Certified Pharmaceutical GMP Professional Practice

How long must production, control, or distribution records be retained after the expiration date of drug components?

1. At least 1 year

2. At least 3 years

3. At least 5 years

4. At least 10 years

The correct answer is: At least 1 year

The correct duration for retaining production, control, or distribution records after the expiration date of drug components is at least 1 year. This requirement aligns with regulatory guidelines, which stipulate that records must be kept for a defined period to facilitate verification of compliance with good manufacturing practices (GMP) and to ensure product traceability. Maintaining records for at least 1 year post-expiration allows manufacturers and regulatory bodies to review historical data if issues arise, such as product recalls or adverse events related to the components. This brief retention period is often deemed sufficient to address potential concerns while balancing the need for efficient resource management within organizations. Longer retention periods specified in other options do not reflect the current regulatory requirements and may unnecessarily burden companies with storage and data maintenance obligations.