🏭 SOP for Good Manufacturing Practice (GMP) 1. Introduction Good Manufacturing Practice (GMP) is a quality system that ensures pharmaceutical products are consistently manufactured, controlled, and documented to meet specified quality standards appropriate for their intended use. It provides the framework to manage personnel, facilities, materials, processes, and records to prevent contamination, mix-ups, deviations, and errors throughout manufacturing and distribution. This SOP aligns with Schedule M (Drugs & Cosmetics Rules, India), WHO GMP, US FDA cGMP, and EU GMP requirements to support regulatory compliance and audit readiness. :contentReference[oaicite:1]{index=1} 2. Purpose To describe detailed step-by-step procedures for implementing, monitoring, recording, and maintaining Good Manufacturing Practices (GMP) to ensure product quality, safety, consistency, and regulatory compliance. :contentReference[oaicite:2]{index=2} 3. Scope Th...
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