Ensure Risk Assessment Precedes Any Change in Manufacturing Process

Remember: Never initiate process changes without first conducting a documented risk assessment.

Why This Matters in GMP

In the pharmaceutical industry, even minor changes to a manufacturing process can have significant consequences. A change that appears harmless may introduce variability, compromise product quality, or affect patient safety. Conducting a thorough risk assessment before implementing any change helps identify potential hazards, evaluate their impact, and determine appropriate control measures. It ensures that the proposed change is well understood, justified, and managed through a structured approach. Without this evaluation, manufacturers risk introducing deviations, triggering batch rejections, or failing GMP audits. For example, changing a mixing time without validating its impact could affect drug uniformity. Risk assessments align with a proactive quality culture and help ensure consistency, traceability, and regulatory compliance.

Regulatory and Compliance Implications

Global regulatory bodies such as the FDA (21 CFR Part 211), EU GMP Annex 15, and WHO GMP guidelines mandate a formal change control system that includes risk evaluation. ICH Q9 explicitly emphasizes the use of risk management principles in pharmaceutical quality systems. Skipping or inadequately performing risk assessments may lead to audit observations, warning letters, or product recalls. Regulatory authorities expect firms to demonstrate how a change was assessed, approved, and implemented with minimal impact. The risk assessment should be linked to the change control documentation, supported by scientific rationale, and reviewed by QA. Documentation must be complete, with clear identification of risks, mitigation actions, and follow-up requirements to ensure continued GMP compliance.

Implementation Best Practices

To embed risk assessment into your change management system:

• Develop a standard template for risk assessment using tools like FMEA or Ishikawa diagrams.
• Train cross-functional teams (QA, production, engineering, QC) on risk identification and prioritization.
• Ensure each change control record includes a risk assessment signed by relevant stakeholders.
• Use historical deviation data and CAPA trends to inform risk decisions.
• Periodically review completed assessments to improve future evaluations and reduce blind spots.

Regulatory References

• FDA 21 CFR Part 211 – Subpart F: Production and Process Controls
• EU GMP Annex 15 – Qualification and Validation
• ICH Q9 – Quality Risk Management
• WHO Technical Report Series No. 981 – Annex 2: GMP for Pharmaceutical Products
• Schedule M – Requirements of Premises, Plant and Equipment for Pharmaceutical Products