The below article was written for this blog by QA Manager, Zahra Khokher and our Associate Director of PV, Ejaz Butt. SOP Writing, Gap Analysis & Inspection Readines Background In the pharmaceutical industry, it is very important that a MAH has documented procedures in place in accordance with the regulatory requirements. This is a critical requirement in pharmacovigilance (PV) where patient safety is at risk if compliant procedures are not in place. From adverse event case m