These define the organization's quality philosophy and broad commitments to regulatory bodies like the FDA, EMA, or WHO.
| Document Type | Description | |---------------|-------------| | | A high-level document outlining the company’s quality policy, objectives, and scope of the Quality Management System (QMS). | | Quality Policy | A statement of intent from executive management regarding commitment to quality and compliance. | | Quality Plan | A document specifying procedures, resources, and activities to achieve quality objectives for a specific product or project. | | Site Master File (SMF) | A document describing the pharmaceutical manufacturer’s production site, facilities, equipment, and quality system (required for regulatory inspections). | list of qa documents in pharmaceutical industry
Change Control Records
A management-level statement of the company’s quality intentions and commitments. These define the organization's quality philosophy and broad
| Document | Description | |----------|-------------| | | Requests a change to a validated process, equipment, or material (with impact assessment). | | Deviation Report / Incident Report | Documents any departure from approved procedures or specifications. | | Corrective and Preventive Action (CAPA) Form | Investigates root cause of deviations and defines actions to prevent recurrence. | | Out of Specification (OOS) Investigation Report | A formal investigation when a test result falls outside specification limits. | | | Quality Plan | A document specifying
Remember: Documents are not red tape; they are the only proof that a patient received a safe, effective product. Treat your document inventory with the same rigor as your chemistry.