Shimadzu
Shimadzu is a world leader in the analytical instruments industry. Instruments include UHPLC, SFE/SFC, LC-MS/MS, GC-MS, UV-Vis, FTIR, MALDI-TOF, EDXRF, thermal analyzers, and TOC analyzers. They are used throughout the pharmaceutical pipeline, from proteomics and metabolomics research and drug discovery/development to QA/QC and manufacturing, providing a total solution to researchers working within the pharmaceutical/biopharma industry.
Shimadzu Scientific Instruments
7102 Riverwood Drive, Columbia, MD 21046
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tel. 800.477.1227 fax. 410.381.1222
Specification Equivalence—A Practical Approach
December 30th 2024In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.
