as equipment not having documentation or validation, data failed to be backed up, as well as having incorrect entries.
SOP (Standard Operation Procedure) requires data information to be documented at the same time the work is being performed. During the walk-through, Inspectors noticed that Lab Technicians were writing in data two days after testing was completed; management in the lab had prior knowledge of this, but did not make any changes in their work environment. Following SOP is very important with the process of creating drugs. InQuest Science’s new Identifier System, makes it impossible for incidents like this. This system makes data importing clear, following all SOP requirements, in addition to keeping all data current and convenient to access. It guides manufactures to import data properly, without allowing adjustments and making it hard to provide false data on products. This will reduce the chances of having drug recalls, and 483 warning letters due to violating data integrity.
In addition, this manufacturer failed to maintain a backup file. Proving that nothing was entered in a computer system that saves data information permanently; this goes against SOP guidelines—that require a full backup of data in a system. It is mandatory that backups are to be performed on a regular basis to prevent data alterations/ duplication that could happen when doing paperwork. In this investigation, the manufacture only had one source of data information and it came from handwritten paperwork. There are multiple unknown factors about this data without a backup.
InQuest Science’s Identifier System will solve issues involving back-up data, Standard Operation Procedures, recording your data, data integrity, particle defects and visual inspection. The Identifier software will help drug manufactures keep track of all data by importing all products, defects, qualifications, visual inspections, and more. It also supports USP<790> Inspection routine and the USP<1790> guidance, aiming to improve the Inspection process.
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