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USP Draft Chapter on Visual Inspection of Injections

In February, USP published a draft general chapter, <1790>, on Visual Inspection of Injections. This chapter expands on methods and concepts in chapter <790> on Visible Particulates in Injections. USP’s focus on its visual inspection coverage parallels the high number of recalls industry is experiencing due to particulates in sterile products.

Ph. Eur. Establishes General Methods Working Party

In late February, the European Pharmacopeia (Ph. Eur.) designated a new working party to be in charge of general methods. The group will track new trends and technologies and report on them. These reports will be used to help decide when existing texts and monographs need revision.

Chinese Pharmacopoeia Opens Lab to Build Compendium

A joint lab was opened by The Chinese Pharmacopoeia Commission and Waters in late January. The lab seeks to produce an official compendium covering both western and traditional Chinese medicines.

USP Elemental Impurities Timeline

In mid-January, USP announced January 1, 2018 as the date of applicability for its chapters <232> and <2332> on elemental impurities. The new date is in alignment with the implementation date for ICH’s elemental impurities guideline Q3D. [Implementation of ICH Q3D is addressed in IPQ October 23 2014.]

USP and Russia to Develop Quality Standards

In mid-December, USP held discussions with experts from the Russian Federation on collaborating on the development of drug quality standards. A press release from USP discusses how the International Training Program (ITP) is being utilized to create more quality regulatory personnel for Russia’s Federal Service on Surveillance in Healthcare.

Pharmacopeial Discussion Group Meeting in Strasbourg

The Pharmacopoeial Discussion Group (PDG) – comprised of the European Pharmacopoeia (EP), Japanese Pharmacopoeia (JP), and United States Pharmacopeia (USP) – met in mid-November to work towards further harmonization. The groups discussed the implementation of ICH Q3D as well as future actions the group may take.

Revised USP Chapters on Plastic Packaging

Issued in USP Pharmacopeial Forum 39(5) are new chapters and subchapters relating to the use of plastic packaging systems. New versions of chapter <661> and subchapters <661.1> and <661.2> discuss the selection of safe plastics with regard to extractables, leachables, and stability.

USP and ChP Host International Forum on Strengthening Cooperation and Recognition of Pharmaceutical Standards

In mid-November in Chengdu, China, USP and ChP hosted the International Forum on Strengthening Cooperation and Recognition of Pharmaceutical Standards. The forum included regulators from many other countries and focused on international coordination and mutual recognition of pharmaceutical standards in areas such as chemical medicine, biologics, traditional Chinese medicine, pharmaceutical excipients, and packaging materials.

USP Compounding Compendium

USP released a new publication in mid-November designed to provide easy access to its quality-related standards for compounded medicines. The “USP Compounding Compendium” features more than 40 supporting general chapters and more than 170 compounding preparation monographs. The compendium will be updated with the release of new USP-NF editions and supplements.

ICH Q3D Could Provide Model for More Inclusive ICH Process; Focus Continues on Q3D Implementation Challenges, Including Risk Assessments

The development and implementation of the ICH Q3D guideline on elemental impurities could provide a model for a more inclusive ICH process....
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