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Sponsors should consider best practices for maintaining data generated during sample analysis and instrument maintenance.
This article summarizes a pharmaceutical 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 is on data generated by external personnel (e.g., a third-party laboratory or instrument service technician), referred to as vendors.
Analytical instrumentation used 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. The various scenarios under which outsourced data may be generated and managed are discussed.
Thomas Cullen*, email@example.com, and Cliff 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); Koottala S. Ramaswamy works in Global Development Quality at Merck & Co., Inc. (West Point, PA); and Thomas Purdue works in Quality at Boehringer Ingelheim Pharmaceuticals Inc. (Ridgefield, CT); all authors are members of the IQ Consortium.
*To whom all correspondence should be addressed
eBook: Biopharmaceutical Analysis, July 2021
When referring to this article, please cite it as T. Cullen, C. Mitchell, J. Lippke, J. Mongillo, K.S. Ramaswamy, and T. Purdue, “Data Integrity Considerations for Vendor-Generated Data Associated with Analytical Testing," BioPharm International Biopharmaceutical Analysis eBook (July 2021).