Shipping Validation FDA Guidance | Is CSA applicable to Shipping Validation?

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1. Shipping Validation

Shipping Validation

It doesn’t seem that the two can be related or that CSA applies to Shipping Validation.  In actuality, CSA is not only applicable, but helpful for shipping validation efforts. Computer Software Assurance (CSA) applies to all aspects of software validation, including data software used in the shipping / secure supply chain process.

Shipping Validation and Computer System Validation (CSV) are important in ensuring the shipping pack-out, parameters, and data recording operate as intended to deliver the product or samples in useable form, per process parameters.  Just as process validation ensures the product is manufactured consistently to meet set parameters, shipping validation ensures the product or samples are delivered consistently to ensure product integrity.

While packaging engineers and process engineers consider the transit stresses, temperatures, and pack-out configurations, the IT team is reviewing the data flow and validation of the shipment data.  Shipment data is commonly transmitted through cellular data networks, stored on local memory, or uses both as part of a secure supply chain.  The shipment data is often displayed on web portal dashboards and in reports, while the raw data is stored electronically or in paper format.  Shipment data requires a data governance plan, with a strategic validation plan for GxP data and electronic records.

The data flow pathway managed by the data governance plan is critical to data management.  If a data path includes commitment of data to permanent storage media, this is an electronic record.  In some processes, due to a lack of technology or planning, the electronic record is deleted, while the printed data is maintained in offsite, secure storage.  This practice does not reflect current data and records management compliance expectations.  A printing data on paper and deleting / ignoring electronic records is a circa-2000’s data and records management practice, due to a lack of inexpensive, secure, and stable memory storage at that time.  Now, we have unlimited, secure cloud storage options for electronic records.  When considering the shipping validation, ensure the shipment data governance plan is aligned with 2020’s electronic data storage standards.

Shipping validation CSV includes standard CSV documents: URS, Validation Plan, Qualification protocol, Trace Matrix, and Validation Summary Report.  The focus is on the data flow pathway and any alarms which are set to notify supply chain and shipment recipients.  As there are frequent updates to the shipment data flow paths for temperature and condition monitors, in addition to “family” or “common equipment” validation strategies, use of a pre-approved standard protocol is recommended.  Standard protocols ensure consistency in testing every time there is a firmware, technology, or vendor change.

Additionally, the shipping validation strategy must be appropriate with the product phase, material type, and risk level.  CSA and the functional risk assessment (FRA) are critical for “focused” validation efforts.  Using a FRA for the shipment engineering and computer systems portion of the validation allows for leveraging previous testing or vendor testing. Optimally, the shipping validation CSV FRA is aligned with CSA, allowing for ease of shipping technology change validation updates.  Polarion ALM maintains the risk assessment in real time, allowing for ease of determination where changes impact the current, effective shipping validation and shipping Computer System Validation (CSV).

With regards to the shipment portion of the validation, it’s critical to document proper shipping configuration.  Receiving a cracked Styrofoam shipper with far too much dry ice spilling out of it or finding the samples placed on top, not inside, of the dry ice results from a lack of shipment pack-out details.  Highly viscous liquids may require multiple days of resting time to allow micro-bubbles to settle out.  The details are important to document, for shipment consistency.  Shipping and receiving procedures should specify all required shipment details, to ensure team members directly involved in the shipping operations are aware of the critical details for each material. Shipping is truly an interdepartmental team effort.

Finally, the number of shipments and shipping lanes are determined.  Typically, three shipments are sent on different days to ensure consistency in the transit data obtained.  The shipping lanes are typically domestic and international longest distance.  Furthermore, seasonal conditions are to be considered when planning the shipments.  A shipment across the equator challenges the shipment to both winter and summer conditions, for an efficient validation over several days.

Shipping validation is a complex procedure consisting of physical shipper qualification, shipping validation and computer system validation, all at the same time.  While the complexities of shipping validation remain, the Compliance Group team and Polarion ALM can assist your teams with determining the appropriate risk-based, phase-based shipping validation strategy.

For more information, or just to bounce some questions and get help, please contact me at info@complianceg.com.