| Document | Purpose | | :--- | :--- | | | Describes the company’s Quality Management System (QMS), scope, exclusions, and interactions between processes. | | Quality Policy | A brief statement from top management about commitment to quality, safety, and regulatory compliance. | | Quality Objectives (KPIs) | Measurable goals (e.g., “Reduce deviation rate by 15% in FY24”) aligned with the quality policy. | | Site Master File (SMF) | Describes the pharmaceutical manufacturing site—facilities, equipment, personnel, and processes—for regulators. |