Quality Risk Management SOP (ICH Q9)
Risk assessment framework with FMEA templates.
3 800 Skr
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Purpose:
This SOP defines the methodology and governance for identifying, assessing, controlling, communicating, and reviewing risks that may impact product quality, patient safety, or regulatory compliance.
Regulatory Alignment:
ICH Q9 Quality Risk Management principles and EU GMP risk-based quality system expectations.
Included Files:
• SOP – Quality Risk Management
• Risk assessment and risk register templates
• Example risk evaluation tools (e.g. FMEA-style framework)
Format:
Microsoft Word (fully editable)
Intended Users:
Pharmaceutical companies, marketing authorisation holders, manufacturers, distributors, and quality assurance teams responsible for applying risk-based decision-making.