Product and labeling mix-ups can have serious consequences and are some of the main causes of recalls. As a result, manufacturers must ensure that the correct medication and strength are in the right container with the correct labels and instructions for use.
GMP rules state there must be measures along the manufacturing chain to confirm that all products are clearly identified with the correct name, ingredients, strength, and batch information. In secondary packaging areas, line clearance (LC) is a critical activity that should ensure only materials suitable for the current batch are present in the working area.
Unfortunately, industry has not had an agreed method to assess the risks around LC activities and the actions needed if items are found that do not belong to the running batch.
BioPhorum’s new paper, Line clearance risk assessment in secondary packaging areas, will guide you on using Quality Risk Management principles to assess and control the risks associated with LC activities in your packaging areas.
After discussing the general LC process, the paper looks at the main principles when completing a risk assessment. It will help you evaluate the possibility of detecting a batch/product-specific item that has been overlooked during LC and if this might lead to a mix-up if the item is reintroduced to the line. The risk assessment defines the risks associated with the different LC activities and occurrences for a given packaging line.
“There is no doubt that LC is a critical process,” said Michelle Scharlé, Packaging Process Specialist at Novo Nordisk. “However, not all activities within LC pose the same risk to patient safety and product quality. Implementing BioPhorum’s Line Clearance Risk Assessment has enabled us to focus on the activities that pose risks to our patients instead of using valuable resources where we would see no improvement in the risk-benefit balance.”
But the paper covers more than just background and theory, it walks you through assessing the risks around the LC process and includes a traffic-light risk grid. It also talks about risk control and handling product-specific items found after your LC activities have been completed.
This all leads to the core of the paper – the LC risk assessment template. You can complete this as part of your own review, and it will take you through everything from process descriptions and the performance of LC to the detailed risk assessment and risk calculations. It also includes a table to help you evaluate your assessment results.
“The assessment has also helped us avoid lengthy discussions both internally and with our quality unit on how to classify and handle LC deviations,” Scharlé added. “Once the risks have been systematically assessed and documented, it is much easier to handle a specific case and focus on implementing effective corrective and preventive actions rather than discussing its classification.”
Helpfully, the template is already partially completed. Some text is explanatory and provides tips and suggestions, but there is also some ‘suggested text’ that can be adopted, adapted, modified, or amended as needed. With the increasing use of new technologies on packaging lines, LC is one of the supporting processes that reduces the risk of mix-ups. This BioPhorum paper will not only help you identify the risks in your LC process, but also help to do something about them.