However, even with hardcopy data, the validity of the data was directly impacted by the integrity of the bench chemist and laboratory management’s commitment to ensure the complete and accurate data is recorded. For decades, the documented hardcopy laboratory data in bound notebooks was reviewed and any discrepancy in the data was easily detectable and could be questioned. In the absence of managements support of a quality culture, quality systems can break down and lead to CGMP noncompliance.” This passage directs company management to take the responsibility to create a quality culture, which, in turn, should result in robust laboratory documentation processes and practices that will assure the integrity of laboratory data. It is the role of management with executive responsibility to create a quality culture where employees understand that data integrity is an organizational core value and employees are encouraged to identify and promptly report data integrity issues. One passage in the introduction of the guidance has resonated with me: “Management’s involvement in and influence on these strategies is essential in preventing and correcting conditions that can lead to data integrity problems. Since the initial April 2016 draft published, the pharmaceutical industry has been working to toward complying with the FDA guidance on Data Integrity and Compliance With Drug CGMP ( here) which was finalized in December 2018.
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