Points to Consider in Filing Data for Shipment of Temperature Controlled Drug Substances/Products
Twenty years ago, the risk to drug substance/product quality due to temperature excursions during shipping was not generally appreciated. A series of studies led to several papers in USP PF which documented some of the risks1-4. In response, increasing regulatory requirements related to supply chain temperature controls have led to inconsistent approaches to what types of data are required and, once data is developed, which sections within the filing (eCTD) to submit these types of data.
This paper will list types of data that is now being requested to show supply chain temperature controls and recommend areas within the filing to submit these similar data. However, the location within the filing is a recommendation, realizing that data generated for a specific reason may be suited to another section better than the example recommendations. It is paramount that the data filer knows what the data will be used for – to better understand why one section is better than another. It is also recommended that same data sets not be filed in multiple locations – but that they be cross-referenced.
Source: Pharmaceutical Outsourcing