Pharmaceutical quality must be tested properly using pre-specified procedures, and the analytical data and test results obtained must be managed appropriately in accordance with good manufacturing practices (GMP), as specified in the Japanese Ministry of Health, Labour and Welfare Ordinance on Standards for Manufacturing Control and Quality Control for Drugs and Quasi-drugs. Furthermore, the United States Food and Drug Administration (FDA) and other agencies responsible for inspecting and investigating the pharmaceutical manufacturing industry require data integrity to ensure the reliability of pharmaceutical testing.
To certify that the tests themselves were performed properly, pharmaceutical companies must save analytical data, test records, instrument usage records, and so on, and manage the analytical data and test records in accordance with regulations on electronic records and electronic signatures specified by the FDA in 21 CFR Part 11.
The Report Set function in Shimadzu’s LabSolutions analytical data management system has helped improve the efficiency and ensure the reliability of such processes for HPLC and GC systems and has earned excellent reviews from pharmaceutical companies. However, Shimadzu also received many requests for expanding the scope of instrument models supported by the functionality. In response to such customer needs, Shimadzu now offers support for widely used spectrophotometers.