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36 BioPharm International eBook March 2021 www.biopharminternational.com Collaborative Efforts Address Key Data Integrity Challenges Collaborative efforts address data integrity and the modernization of FDA's good laboratory practice regulations. B io/pharma companies must embrace a cul- ture of quality through drug discovery, development, and manufacturing phases; however, with many diverse functions in the pharmaceutical manufacturing contin- uum, cutting across geographic regions, achieving a uniform quality culture is challenging. Data integrity—once limited to narrow functions—is now a priority across bio/pharmaceutical organizations and is under close scrutiny by regulatory authorities. Adding to the complexity is a lack of consensus between regulatory authorities on some standards of practice for data integrity and other quality issues. Recognizing the need for expert insight and discussion on quality disciplines for the global bio/pharmaceutical industry to achieve quality standards for drug devel- opment and manufacturing, the Quality Leadership Group (QLG) of the IQ Consortium formed a Quality Coordinating Committee (QCC). With a global view on compliance, the QCC bridges good laboratory practice and good manufacturing practice disciplines, integrates quality efforts with the technical and scientific activities of other working groups, and establishes a framework to address quality concerns for other areas such as good clinical practices. In recent years, the group has addressed two pertinent issues, data integrity and the modernization of FDA's good laboratory practice (GLP) regulations. DATA INTEGRITY THROUGHOUT THE GMP LIFECYCLE The integrity of data used for science-based decision making is integral to the quality, efficacy, and safety of Paulista - Stock.adobe.com Ganapathy Mohan, Christopher Turner, Dennis O'Connor, Lisa Fink, Thomas Purdue, Jeffrey Beebie, Kerri Robles, and Karen Waetjen; all authors are members of the IQ Consortium. Regulatory Sourcebook Quality Collaboration