[Whitepaper by Marken]: Shipping Qualification: What is it and Why is it Necessary?

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Shipping Qualification: What is it and Why is it Necessary?

Shipping qualification is a process which demonstrates that a product will be both physically and thermally protected throughout the entire shipping process. It requires documented testing for each segment of a shipment including, transfer of the product from controlled temperature storage, shipping container packout, transport of the product and delivery of the shipment.

A successful shipping qualification process identifies and addresses potential risks to pharmaceutical product during transportation. It results in a reduction of product loss and supply delays with more predictable deliveries, saving companies time and money.

What is it?
A shipping qualification process and final report is designed for a company’s unique shipment and acceptable criteria must be established for each part of the process. The acceptance criteria should allow for a specific range of temperatures across a predetermined transport route, with slight variances in payload size and packaging configuration of shipments. Shipping qualification of a temperature controlled pharmaceutical shipment should consider the following factors:

Temperature Range
An acceptable temperature range should be determined based on the stability data of the substance being shipped. Stability testing takes place outside the qualification process. The data produced from the testing confirms the duration and temperature range the product can withstand and still maintain efficacy.

The selection of product containers should be evaluated early in the development process. In selecting the best primary container, leachable/extractable testing, container closure integrity and functionality testing of the container must be performed. This testing must consider all expected thermal and physical conditions. Primary product containers should also be evaluated for their ability to tolerate shipping conditions like shock, vibration, compression, light and pressure. Conducting these tests early in the process can avoid costly changes due to failures, discovered later during shipments.

A validated shipping container should be chosen to support the acceptable temperature range and estimated transit time to ensure the product maintains integrity throughout a shipment. The size of the shipper selected should be based on the dimensions of the batch it will contain. Consideration should also be given to the packaging cost, reusability, thermal and physical protective ability.

Load Configuration

Load configurations should be qualified to determine the acceptable minimum and maximum loads based on mass. Additionally, thermal and physical protection of the product containers must be demonstrated. Payload is evaluated using a 3D distribution of calibrated temperature monitors and is then subject to extreme temperatures during exaggerated durations, along with physical stress such as shock, vibration, compression and pressure. Data gathered in this testing is used to determine potential risk and remediation necessary for product containers; fill volumes; payload configurations; product and shipping material conditioning temperatures and durations; and positioning of temperature monitors.

Transport Routes
A transport route from origin to destination should be selected by evaluating the probable cost, transit time, temperature control and reliability of each available mode of transportation. Consideration should also be given to each node that would be utilized during the shipment with regard to customs clearance times, proximity to chosen modes and seasonal minimum and maximum average and extreme temperatures at each location.

There are three main elements to the qualification process. Each element must be carefully documented and reported in a qualification protocol. These elements are:

Design Qualification / Investigational Study (DQ/IS) – This is carried out when there is no existing in-house knowledge, or data for a similar qualification.

Operational Qualification (OQ) testing utilizes an approved protocol and demonstrates the ability of the packaging solution and configuration to withstand temperature extremes physical protection (ISTA testing).

Performance Qualification (PQ) testing confirms the developed process is effective, robust and repeatable. Typically, three shipments are conducted using an approved protocol to test the actual lane and processes.

Why is it Necessary?
In most countries, Good Distribution Practices (GDP) for pharmaceuticals requires that thermal control during transportation be demonstrated. Additionally, the potential cost of a failed shipment, whether due to temperature excursion or physical damage, can result in significant impact to patients, financial loss, manufacturing delays and time consuming, costly product retesting. In many cases, the loss of a single shipment may be more than the expense for conducting qualification.

Many pharmaceutical companies do not have the testing resources and lack trained personnel with the specific knowledge and regulatory expertise needed to perform a complete shipping qualification. Companies that cannot carry out an in-house shipping qualification may outsource it to a supply chain provider who can.

Marken offers shipping qualification tailored specifically to a company’s product(s). We can provide testing or advise third party test labs for each part of the qualification process to include primary container and shipper selection; container closure and leachables/extractables testing; submission readiness and preparation; creation of design qualification, operation qualification and performance qualification documentation; and comprehensive lane development.

Marken clearly outlines the roles and responsibilities related to a shipment and trains assigned personnel for proper execution. We offer detailed instruction on when and how to order packaging materials; accurately package a shipment; coordinate with a courier; complete necessary paperwork; obtain licenses and permits; and create contingency plans for natural disasters or other unexpected events.

Marken has been providing global logistics solutions for 35 years and is 100% dedicated to life sciences. Our team of experts has extensive practical experience performing all aspects of shipping qualification, and assigns a dedicated, fully trained project management team to support each project. Marken offers complete world-wide shipping qualification solutions.

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