West
West has announced a new online resource centre to assist pharmaceutical and biopharmaceutical manufacturers as they prepare for the industry’s revised standard regarding labelling for cap overseals and ferrules on injection vials — United States Pharmacopeia (USP) General Chapter <1> Injections, Labeling on Ferrules and Cap Overseals (USP 34-NF 29, 1 November 2010).
The revised USP General Chapter <1> Injections standard will go into effect on 1 December 2013. The standard applies to multiple packaging, storage and labelling requirements as well as procedures and methods that provide specifications for individual drug products or substances. Beginning 1 December, printing will be limited to cautionary statements on the top surface of the ferrule or cap overseal of a vial containing an injectable drug product. A cautionary statement is defined as one intended to prevent an imminent, life-threatening situation if the injectable drug is used inappropriately.
The West USP General Chapter <1> Online Resource Center is designed to provide drug manufacturers with information to prepare for implementation of the revised standard. The website includes an informational videoand links to USP resources.
“The revised standard represents a fundamental shift in the pharmaceutical and biopharmaceutical industry and drug manufacturers need to begin preparing now for implementation,” said Carol Mooney, Global Market Segment Director, West. “West is working side-by-side with customers through the transition to help ensure uninterrupted product supply.”
The West Online Resource Center is available at: bitly.com/USP1OnlineResourceCentre.
West Pharmaceutical Services, Inc., +1 610 594 2900, west.pharmaceutical.services@westpharma.com, www.westpharma.com.