Deviation and Non-Conformance Management SOP
Procedure for handling, documenting and investigating deviations
3 000 Skr
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Purpose:
This SOP defines the process for identification, documentation, investigation, classification, and closure of deviations and non-conformances that may impact product quality, regulatory compliance, or operations.
Regulatory Alignment:
EU GMP pharmaceutical quality system requirements, including expectations for deviation management, root cause investigation, and documented follow-up actions.
Included Files:
• SOP – Deviation and Non-Conformance Management
• Deviation and non-conformance report template
• Root cause analysis worksheet
Format:
Microsoft Word (fully editable)
Intended Users:
Pharmaceutical companies, marketing authorisation holders, manufacturers, distributors, and quality assurance teams responsible for quality event management.