Agilent HPLC – Operation & Calibration SOP

uidance is provided on general procedure applicable for operation and calibration of High Performance Liquid Chromatography (HPLC) taking Agilent HPLC Infinity Series (Quaternary Channel) system as an example. Parameters to…

Continue ReadingAgilent HPLC – Operation & Calibration SOP

Quality Metrics – New FDA Guideline

The term “Quality Metrics” means all those indicators that give an idea of ​​the collective quality characteristics of a certain production site. The number of rejected batches per year compared…

Continue ReadingQuality Metrics – New FDA Guideline

Infrastructure Qualification Procedure – Quality IT

Standard Operating Procedure (SOP) for IT Infrastructure Qualification of Computer System used in cGxP environment at the pharmaceutical company. Computer System - IT Infrastructure Qualification 1.0   Objective  This Procedure defines…

Continue ReadingInfrastructure Qualification Procedure – Quality IT