FDA 483 - Merck & Cie - November 02, 2018

An FDA inspection conducted at Merck & Cie, an API manufacturer located in Schaffhausen, Switzerland, from October 29 to November 2, 2018, identified a significant observation regarding the control of computer and related laboratory systems. The observation, detailed in a Form FDA 483, highlighted a lack of appropriate controls over data integrity within the Quality Control Chemical Analytics Laboratory. Specifically, the inspection revealed that laboratory personnel, including QC supervisors and managers responsible for the control and release of raw manufacturing data, were assigned 'Administrator' roles on HPLC and GC chromatographic systems. This level of access permitted them to edit or delete sequences, chromatographic data, and project folders without adequate oversight. Furthermore, the currently operating software, ChemStation (Rev. B.04.03), was found to be incapable of generating audit trails to capture changes made to electronic raw data from these critical laboratory systems. These findings indicate a vulnerability in the data integrity framework, potentially compromising the reliability and traceability of analytical results. Merck & Cie is expected to address these observations by implementing corrective actions to ensure robust data governance and system control.