Line clearance risk assessment in secondary packaging areas

Product and labeling mix-ups can result in potentially serious consequences and are one of the top causes of recalls in the world. Therefore, manufacturers must pay particular attention and implement procedures to ensure that the correct medication and strength are in the correct container with the correct labels and instructions for use.

GMP rules require that measures are taken along the manufacturing chain to ensure that all products are correctly identified with the correct name, ingredients, strength, and batch information. Within secondary packaging areas, one of the activities that must be performed to ensure only materials suitable to the current batch are present in the working area is the line clearance (LC).

With the development and implementation of new technologies on packaging lines, LC is defined as one of the supporting processes that mitigate the occurrence of a mix-up.

This document gives guidance on using quality risk management principles to assess and control the risks associated with LC activities in packaging areas. It describes how to assess risks related to LC activities and guides the appropriate action if items not belonging to the running batch are identified, based on the related risk.