Tools to Add A-TEEM Spectroscopy to a GMP Laboratory

A-TEEM spectroscopy is an emerging technique with huge potential for QC laboratories in the pharmaceutical and biopharmaceutical industries.

 

We present a set of tools for A-TEEM spectroscopy to help adopt the technique into labs that require Good Manufacturing Practices (GMP) and FDA regulations on instrumentation and electronic records for spectral data acquisitions and processing.

 

The Aqualog UV-800 A-TEEM spectrometer now has an OPC UA server called EzPAT, available for use in PAT enterprise software tools, making the move to GMP much easier. IQ/OQ process and procedures for instrument installation and operation validations make the operation of the instrumentation assured and the data reliable. A-TEEM Direktor is a new multivariate analysis software package that is built around the pharmaceutical industry needs and offers a guided workflow specific to A-TEEM data and modeling. The combination of these solutions help add the benefits of A-TEEM securely and easily into a GMP Laboratory.

 

Learning Objectives