Recently, Aphex undertook a body of work with respect to shipping validation. Once a gap assessment was performed a plan was put in place to ensure that the mode of transportation selected was commensurate with maintaining the product’s critical quality attributes.
We have found in our experience in this field that companies can completely ‘over spec’ the shipper they wish to transport the product in. Understanding a product’s CQAs, as well as understanding product stability data plays a significant role in shipper selection. Not only that, but consideration should be given to the lane that the product is shipped in, batch size, ‘hot’ and ‘cold’ seasons and climatic zones it travels in.
In this particular instance, due diligence was taken to appropriately temperature map the consignment and confirm that it was free from damage prior to and after shipment. All of this work was conducted under a process validation protocol. Calculating the number of runs to perform as part of process validation was conducted as part of an FMEA to assess the risk of shipping product in a certain lane and to derive logic behind the validation effort to be applied.