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Dear Sudiptu and Rafel,
Thanks for the information. But now a days, all sponsor are asking to set the same integration parameters in the all analytical batches of study, which were used in the method validation.
So it is suggested to add, all integration parameters in the Method SOP (molecule specific SOP) after completion of method validation and the same will be( must be) used for study.
In the ANVISA guideline "Resolution - RE no 895, of May 29, 2003", section No. 18.104.22.168, they have asked the integration parameters in the SOP.
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