Regulating manufacturing processes in the medical device industry is challenging. But process signature verification can help manufacturers get a handle on problems before they get out of control.

The manufacturing process is a complex one that can be impacted by many factors: supplies, equipment, factory overhead, the need for special parts, and the people who work at all points in the process ...

An important aspect of Quality by Design (QbD) is to establish meaningful and realistic specifications. Well-defined specifications control the performance of products, as they derive from ...

Process design experimental data and risk assessments are used to predict expected process performance and establish process performance qualification acceptance criteria. Per ICH Q8, the aim of ...

The authors outline a validation approach for the manufacture of a “legacy product,” taking into consideration recent guidelines. The aim is to demonstrate the validity and capacity of the ...