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By Mark F. Witcher, Ph.D. | In the biopharma and medical device industries, operating procedures guide virtually every activity and are required for compliance with good manufacturing practices. Minimizing procedure execution failures is critical. To do so, you can use relational risk analysis (ReRA). |
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By Kalie E. Richardson, Hyman, Phelps & McNamara | A recent FDA final guidance interpreting the DSCSA details verification systems expectations for trading partners. Just how they should meet these expectations, however, remains unclear. |
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By A Walsh, et al. | The ASTM E55 Cleaning Team, in collaboration with F04 Medical Device Committee members, felt that the commonly used three-level criticality system was inadequate for use in a science- and risk-based standard for cleaning process development, validation, and monitoring. This article will provide a detailed discussion of how science-based and data-driven criticality levels were derived, the meaning of each level, and how they can be used for guiding the selection of risk reduction and risk control measures. |
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| Cell-Based Potency Assay In Functional Characterization Of mAbs | White Paper | By Agata Burzawa and Pamela Hamill, Ph.D., MilliporeSigma | Because characterization and comparison of originator and biosimilar candidate mAbs is challenging due to their complex and variable structures, a range of analytical techniques should be employed. |
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