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Newly revised Chapter unites temperature control, security and import/export guidance under an overall quality management system
Two years ago, the US Pharmacopeia (Bethesda, MD) made a bid to write new guidance for manufacturers and others involved in healthcare products distribution, with a proposed Chapter <1083>, Good Distribution Practices. Following involved reviews of that draft, it was dropped, and now its replacement, also called Chap <1083>, has been published in the Pharmacopeial Forum, and comments are being solicited for its review and acceptance. Additionally, next week (May 6), Mary Foster, PhD, chair of the USP Expert Committee for Packaging, Storage and Distribution, will conduct a webinar explaining the scope of the proposed guidance.
Relative to the previous effort, the new <1083> is subsuming two existing USP Chapters, <1079> Good Storage and Distribution Practices and <1197> Good Storage and Distribution Practices for Bulk Pharmaceutical Excipients. It also extends its scope to essentially all healthcare products—pharmaceuticals, medical devices, bulk ingredients and the like. And it is divided into four distinct sections:
• Quality Management System <1083.1>
• Environmental Conditions (Supply Chain Temperature) Management <1083.2>
• Good Importation and Exportation Practices <1083.3>
• Supply Chain Integrity and Security <1083.4>
Somewhat surprisingly, although the previous version had extensive commentary on pharmaceutical “pedigree” (i.e., a track-and-trace system for monitoring product movements), the new version has little to no discussion of the topic—even though federal legislation is now in place for that process in the US.
USP has an indefinite relationship to actual law or FDA regulation. The organization is federally chartered, and FDA depends on it for specific rules and definitions on the composition of a variety of healthcare products (these are generally known as USP Monographs). The USP “chapters” are specifically written as guidance, not regulation. Nevertheless, those guidances often become the basis for business practices and policies between manufacturers and their service providers. It’s also worth noting that the new USP chapter borrows extensively from the principles embodied in the Good Distribution Practices rules in the European Union, which are now affecting numerous aspects of pharma distribution there.
The draft documents (as well as earlier versions) are accessible at a USP website, www.uspf.org (registration required; once registered, look for Vol. 40 and then “PF40”). Comments can be submitted until May 31.