Case Study: Ensuring GMP-Compliant Weighing

​Spectral Service, an independent contract laboratory in Cologne, Germany, specializes in NMR spectroscopy, chromatography, and mass spectrometry. They offer comprehensive services for analyzing pharmaceuticals, food, and chemicals. One criterion the company must meet for GMP-compliant qNMR analyses is that the relative standard deviation, or RSD, of multiple results generated by the same analyst, must be within tight predefined limits. Spectral Service regularly evaluates the reproducibility of its analysts' results.

GMP-Compliant qNMR Results

Every analysis involves risks, which can affect results quality. METTLER TOLEDO's Good Weighing Practice™ (GWP^®) is helping Spectral Service to produce successful and accurate weighing by ensuring that the minimum weight of the balances the company uses is lower than the smallest amount of material an operator expects to weigh. A safety factor is also applied to compensate for fluctuations in minimum weight due to environmental variability or operator technique.
 

Eliminating qNMR Error Sources

Spectral Service's application of GWP, combined with its deep knowledge of weighing process requirements and best practices, now ensures that the RSD of their analysts' results lies between 0.1% and 0.3%. See how this elimination of an essential source of potential error for the company's final qNMR results is helping it to guarantee the quality of its customers' products.