When a biological product requires a specialized delivery device, the resulting combination product can introduce new types of quality evaluation. Product development brings together regulatory requirements for biologics and drug-delivery systems, and for many people on the biopharmaceutical side, that includes a number of unfamiliar terms, processes, and procedures. Among those are gauge repeatability and reproducibility studies for measuring variations that arise from measurement devices and the operators using them. This eBook introduces the concept of attribute-data gauge repeatability and reproducibility studies used for simple pass–fail assessments, which often are made visually by trained operators under study-director supervision.

In a manufacturing environment where traditional “silos” are being replaced by multidisciplinary teams, even process engineers on the drug-substance side need a basic understanding of what kinds of issues their drug-product–focused colleagues are dealing with. When delivery system development and manufacturing are outsourced — or the work is done by a partner with little experience in medical devices — you need to be able to speak the same language when discussing quality control concerns. And if you’re involved more closely, you need practical guidance for making seemingly subjective assessments work in a good manufacturing practice (GMP) environment.

This eBook provides just such advice from experts in the field of drug-delivery systems. It is part of our ongoing effort to bring perspectives from the former Institute for Validation Technology network into BPI. Look for more training-focused content in upcoming issues and online in 2023 and beyond.

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