Scope: This SOP defines the process for planning, conducting, following up, and closing audits using a risk-based approach to ensure compliance and continuous quality improvement.
 
The SOP includes:
A clear narrative of required action steps, ensuring consistency and compliance during inspections.
Defined roles and responsibilities for personnel, providing accountability at every stage.
 
 
Disclaimer: All SOPs provided by Quality Pharma are intended as general frameworks and templates. They are not “one-size-fits-all” documents. Each SOP must be reviewed, adapted, and approved within your organization’s Quality Management System (QMS) to ensure alignment with internal processes, applicable regulations, and specific operational needs. Quality Pharma is not responsible for regulatory outcomes resulting from the direct, unmodified use of these documents.