3 STEPS TO DETERMINE NEED FOR PERFORMING A SHIPPING LANE QUALIFICATION

Materials moving through the Pharmaceutical Supply Chain encounter many threats which could negatively impact product integrity. In order to adequately determine the level of control required to ensure safe transport of products, one must perform various risk assessments.

Performing a risk assessment will provide visibility into the different risk factors and allow for proper resource allocation to mitigate those risks based on their potential impact. Based on the findings of these risk assessments, you can determine if the need for performing a full shipping lane qualification is recommended.

1. Perform a risk assessment on your products. Performing a risk assessment of your products will allow for the stability of the material to be evaluated. Products with little or no stability data, or data which shows a great level of impact to products when exposed to out of spec. conditions in transit, could signify the need for additional controls to be put into place. Products with relatively robust stability data may require a lower level of control to be implemented. Also to be considered is the relative value and quantity of the products being transported. Products with high value and little reserve stock may also be potential indicators of the need for a shipping lane qualification to be performed.

2. Perform a risk assessment on your shipping solution. Performing a risk assessment of your shipping solution will reveal the level of controls to be implemented in transporting your product to its final destination. Solutions with stringent testing criteria may perform more effectively, and for longer, than solutions that have not been tested as strictly. Also, looking at the level of difficulty involved in handling, and as needed, intervention may indicate the need for additional controls or qualification. Evaluating the chosen shipping solution will go a long way in determining the level of controls put into place for its transport.

3. Perform a risk assessment of your processes. Performing a risk assessment of your processes will allow you to identify gaps and areas which require more focus. These “weak spots” in the process may include segments in transport where the products are in the hands of your service providing partners. The more complicated the process and the movements through the supply chain, the more relative the shipping lane qualification becomes. Simple movements utilizing overnight shipping services, for example, may be deemed as acceptable without performing the qualification.

As we see, there are many factors which come into play when determining the need to perform a shipping lane qualification for the transport of your pharmaceutical products. A shipping lane qualification is one way to ensure that your product, within your shipping solution and using your partners and processes, will maintain its integrity through the chain and arrive as viable as when it was tendered. A shipping lane qualification can go a long way in proving that all of the components and processes will perform as expected with a high degree of certainty.

Singota Solutions is a US based CDMO in Bloomington, Indiana. Singota specializes in formulation development and aseptic fill finish for injectable projects. Once a formulation is established, Singota utilizes state of the art robotic filling technology and focuses on smaller batch size requirements. For more information, visit Singota.com to explore how Singota has established itself as a one-stop solution for all your developmental needs.

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