Certified Pharmaceutical GMP Professional Practice

What should be done if a deviation from production procedures occurs?

1. Ignore it if there is no impact

2. Record and justify the deviation

3. Wait for a manager's approval

4. Notify the regulatory agency immediately

The correct answer is: Record and justify the deviation

When a deviation from production procedures occurs, it is crucial to record and justify the deviation. Documenting the deviation provides an accurate account of what happened, allowing for a thorough investigation into the root cause and potential impact on product quality and safety. This practice is essential for compliance with Good Manufacturing Practices (GMP) and helps ensure that corrective and preventive actions are taken to avoid future occurrences. Justifying the deviation involves evaluating its impact on the product and determining if it poses any risks to quality or safety. This assessment is necessary for making informed decisions regarding the disposition of the affected products and the overall production process. Proper documentation and justification create a transparent record that can be reviewed by quality assurance teams, auditors, and regulatory authorities, supporting the integrity and accountability of the manufacturing process. In contrast, ignoring the deviation, waiting for managerial approval, or notifying regulatory agencies immediately without assessment would not align with GMP protocols and might lead to significant risks in product quality and safety. Therefore, recording and justifying the deviation is the most appropriate response in compliance with established guidelines and regulatory expectations.