We apologize your item could not be found. Not all items are listed on our website. Please contact your account manager for details regarding your searched item.
Material number (eg: xxxxxxxxxxx) no space or hyphen needed.
No Results Found
West has announced a new online resource center to assist pharmaceutical and biopharmaceutical manufacturers as they prepare for the industry’s revised standard regarding labeling 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 November 1, 2010).
The revised USP General Chapter <1> Injections standard will go into effect on December 1, 2013. The standard applies to multiple packaging, storage and labeling requirements, as well as procedures and methods that provide specifications for individual drug products or substances. The revision will limit printing 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 key information, considerations and regulatory assistance to prepare for implementation of the revised standard.
“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 is working side-by-side with customers to provide high-quality insight and guidance through the transition and ensure uninterrupted product supply.”
On December 1, 2013, the United States Pharmacopeia (USP) General Chapter <1> Injections<em>, </em>Labeling on Ferrules and Cap Overseals (USP 34-NF 29 November 1, 2010) revised standard will become effective. The revised chapter affects all injectable drug products, human and veterinary, intended for sale in the United States.
On December 1, 2013, revisions to USP Ch. <1> Injections, Labeling on Ferrules and Cap Overseals will go into effect for all drug products sold in the United States, including veterinary products. Now is the time to ensure that your product packaging is compliant.
The revision to the United States Pharmacopeia (USP) General Chapter <1> Injections, Labeling on Ferrules and Cap Overseals standard becomes official on December 1, 2013. The revision will limit printing to <span style="text-decoration: underline;">only</span> cautionary statements on the top surface of the ferrule or cap overseal of a vial containing an injectable drug product sold within the United States. Seals with the embossed “Flip-Off” or printed with other non-cautionary labeling will not be compliant with this new standard.
On January 1, 2018, new USP standards became mandatory for measuring elemental impurities in pharmaceuticals and their ingredients – aligning with ICH Q3D, which provides limits for the amount of elemental impurities in drug products. New USP General Chapters, USP <232> (<em>Elemental Impurities – Limits</em>) and USP <233> (<em>Elemental Impurities – Procedures</em>) have replaced USP <231> (<em>Heavy Metals</em>). USP <231>, which historically was used to test for heavy metals in drug products as well as packaging components, has been withdrawn. However, the heavy metals testing in USP <381> (<em>Elastomeric Closure for Injections</em>), which is used for testing of elastomeric closures, still references USP <231>.
The American Association of Pharmaceutical Scientists (AAPS) held its annual meeting and exposition in Denver, CO from November 13-16. This meeting continues to be a major event in the calendar of pharmaceutical scientists in academia, the industry, government and research institutions who come to participate in training events and focus group meetings, hear subject matter expert presentations, and network with customers and suppliers at the 3-day exposition.
English
Chinese
