Description

Pharmaffairs conducts a detailed Gap Analysis to assess compliance with cGMP norms, Schedule M, and WHO-GMP standards. Our team performs a comprehensive facility review covering personnel and material movement, spatial design, and documentation systems across all departments—QA, QC, Production, Warehouse, Utilities, and HR. Based on the findings, we provide stepwise recommendations for facility layout revision, equipment needs, and documentation upgrades. We assist in preparing and maintaining essential regulatory records including SOPs, BMRs, MFRs, MPRs, and validation protocols, ensuring alignment with global quality systems. Support includes stability studies, product recall, complaint handling, and self-audit preparation for external inspections.