What may be included in the documentation for traceability?

The documentation for traceability primarily focuses on the ability to track the history, application, or location of an item or activity through recorded identifiers. This is crucial in the pharmaceutical industry to ensure accountability and compliance with regulatory requirements. Records of production and shipment play a significant role in this context, as they provide a clear and detailed account of the materials used in the manufacturing process, the batch or lot numbers assigned, and the subsequent distribution of the finished products. Such documentation allows for quick identification in the event of a product recall or quality issue, ensuring that affected products can be efficiently traced back to their origin.

Employee performance reviews, supplier price lists, and market research data do not serve the same function regarding traceability. They are important in different contexts within a GMP framework, such as human resources and procurement, but they do not directly contribute to the ability to trace materials and products throughout the production and distribution process. Therefore, the inclusion of production and shipment records is vital for establishing and maintaining effective traceability in the pharmaceutical manufacturing environment.