Chris Burgess

Data governance, data integrity, and data quality are all widely used terms, but what do they actually mean and how are they connected?

Different methods to calculate limits for impurities will give different answers. The prediction interval method may be ideal.

A simplified process flow with associated definitions for pharmaceutical sampling and testing is proposed.

Inconsistent sampling and testing processes can lead to errors, resulting in data integrity issues and potentially incorrect decisions about pharmaceutical quality.

Analysts should understand how a monograph, together with the associated general notices and general chapters, relate to their responsibilities under good manufacturing practices.

This article looks at a simple structured approach to assigning variance contributions and to assuring that the analytical procedure is fit for purpose.

Performing a measurement uncertainty calculation is often seen as problematic.

A risk-based guard band surrounds a specification limit and is derived from the uncertainty of the reportable value of the analytical procedure, which includes the uncertainty in the reference standard. The author discusses requirements for generating a reportable value and calculating the associated measurement uncertainty.

This article takes a statistical look at the calibration requirements for a UV spectrometer.

How good is a reportable value?

The author discusses the purpose of analysis and testing and the implications for specifications and their underlying statistical distribution.