During related substances analysis, it becomes necessary to check the sample chromatogram with the actual chromatogram. But it is not possible to have printouts of chromatograms from previous analysis in cGMP lab environment.
How to have reference chromatograms for review purpose. What is the procedure. Is it allowed by regulatory agencies. Is there any mention about this requirement in regulatory guidelines.
Dear Ram,
We can take chromatogram for the forced degradation or precision from the Validation data and we can make include in Standard test Procedure for reference purpose.
Thanks
SK