A validation concept for purity determination and assay in the pharmaceutical industry using measurement uncertainty and statistical process control |
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Authors: | Stephan Küppers |
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Institution: | (1) Schering AG, In-Prozess-Analytik, Müllerstrasse 170–178, D-13342 Berlin, Germany Tel.: +49 30-468 17819 Fax: +49 30-468 97819 e-mail: Stephan.Kueppers@Schering.de, DE |
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Abstract: | The analytical chemists in process development in the pharmaceutical industry have to solve the difficult problem of producing
high quality methods for purity determination and assay within a short time without a clear definition of the substance to
be analyzed. Therefore the quality management is very difficult. The ideal situation would be that every method is validated
before use. This is not possible because this would delay the development process. A process-type quality development approach
with an estimation type fast validation (measurement uncertainty) is therefore suggested. The quality management process consists
of the estimation of measurement uncertainty for early project status. Statistical process control (SPC) is started directly
after measurement uncertainty estimation and a classical validation for the end of the project. By this approach a process
is defined that allows a fast and cost-efficient way of supporting the development process with the appropriate quality at
the end of the process and provides the transparency needed in the development process. The procedure presented tries to solve
the problem of the parallelism between the two development processes (chemical and analytical development) by speeding up
the analytical development process initially.
Received: 25 March 1997 · Accepted: 17 May 1997 |
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Keywords: | Analytical quality Measurement uncertainty Statistical process control Quality process |
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