Validation refers to establishing documented evidence that a process or system, when operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes
Monday, January 1, 2018
Novel Analytical Methods to Verify Cleaning Process
The manufacturing suite used for pharmaceutical formulation is often not dedicated to one drug only. Manufacturers must be very careful during the switchover process to ensure that the active pharmaceutical ingredient (API) is completely flushed before moving on to the next formulation. Using charged aerosol detection with HPLC allows us to see every non-volatile that might be left behind. Chromatograms with individual peaks represent API residues in the tank and the peaks indicate concentration. For more information: http://chrom.ms/67ZFF6b
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