Pharmaceutical Quality Management System (QMS) Audit Checklist

A comprehensive checklist for auditing the Quality Management System in pharmaceutical organizations to ensure regulatory compliance and continuous improvement

Pharmaceutical Quality Management System (QMS) Audit Checklist
by: audit-now
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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 and objectives, document control, change management, corrective and preventive actions (CAPA), and management review processes. By systematically assessing your QMS against regulatory requirements and industry best practices, you can identify areas for improvement, ensure consistent product quality, and maintain compliance with Good Manufacturing Practice (GMP) standards. Regular use of this checklist helps pharmaceutical organizations foster a culture of quality, drive continuous improvement, and demonstrate their commitment to producing safe and effective medicinal products.

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Industry

Pharmaceuticals

Standard

FDA Food Code, HACCP

Workspaces

Pharmaceutical manufacturing facilities
Corporate offices
R&D centers

Occupations

Quality Assurance Manager
Compliance Officer
Quality Systems Specialist
Regulatory Affairs Director
Operations Manager

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