Certified Pharmaceutical GMP Professional Practice

Which information is NOT required in distribution records?

1. Name and strength of the product

2. Details of the shipping agent

3. Date and quantity shipped

4. Lot number of the drug product

The correct answer is: Details of the shipping agent

Distribution records are a critical part of Good Manufacturing Practices (GMP) in the pharmaceutical industry as they ensure the proper tracking of drug products throughout the supply chain. The requirement for specific information in distribution records is outlined in various regulations and guidelines to maintain product integrity and traceability. The inclusion of the name and strength of the product, the date and quantity shipped, and the lot number of the drug product is essential for identifying what was shipped, when it was shipped, and which specific batch of the product is involved. This information is crucial for ensuring product safety, facilitating recalls if necessary, and maintaining comprehensive records for regulatory compliance. In contrast, while the details of the shipping agent can be relevant for internal logistics and tracking purposes, it is not a stipulated requirement in distribution records focused on the product itself. Therefore, it is acceptable to omit the shipping agent's details from these records, as the emphasis is primarily on the drugs being distributed rather than the entities transporting them.