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USP updates several chapters in the U.S. Pharmacopeia-National Formulary (USP–NF)

The United States Pharmacopeial Convention (USP) is updating several chapters related to pharmaceutical packaging, a few of which we cover here.

The revision of USP Chapter <661> Containers—Plastics has been "a labor of love," says Desmond Hunt, PhD, Senior Scientific Liaison for USP.  A revision was needed, says Hunt, "because the chapter was outdated and did not generate data that helped end-users determine the suitability of a packaging material." Now titled Plastic Packaging Systems and Their Materials of Construction, <661> currently includes two subchapters <661.1> Plastic Materials of Construction and <661.2> Plastic Packaging Systems for Pharmaceuticals. The chapters were first published in PF 39(5) September/October 2013, and after a comment period and revision process, they were republished in PF 40(5) in September/October 2014. Click here for a link to the stimuli article

"It’s a paradigm shift," Hunt says. "In December, of 2013, we had a workshop to discuss the chapters and it was well attended, due to industry’s interest in the topic and the potential changes." 

Calling the revision "industry driven," Hunt says that "PQRI’s best recommendation practices are built into these chapters. Its recommendations set us on this path."

The principle behind the revision is the idea of using "well-characterized materials," says Hunt. "We want to know that a material of construction meets certain requirements, which is the first step in determining whether that material is suitable for a final packaging system. You should have a good understanding of the materials of construction, as well as potential extractables."

And in keeping with Quality by Design principles, the approach should enable users "to start with a good material of construction and end with a good packaging system," he says.

The new chapters require more testing, says Hunt, "but at the end of the day, you will have a better understand of your packaging system." 

Other subchapters are planned for the future: <661.3> Plastic Systems Used for Manufacturing Pharmaceutical Products and <661.4> Plastic Medical Devices Used to Deliver or Administer Pharmaceutical Products.

USP has not received any comments, and they can be submitted through November 30. To share comments on USP's chapters, send emails directly to Dr. Desmond Hunt at [email protected].

Other changes from USP include the revision of Chapter <659> Packaging and Storage Requirements, which is underway and planned for publication in PF 41(4) in July 2015. The chapter was initially developed to place all Compendial packaging and storage definition in one place; the chapter became official in 2011.

Before 2011, "most packaging definitions were in General Notices and needed updating,"  says Hunt. "We waited for industry to digest the 2011 revision, which was just moving the definitions with some minor editing. We expect some significant changes, additions, and edits to be appropriate for industry."

USP works closely with FDA in the development and revision of chapters, with a liaison from FDA sitting on the Expert Panels and Expert Committee. 

Pharmaceutical packaging engineers should "really be aware of these definitions and how they apply to other chapters," says Hunt. The chapter also consolidates all definitions for packages, storage, and distribution. "We also expect it will lead to revisions in other chapters," he says. 

USP Chapter <381> Elastomeric Closures for Injections is also up for revision. "We’ve just formed an Expert Panel, says Hunt; and they will be working towards modernizing the chapter," he adds.

USP is also looking to modernize Chapter <660> Containers—Glass, which covers glass durability, says Hunt.

By Daphne Allen, Editor
Pharmaceutical & Medical Packaging News

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