Per cGMP best practices and other industry standards, shipping container systems (“shippers”) must be fully qualified to demonstrate the ability to maintain appropriate storage conditions for temperature-sensitive pharmaceutical products during transport, and can demonstrate that the system can survive transport and handling whilst protecting the physical integrity of the product.
The qualification has three sequential steps: design qualification (DQ), operational qualification (OQ), and performance qualification (PQ). The DQ is not required if the manufacturer can demonstrate that the product has already passed an appropriate conformity assessment, or if the shipper has been independently pre-qualified per end user requirements. Also, if the system manufacturer can supply a satisfactory OQ report that meets the end user’s specifications request, the OQ may not be performed.
The PQ, however, is mandatory in most cases and must be conducted as a field test. A performance qualification protocol must be developed to document the process and define acceptance criteria that are similar to the criterion defined in the DQ and OQ protocols. The PQ requires a minimum of three runs for both the minimum and maximum product load for each of the hottest and coldest months of the year (summer and winter).
Masy BioServices can work with you to create a custom protocol procedure or follow your existing protocol to complete your shipper DQ, OQ, and PQ as required. We provide trained and experienced validation personnel and the required equipment to provide you with a full qualification package.
Contact Masy BioServices today for your shipper qualification needs.