Management Review of the Pharmaceutical Quality System SOP
Procedure for QMS performance evaluation.
2 800 Skr
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Purpose:
This SOP defines the requirements for the planning, conduct, documentation, and follow-up of periodic management reviews to assess the performance, effectiveness, and suitability of the pharmaceutical quality system.
Regulatory Alignment:
EU GMP pharmaceutical quality system requirements, including expectations for management responsibility, quality oversight, and continuous improvement.
Included Files:
• SOP – Management Review of the Pharmaceutical Quality System
• Management review agenda template
• Management review minutes and action tracking templates
Format:
Microsoft Word (fully editable)
Intended Users:
Senior management, quality assurance leadership, and responsible persons involved in oversight of the pharmaceutical quality system.