Handling of Out of Trend (OOT) Analytical Test Results
Out of trend (OOT), results are those results that are within the specification but indicate that the particular analysis or process could be out of control. In case of stability…
SOP for Sampling of Raw Material
Standard Operating Procedure (SOP) for Sampling of Raw Material (API & Excipient) as per Schedule M and ICH Q7 (Good Manufacturing Practices Guideline). Raw Material sampling is the process of…
SOP for Working/Reference Standard Qualification
Standard Operating Procedure for Qualification, Handling and Usage Of Reference Standards, Calibration Standards, Impurity Standards, Working Standards, and Working Standard Solvents. SOP for Laboratory Standard Management 1.0 PURPOSE:…
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