Certified Pharmaceutical GMP Professional Practice

What records should be maintained for returned drug products?

1. Name and label potency, lot number, reason for return

2. Expiration date, batch number, inspection report

3. Supplier information, storage conditions, testing results

4. Quantity sold, distribution records, customer complaints

The correct answer is: Name and label potency, lot number, reason for return

Maintaining accurate records for returned drug products is critical for ensuring patient safety and adhering to regulatory requirements. The chosen answer includes essential elements that provide a comprehensive overview of the returned product. Recording the name and label potency is vital as it identifies the specific product and confirms its intended strength and dosage form. The lot number is crucial for tracing the product back to its production batch, which can be necessary for identifying any widespread quality issues or recalls associated with that specific batch. Documenting the reason for the return is equally important, as it helps in identifying patterns that may indicate problems with the product itself or its handling, thereby assisting in future quality assurance and risk management efforts. The other listed choices contain data that, while valuable in other contexts, do not capture the core requirements for effectively managing returned drug products. For instance, expiration dates and inspection reports are more relevant to items still in inventory or for quality control rather than specifically tracking returns. Similarly, details like supplier information and storage conditions primarily pertain to procurement and storage protocols but do not directly address the specifics of returned product handling. Additionally, quantity sold and distribution records are useful for inventory management, but they fail to provide the detailed insights required for assessing and processing returned items.