The United States Pharmacopeia (USP) New Chapter on the Storage and Distribution of Investigational Drug Product (IDP)
The USP has created a new chapter to address the storage and distribution of IDP. This is significant because it is the first time in the long history of USP standards that this topic has been addressed. But in order to fully understand the depth and scope of this new chapter, the history of its inception must be covered first.
The Packaging and Distribution Expert Committee is charged with the maintenance, review and updating of the appropriate chapters covering the storage and distribution of drug products and starting materials. Two chapters that were already official were undergoing review, <1079> Good Storage and Distribution Practices for Drug Products1 and <1197> Good Distribution Practices for Pharmaceutical Excipients.2 While this review was occurring, it was noted that although both chapters were meant to cover Good Distribution Practice (GDP), there were areas of overlap as well as areas covered that were specific to the particular chapter and not covered in the other. This bit of insight led the USP to take a step back and analyze these two chapters at the USP Supply Chain Workshop in 2012. Through this process the USP came to the conclusion that the approach to GDP has been piecemeal. For instance, while GDP is an overarching subject, individual components (e.g. excipients and drug products) were being addressed in separate chapters. Therefore, individual topics, such as storage and shipping, supply chain integrity, and importation/exportation issues were repeated in separate chapters with respect to the individual topics.
Source: Pharmaceutical Outsourcing
