Internal Audit and Self-Inspection Programme SOP
Internal auditing procedure for GMP/GDP.
3 200 Skr
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Purpose:
This SOP defines the planning, execution, documentation, reporting, and follow-up of internal audits and self-inspections performed to evaluate the effectiveness of the pharmaceutical quality system and compliance with regulatory requirements.
Regulatory Alignment:
EU GMP pharmaceutical quality system requirements, including expectations for self-inspection, independent review, and documented corrective actions.
Included Files:
• SOP – Internal Audit and Self-Inspection Programme
• Annual audit plan template
• Audit report and follow-up tracking templates
Format:
Microsoft Word (fully editable)
Intended Users:
Pharmaceutical companies, marketing authorisation holders, manufacturers, distributors, and quality assurance teams responsible for audit and self-inspection activities.