Characterization of the parent compound is important and required prior to initiating any toxicological and analytical study. This information could be in the form of mass spectra, NMR data and chromatographic analysis. While characterizing the main component it is advisable to know details about related impurities, their abundance and their relevance. Depending on the nature of impurity, different approaches have been developed, published and followed to characterize them quantitatively or qualitatively. To prove the toxicological relevance of an impurity, profiling may include biological testing as well as analytical characterization. Analytical impurity profiling is conducted using a wide range of sophisticated equipment, data processing tools, and traceable reference standards. In toxicological studies, control of the biological test system is important, whereas analytical characterization has its own challenges in terms of operation, maintenance, calibration and monitoring of modern equipment. The main concern for regulators and GLP authorities all over the world is the integrity of data generated by automated equipment. Therefore, it is equally important to focus on the GLP aspects of the whole process, starting from receipt of impurity till archiving and retention of data. Overcoming the risk factors and the challenges associated with the generation of analytical data requires insight and a proactive attitude on behalf of the study director and the quality assurance auditor. In GLP studies, it is of prime importance to identify each critical phase and establish a detailed protocol and auditing scheme for various types of analytical studies. This presentation will emphasize best practices for planning, performing, recording, reporting, and archiving of analytical impurity profile studies in full adherence of GLP requirements.

Planning, performing, recording, reporting and archiving of analytical impurity profiling studies in compliance with principles of GLP

256th National Meeting (2018)

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