Producing cGMP biopharmaceutical products requires controlled, consistent performance of the manufacturing process. cGMP also requires controlled, consistent performance of analytical test methods.

This article is a condensed version of an article that appeared in the November/December 2022 issue of Chip Scale Review. Adapted with permission. Read the original ...

Evaluation methods rely on assumptions about how validation data and the data one wants to predict, called test data, are related. Traditional methods assume that validation data and test data are ...

Course Topics Include: – FDA, ICH and USP Validation Requirements – Applying Validation Studies Consistent with Method Purpose – GMP Compliance during Validation – Validation Acceptance Criteria – ...

As semiconductor devices continue to advance, the demand for reliable, high-performance test sockets has never been greater. Yet, traditional socket design validation methods—such as per-pin ...

The most probable number (MPN) bioburden test method can be a valuable tool for determining bioburden counts when the typical bioburden test methods are problematic on a particular product or when a ...