Certified Pharmaceutical GMP Professional Practice

What must be included in records of returned or salvaged drug products?

1. Storage conditions prior to return

2. Reason for return

3. Outcome of any product recalls

4. None of the above

The correct answer is: Outcome of any product recalls

The focus on including the outcome of any product recalls in the records of returned or salvaged drug products underscores the importance of tracking the safety and efficacy of pharmaceutical products throughout their lifecycle. Documenting the outcome of recalls provides critical information that can inform both regulatory compliance and overall product quality. This information can impact future decisions about the product's saleability, further investigations, and the determination of whether the drug can be released back into distribution after evaluation. Including the outcome of recalls in the records also serves to maintain a history of product safety and assists in audits or inspections. This history can be vital for regulatory bodies and helps to reinforce the commitment to patient safety, ensuring that any potential risks associated with a drug product can be adequately managed. In contrast, while factors such as storage conditions prior to return and the reasons for the return may provide valuable context, they do not carry the same weight in terms of regulatory compliance and public health implications as the outcomes of recalls. Thus, these elements alone, while important, do not reflect the comprehensive tracking needed for managing drug safety effectively.