By William Porter

Published in: Research

Published on: October 1, 2022

The role of sampling and measurement uncertainty in assessing production process capability is examined, using content uniformity testing as an example. An expanded components of variance model is proposed for consideration during risk assessment and mitigation studies, with emphasis that either empirical (“top-down”) or model-based (“bottom-up”) approaches to estimation of uncertainty can be equally valuable in completing an expanded production process characterization (PPC) study.

Advance Stability Knowledge

Would you like to see a particular publication, guidance, organization, supplier, event, or career opportunity on StabilityHub? Contact us with your suggestion!