The Need for Change and Collaboration within the Cold Chain Shipment Industry
BioPhorum share a teaser of their upcoming best practices for biopharmaceutical manufacturers and suppliers
When it comes to qualifying shipping lanes or Thermal Protection Systems, each pharmaceutical company has a different set of standards. This leads to almost no consistency across the industry.
Vendors and suppliers of transport equipment also have the additional challenge of lacking a standard to include within the specific tests that customers require. This often leads to a huge amount of resources dedicated to qualifying shipping lanes, where work is unnecessarily repeated and existing data is not leveraged.
The benefits of increased industry collaboration
Under the BioPhorum collaboration, a team of SMEs within the industry have come together to develop a best practice approach to qualifying TPS. This involves taking a risk based approach focused on specific tests required in OQ and PQ, including both thermal testing requirements and mechanical testing, such as shock and vibration.
Harmonization across the industry would lead to significant benefits for both bio-pharma manufacturers and equipment vendors. This would include; reduced time to perform transport qualifications, reduction in the resource required and repeated work and a reduced number of required shipping solutions. This would also lead to significant financial savings.
On a fundamental level, being able to collectively agree on one standard of performing transport qualifications will support drug manufacturers’ key aim – patient safety.
Key benefits include; reduced time and resources needed for transport qualification and a reduction in the number of required shipping solutions
It is imperative that the entire industry, from end users to vendors to authorities, work together to achieve this. However, developing a mutually agreeable best practice to implement is not an easy task. The BioPhorum team have been looking to slowly ‘shift the bell curve’ rather than develop a ‘true north’ best practice, as determining a singular best practice would not be feasible. Doing so would present too big of a jump from the status quo for the industry to follow successfully. Over time, any best practice proposals will need to be refined with further detail given following collaboration and testing from the industry.
Recommended best practices for the industry
At the upcoming Temperature Controlled Logistics Conference in January, the BioPhorum team will be presenting our proposed best practices. In advance, we wanted to share a teaser of some of the principles the team are thinking of.
Firstly, a key fundamental to the team’s analysis is that a risk based qualification plan should be used to justify the tests you are doing. We also think the majority of testing should be done in the OQ phase, working with the equipment vendor.
The OQ can be completed by the manufacturer of the thermal protection system and accepted by the user if the qualification matches the intended use environment. The OQ should challenge the worst case conditions, such as minimum and maximum loads, duration and temperature extremes, which are representative of anticipated shipping conditions. It is vital to risk assess your process to understand all variables that may impact a shipment. In our best practices we will aim to detail requirements for thermal testing for active and passive systems and mechanical testing, developed from extensive benchmarking and comprehensive discussions with industry leaders.
By increasing testing of worst case conditions within the OQ phase, the PQ phase can become a shorter, more efficient process
Secondly, as robust testing of extremes will have happened in the OQ phase, the Performance Qualification (PQ) phase can focus on a single transport lane. The PQ offers documented verification that the TPS, package preparation and handling processes can perform effectively based on the approved procedures and specifications. As so many critical variables, such as external temperature or weather delays, are relatively fluid and largely impossible to control, it is hard to develop multiple statistically justified runs. Thus, a single, carefully chosen Transport Lane is therefore expected to be representative of a typical shipment and sufficient to meet PQ expectations. One of the key proposed best practices from the Biophorum team is that the PQ phase should only require a single run or route, with no seasonal testing. The team firmly believe in pushing back on multiple tests in the PQ phase where possible, instead using a risk based approach to justify testing activities.
Related: Join Biophorum at Temperature Controlled Logistics to find out their full list of best practices. Receive a 10% discount as a portal member with PharmaIQ10. Find out more here
Collaboration within the industry is key to developing a best practice that all can follow, so fundamental change can be affected.
Through the work of the BioPhorum team, a starting set of best practices have been developed. This will be presented at TCL19 where industry feedback is welcome before we publish a full paper on the best practices in Q2.
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