USP Publishes Revised General Chapter on NIR and Takes Account of the Increased Use of NIR in PAT

GMP News
16 August 2007
 

USP Publishes Revised General Chapter on NIR and Takes Account of the Increased Use of NIR in PAT

 
In the July/August 2007 issue of the Pharmacopeial Forum, the USP presents the revised General Chapter <1119> "Near-Infrared Spectroscopy", which is meant to be included in USP 31/2008.
 
The General Chapter on Near-Infrared Spectroscopy was completely revised in order to make it clearer and better comprehensible. And the chapter was adapted to the present-day implementations of NIR in the pharmaceutical industry. On the whole, it was also an objective that the chapter should take account of the increased usage of NIR in PAT (Process Analytical Technology) implementations. Furthermore, some changes have been suggested for the qualification of NIR instruments, especially regarding the subsection "Wavelength Unvcertainty".

A new section in the chapter is titled "Outliers". The text says that an NIR response that is not incorporated into qualitative or quantitative calibration models does not necessarily indicate an out-of-specification result. If an outlier occurs in an NIR measurement, the consequence must rather be that further tests are conducted on the sample by means of adequate methods. In case these additional tests show that the sample lies within the required specifications, the sample is acceptable.

These days, the General Chapters Expert Committee Advisory Panel of the USP is also working on the following two General Chapters:

<1038> Chemical Imaging
<1039> Chemometrics
 

2 FDA Speakers at the PAT Conference of the University of Heidelberg
 
The use of NIR in PAT projects is one of the focus topics of the PAT Conference 2007 held by the University of Heidelberg in Heidelberg from 24-26 October 2007. Among the speakers is Dr John A. Spencer from the FDA, Division of Pharmaceutical Analysis, St. Louis, USA, who had drawn up the first draft of the original USP Chapter <1119> - Near-Infrared Spectrophotometry and who has since been involved in the revisions of this chapter. At the PAT Conference 2007, he will lecture about Terahertz Spectroscopy at FDA. The complete programme of the PAT Conference can be found at www.pat-conference.org.

 
Author:
Dr Günter Brendelberger
On behalf of the European Compliance Academy (ECA)
 

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