Certified Pharmaceutical GMP Professional Practice

How must complaint files regarding drug products be maintained?

1. For 6 months after the complaint

2. For 1 year after the expiration or complaint date

3. Indefinitely

4. Until the product is re-evaluated

The correct answer is: For 1 year after the expiration or complaint date

The correct response emphasizes the regulatory requirement to maintain complaint files for a duration of one year after the expiration date of the drug product or one year after the complaint date, whichever is applicable. This time frame is essential for ensuring that any reported issues related to the safety, efficacy, or quality of drug products are adequately documented and can be reviewed for potential investigations or recalls. Maintaining records for this period is crucial for compliance with Good Manufacturing Practices (GMP) and for supporting the overall responsibility of manufacturers to monitor the safety and quality of their products post-marketing. This practice not only aids in addressing consumer safety concerns but also serves as an important part of any regulatory review or audit. The alternative options do not align with standard regulatory practices: maintaining records for only six months may not suffice, as issues might arise after this period; indefinite retention is impractical and not mandated unless specified by other regulations; and the suggestion to keep records only until re-evaluation could potentially result in loss of critical information that could impact product use or future regulatory scrutiny. Thus, the established guideline of one year post-expiration or complaint date is appropriate for effective quality assurance and regulatory compliance.