Patient Compliance Packaging Q&A
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Asked July 13th, 2009
It is the ultimate responsibility of the NDA/ANDA holder as they own the product. The owner of the NDA/ANDA will decide which components and materials will be selected to package their product. To demonstrate equivalency of materials when a change is desired, stability testing will always be an acceptable method for demonstrating equivalency. However, this is not always cost or time effective when equivalency can be demonstrated through science. It is very advantageous for the drug manufacturer, contract packager, and material provider to leverage their resources to build the case for equivalency. In many cases, data such as the MVTR (moisture-vapor transmission rate) provided by the material provider may be used. At other times, the contract packager may provide additional data from engineering studies, such as placing “moisture dots” within the sealed primary package to confirm moisture protection. Data from these tests can be compared with the existing specification, allowing the contractor and customer to agree the two are equivalent prior to the customer filing with FDA via an annual report or another necessary filing.



