In this chapter, we now extend our modeling to cases in which we want to represent our
processes as a series of steps. As we have already pointed out, the motivation for this is to …

This paper presents a case study in establishing the operation space of a Grignard reaction
in a continuous stirred tank reactor (CSTR). The operation space is the multivariate space …

During the development of a pharmaceutical chemical process, it is vital to establish a
control strategy that will ensure the process performance and fitness for use of the active …

Expedient risk assessment of aseptic manufacturing processes offers unique opportunities
for improved and sustained assurance of product quality. Contemporary risk assessments …

The objective of this article is to combine sound science with proven practical advice. Good
science requires stable process operations with low variation. It is good management to …

Collecting unit operation performance data on manufacturing processes has many benefits.
Besides assessing the health of assets, the data can also be analyzed to drive process …

Clinical trials constitute large, complex, and resource intensive activities for pharmaceutical
companies. Accurate prediction of patient enrollment would represent a major step forward …

Quality by design (QbD) is a significant initiative within the pharmaceutical industry at the
present time. It is based on the idea that most of the issues that are seen during the …

A near-infrared reflectance spectroscopic (NIRS) method was developed and validated for
the measurement of isopropyl alcohol (IPA) in loracarbef. A partial least-squares calibration …

The US Food and Drug Administration and the International Conference on Harmonization
have embraced the concept of building quality into pharmaceutical manufacturing processes. …