Data Integrity Considerations for Vendor-Generated Data Associated with Analytical Testing
Publication
Article
BioPharm InternationalBioPharm International, 2021 Biopharmaceutical Analysis eBook
Volume 2021 eBook
Issue 3
Pages: 15–19
Sponsors should consider best practices for maintaining data generated during sample analysis and instrument maintenance.
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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.
Read this article in BioPharm International’s July 2021 Biopharmaceutical Analysis eBook.
About the authors
Thomas Cullen*, thomas.f.cullen@abbvie.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
Article Details
BioPharm International
eBook: Biopharmaceutical Analysis, July 2021
July 2021
Pages: 15–19
Citation
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).
Articles in this issue
Complex Biomolecules Require Analytical Evolution
Best Practices for Analytical Method Validation: Study Design, Analysis, and Acceptance Criteria
Data Integrity Considerations for Vendor-Generated Data Associated with Analytical Testing
Detecting Residual HCPs Demands a Holistic Approach
Increasing the Depth and Reliability of HCP Analysis Using TIMS-MS
Improving IR Spectroscopy as a Tool for Biopharmaceutical Analysis
Prioritizing Cleaning Validation
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