What is a traceability requirement in GMP?

• A. Ability to trace the color of packaging.
• B. The ability to identify lot numbers and track product through production and distribution for recall.
• C. Recording only batch numbers but not tracking.
• D. Keeping records of worker shifts.

Answer: (B)

Traceability in GMP means you can identify where a product and its ingredients came from and exactly where it has moved through processing and distribution, so you can pull a specific batch if a problem is found. This requires linking each product to its lot numbers and tracking that lot as it goes from raw materials through production, packaging, storage, and distribution. With this, if a contamination or defect is detected, only the affected lots are recalled, investigations can pinpoint the source, and customers are protected.

Color of packaging doesn’t provide traceability, so it isn’t the right focus. Recording only batch numbers without tracking movement leaves you unable to locate where the product has been or where it’s distributed. Keeping records of worker shifts relates to staffing and procedures, not the product’s traceable history.