Standard Operating Procedure (SOP) for Handling and Investigation of Extraneous Peak(s) in Chromatography Analysis. What are the Extraneous Peaks: A peak response in the chromatogram that is not readily attributable…
Standard Operating Procedure (SOP) for reconciliation of packing materials and bulk at the end of the packing of each batch of Drug Product SOP for Reconciliation of Packing Materials 1.0 …
This SOP provides guidance to evaluate the potential of the proposed new product for cross-contamination and assessment of the containment approach required to manufacture the new product at Manufacturing and…