Certified Pharmaceutical GMP Professional Practice

What should be done if a significant discrepancy is found in a production record?

1. No action is required

2. Notify the shipping department

3. Investigate the discrepancy thoroughly

4. Submit the record for audit

The correct answer is: Investigate the discrepancy thoroughly

When a significant discrepancy is identified in a production record, a thorough investigation is essential to determine the root cause of the issue. This process involves analyzing the discrepancy to uncover any potential errors, lapses in protocol, or deviations from good manufacturing practices (GMP). Addressing discrepancies is critical for maintaining product quality, ensuring compliance with regulatory requirements, and preventing future occurrences. An effective investigation not only seeks to clarify what went wrong but also evaluates the impact of the discrepancy on product safety, efficacy, and regulatory compliance. Depending on the findings, corrective actions may be necessary, which could involve retraining staff, revising procedures, or implementing new controls. Investigating such discrepancies upholds the integrity of the production process and supports a culture of quality within the organization. In contrast, other options such as taking no action, notifying only the shipping department, or submitting the record for an audit would not sufficiently address the immediate concern posed by the discrepancy, potentially allowing unresolved issues to impact product quality and safety.