Intelsius Qualified Partner

What's it all about?

Temperature sensitive pharmaceutical distribution is a growing market. As the importance and value of temperature sensitive pharmaceutical products increase, so does the legislation around how to safely store and distribute them. The requirement for a compliant temperature controlled distribution supply chain is on the increase.

The current status quo is no longer fit for purpose and needs to change to meet future demands. New patients and new markets can mean increasingly complex distribution challenges. Legislation changes effecting other aspects of logistics will also come into play as Governments look to implement more sustainable supply chain constraints on businesses to meet tough green targets on waste reduction and CO2 production.

The revised GDP guidelines effective as of September 2013 mean that not only 2-8°C is under the spotlight but so is 15-25°C sometimes referred to as controlled ambient. The guidelines have also put much greater emphasis on the product owner to think carefully about supplier selection for storage and distribution services.

Whilst the accountability for an effective temperature controlled distribution process is that of the product manufacturer, the responsibility must be a shared objective of the partners involved in the process from end to end

What is IQP

Thermal performance of temperature controlled packaging to recognised Industry standards is essential however what has sometimes been overlooked is the robustness of the quality system and process to support effective use of high performance temperature controlled packaging.

IQP is a quality management system that will enable you use and even reuse the ORCA with assurance. IQP enables you to continually monitor, manage and measure the performance of the ORCA whether you are the shipper or the Logistics Service Provider (LSP) IQP outlines ways to achieve, as well as benchmark, consistent performance and service of your ORCA asset.
Specialist couriers, Integrators and logistics service providers will vary in terms of their performance and service levels. IQP provides for the first time those service providers the ability to put in place consistent processes produced & owned by the packaging OEM that enable them to meet their quality objectives – i.e. what your customer wants and needs.

IQP certification helps to provide confidence that product is being transported in a fully compliant process. The Annual ORCA Maintenance Service demonstrates that the asset is still performing to a level consistent with the original qualification documentation, providing continued peace of mind.

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