Pharmaceutical Quality Management System (QMS) Audit Checklist

A comprehensive checklist for auditing pharmaceutical quality management systems, covering quality policy, risk management, change control, CAPA processes, and continuous improvement initiatives to ensure regulatory compliance and operational excellence.

Pharmaceutical Quality Management System (QMS) Audit Checklist
by: audit-now
4.7

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About This Checklist

The Pharmaceutical Quality Management System (QMS) Audit Checklist is a crucial tool for evaluating the effectiveness and compliance of a pharmaceutical company's quality management processes. This comprehensive checklist addresses key elements of a robust QMS, including quality policy, risk management, change control, corrective and preventive actions (CAPA), and continuous improvement initiatives. By systematically assessing the QMS, pharmaceutical organizations can ensure adherence to regulatory requirements, enhance product quality and safety, and foster a culture of quality throughout the organization. This checklist helps identify gaps in quality processes, ultimately contributing to improved operational efficiency and regulatory compliance.

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Industry

Pharmaceuticals

Standard

FDA Food Code, HACCP

Workspaces

Pharmaceutical Company Headquarters and Manufacturing Sites

Occupations

Quality Assurance Manager
Regulatory Affairs Specialist
QMS Auditor
Compliance Officer
Operations Manager

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