Type of Posting: General Announcement
Posting Date: 13–June–2014
Expert Committee: General Chapters—Packaging, Storage, and Distribution
USP is offering stakeholders the opportunity to provide additional feedback on five recently-proposed General Chapters related to storage and distribution.
USP proposed five new General Chapters on Good Distribution Practices (GDP) in Pharmacopeial Forum 40(2) [Mar.–Apr. 2014]:
- <1083> Good Distribution Practices
- <1083.1> Quality Management System
- <1083.2> Environmental Conditions Management
- <1083.3> Good Importation and Exportation Practices
- <1083.4> Supply Chain Integrity and Security
These General Chapters were developed based on stakeholder feedback and the review of two existing General Chapters: Good Storage and Shipping Practices <1079> and Good Distribution Practices for Bulk Pharmaceutical Excipients <1197>. These two existing General Chapters provide information related to the storage, shipment, distribution, and transportation of pharmaceutical components and products. The review showed overlapping and complementary items among these General Chapters and highlighted the need for USP to develop an overarching approach to this subject matter. With this intent established, the USP Packaging, Storage, and Distribution; Compounding; Physical Analysis; and Excipients Expert Committees proposed the above series of new General Chapters to replace the existing General Chapters <1079> and <1197>. The new General Chapters will cover the flow of pharmaceutical ingredients and products, medical devices, and dietary supplements beginning with initial procurement and continuing throughout the supply chain to delivery to the end user, highlighting best practices and principles.
The comment period for the proposed General Chapters ended on May 31, 2014. In addition to the normal commentary process, however, USP would like to further engage stakeholders (e.g., manufacturers, distributors, transportation providers, healthcare providers) to identify and discuss potential impacts of the General Chapters on the pharmaceutical industry. In order to accomplish this objective, USP welcomes interested stakeholders to contact Dr. Desmond G. Hunt, Senior Scientific Liaison (301-816-8341 or firstname.lastname@example.org) by August 31, 2014 to set up a meeting to discuss the impact of the proposed standards.