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…
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…
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…
Standard Operating Procedure for Dispensing of Raw Material (API-Active Pharmaceutical Ingredient and Excipient) to the production department for the manufacturing of pharmaceutical drug products. 1.0 PURPOSE: The…