BioPharm International - July 2021

BioPharm - July 2021 - Biopharmaceutical Analysis

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Page 15 of 38 July 2021 BioPharm International eBook 15 Data Integrity Considerations for Vendor-Generated Data Associated with Analytical Testing Sponsors should consider best practices for maintaining data generated during sample analysis and instrument maintenance. T h is a r t ic le su mma r iz es a pha r maceut ica l industry consensus viewpoint of the current regulations regarding data integrity as applied to analytical test data generated to support regulatory activities. In particular, the focus will be on data generated by external personnel (e.g., a third-party laboratory or instrument service technician), hereafter referred to as a vendor. There are considerations for data integrity (1–4) when data are generated by a vendor. For example, analytical instrumentation (e.g., chromatographic, spectroscopic, spectrophotometric, thermogravimetric, electrochemical, or microscopy instrumentation) utilized in the pharmaceutical industry generates data not only during analytical sample analysis but also during routine or preventive maintenance, such as instrument calibration or qualification, and during troubleshooting associated with repairs. For preventive maintenance or repairs, data may be generated by company THOMAS CULLEN, CLIFF MITCHELL, JULIE LIPPKE, JOSEPH MONGILLO, KOOTTALA S. RAMASWAMY, AND THOMAS PURDUE gunayaliyeva - Biopharmaceutical Analysis Data Integrity T H O M A S C U L L E N ,* t h o m a s .f.c u l l e n @ a b b v i e.c o m , a n d C L I F F MITCHELL work in Analytical Research and Development at AbbVie Inc. (North Chicago, IL); JULIE LIPPKE and JOSEPH MONGILLO both work in Analytical Research and Development at Pfizer Inc. (Groton, CT ); KOOT TAL A S. R AMASWAMY works in Global Development Quality at Merck & Co., Inc. (West Point, PA); and THOMAS PURDUE wor k s in Qualit y at Boehring er Ing elheim Phar maceutic als Inc. (Ridgefield, CT ); all authors are members of the IQ Consor tium. *To whom all correspondence should be addressed.

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