Process analytical technology , guidance

This guidance is intended to describe a regulatory framework that the FDA chooses to call process analytical technology, or PAT. It is the FDA s hope that this will... 

Process analytical technology is consistent with the quality systems approach in that it is based on science and engineering principles for assessing and mitigating risks related to poor product and process quality. In the PAT guidance, the FDA indicates that the desired state for pharmaceutical manufacturing may be characterized as follows ... 

Multivariate analysis (MVA) is the statistical analysis of many variables at once. Many problems in the pharmaceutical industry are multivariate in nature. The importance of MVA has been recognized by the US FDA in the recent guidance on process analytical technology [3]. MVA has been made much easier with the development of inexpensive, fast computers, and powerful analytical software. Chemometrics is the statistical analysis of chemical data. Spectral data from modern instruments is fundamentally multivariate in character. Furthermore, the powerful statistical methods of chemometrics are essential for the analysis and application of spectral data including NIR and Raman. In this section, we will briefly review the subject of chemometrics and MVA. 

US Food and Drug Administration (2004) Guidance for industry process analytical technology-... 

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