Lane Qualification and Continuous Monitoring

Vice President of Sales - Micalyn Harris and Team Leader of GMP Services Dr. Michael R÷hrig at ELPRO data monitoring solutions discuss the concept of Lane Qualification vs Continuous Monitoring

How are you approaching lane qualification currently?

We see lane qualification as part of transport validation concept, developed by a quality risk analysis approach and summarized in a validation master plan (VMP). It includes lane definition, analysis, and grouping during DQ and IQ, and the qualification of all utilities and equipments during OQ. Finally, a statistical relevant number of tests is run along the complete supply chain during PQ, which includes lane qualification. The number of tests needed is determined risk based and depends on the complexity of the lane. For worldwide supply chains with all possible combinations of seasons at shipping point and destination, we see a full set of one year's data as statistically relevant.

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We provide the customer the possibility to collect and manage the right data needed to conduct the analysis for lane qualification during PQ through a combination of data loggers and central database. There are several ways in which we can collect the data, including ERP integration or entry directly onto the data logger. From there the data is searchable and reportable for lane analysis. All parts of the transport validation approach can be supported by our GDP Services team , either by consulting services, or directly performing the qualification and analysis work.

Do you think a combination of both lane qualification and continuous monitoring is always needed or are there cases where one could be more suitable than the other?

From the regulatory perspective, the inspectors want to see pre-shipping risk assessments and qualified lanes. Continuous monitoring as a term is not part of the USP 1079 regulations yet, but under discussion for future publication under 1083.2. It is already required according to EU GDP guideline chapter released late 2013. Transport validation will be part of the EU GMP Annex 15 (Qualification and Validation) which is expected to go live in October 2015.

To qualify lanes you need the data from continuous monitoring. After successful lane qualification, then it could be possible to take a risk-based approach to reduced monitoring as long as the data and product stability supports it. If a lane analysis hasn’t been performed, or perhaps not enough data is available to take a risk-based decision, then regulators are going to require monitoring. From a business perspective, if the drug manufacturer is moving high-value goods, they are more likely to monitor that shipment than use a risk-based approach that doesn’t monitor every shipment. To that end, lane qualification can support a reduction in continuous monitoring, but with regards to current and up-coming regulations both lane qualification and monitoring will be required to ensure patient safety.

What do the concepts of lane qualification and continuous monitoring mean to you?

Continuous monitoring seems to be a new term in cold chain, and our customers talk more about collecting time stamped data throughout their supply chain . For ELPRO, continuous monitoring in cold chain distribution is compliant monitoring that specific shipment from point A to B using a data logger as it records continuously based on the interval you set at the sending site. In other applications it could mean real time, or 24/7 data collection (such as in facility or equipment monitoring with a Central Monitoring System).

ELPRO thinks of lane qualification as part of a risk based transport validation approach- collecting the right data pertinent to the lane and then analyzing that data to look for trends and make improvements.

What are the main challenges facing those conducting lane qualifications and or continuous monitoring within cold chain?

The usability of the data, internal resources, and know-how are the most common reasons lane qualifications can be difficult. First you have to have collected enough data, ELPRO recommends over the course of at least one year, for that particular lane to be able to create some meaningful statistics. Our customers use liberoMANAGER, a cloud SaaS platform to collect the data. But even once the data is there in a central location, customers can be challenged with resources to conduct the analysis or having the right tools for analysis and trending. Also at times, the data is not in a usable format if the customer has over the course of that year used different devices or saved data in different locations.

For continuous monitoring, if we are talking about it in terms of use of data loggers, then the challenges are throughout the supply chain, and you could spend an entire day talking about shipping challenges. This can be as simple as getting the reports back from the receivers, or having the reports in an organized, searchable format. An example of a more complex challenge is how to monitor and release a multi-component shipment (i.e. clinical shipment with an IMP and comparator). Another challenge is how to store data and release shipments for a multi-data logger shipment, with the issue being if one of the data loggers alarms but not the others.

On top of all this, there is an inherent difference between pharma and logistics partners. Pharma by nature are chemical engineers and manufacturers, governed in every move they make. Each process has to be validated through series of testing. Whereas supply chain partners want to simplify processes, if possible have a neat checklist to get things done. These two different perspectives, let’s call it two different languages the businesses speak, can also create challenges in making decisions around lane qualifications and monitoring.

ABOUT ELPRO

As long-term partners for nearly 30 years with large and other sized biopharma companies, ELPRO has worked deeply in developing cold chain processes. Lately that has included qualifications of lanes, boxes, or partners using a central database approach. We have a GDP validation team with the expertise to analyze the data and make recommendations.