Pharmaceutical Technology - March 2021

Pharmaceutical Technology - Regulatory Sourcebook - March 2021

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48 Pharmaceutical Technology REGULATORY SOURCEBOOK MARCH 2021 P h a r mTe c h . c o m Quality Collaboration B io/Pharma companies must embrace a culture of quality through drug discovery, development, and manufacturing phases; however, with many diverse functions in the pharmaceutical manu- facturing continuum, 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 indus- try to achieve quality standards for drug development 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 drug products. Over the past seven years, FDA inspection reports have revealed a pattern of repeated failure of facilities to follow data-integrity re- quirements established in current good manufacturing prac- tice (CGMP) predicate rules, regulations in 21 Code of Federal Regulations (CFR) 211, and other international regulations (1). The number of cited data integrity infractions indicated that bio/pharma facilities lacked a risk-assessment tool that could be used to ensure consistency when evaluating standalone R&D data-acquisition and processing software (1). 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. PAULISTA - STOCK.ADOBE.COM Collaborative Efforts Address Key Data Integrity Challenges Maintaining a quality culture across the diverse functions in a bio/pharmaceutical company is difficult. Representatives of the Quality Coordinating Committee of IQ Consortium report on collaborative efforts to address data integrity and the modernization of FDA's good laboratory practice regulations.

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