Process analytical technology 490 Subject

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. 

Note Every effort has been made to ensure this list Is accurate, reliable, and Includes the most recent test methods available. Advances in analytical technologies and revisions to current test methods are an ongoing process. Therefore, due to the ever evolving test methods, the listed methods above may not be inclusive of all methods currently available. Also, it is possible the listed test methods are subject to revision (s) and may be replaced/superceded by a new test method(s). Thus, the reader should consult peer-reviewed documents before relying on the information provided. 

When the method development process has been completed, an analytical procedure is subject to validation and transfer to routine use. This process may be called technology transfer which implies migration from the R D environment to routine analytical laboratories. This process needs to be carried out whether the applicability of the procedure is limited to a single laboratory or to many laboratories. 

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