The Global Harmonization Task Force (GHTF) has released its proposal for a draft guidance on a Unique Device Identification (UDI) system that could be used around the world. The goal of the guidance is to provide a common global framework for identifying medical devices, which could facilitate recognizing recalled items and reporting specific devices involved in adverse events. Comments on the draft are welcomed through April 30.
In February 2011, the European Parliament adopted the “Falsified Medicines Directive.” The legislation is intended to protect EU citizens from falsified medicines, which are defined as products that “may contain ingredients in the wrong dosage or no active ingredients at all.” A distinction is made between “falsified medicines” and “counterfeit medicines,” which are defined as “medicines that do not comply with EU law on intellectual and industrial property rights, such as registered trademarks or patent rights.” According to a mem
We hear a lot these days about sunrise dates in the global GS1 System of product identification and related supply-chain standards. A sunrise date is a date in the future, agreed to and typically announced years in advance, at which point an industry or market sector is expected to be prepared to implement a specific technology.
Comments on FDA's proposed update to its Bar Code Labeling guidance regarding vaccines are in, and they all reflect the challenges inherent to any sort of change in drug product identification. Industry seems ready to move toward alternative technologies, but some end-users fear that multiple coding technologies coexisting in the supply chain could lead to chaos. Some urge FDA to standardize—even beyond vaccines—but will FDA's efforts be enough to transform healthcare practice?
In October, Joseph Ringwood, COO, Systech International, joined PMP News Editor Daphne Allen to discuss the global serialization landscape in a live Webcast. Earlier this year, Allen interviewed Ringwood along with Systech’s customers to prepare the white paper, “Establishing a State of Readiness: Mass Serialization as a Business Strategy.” Systech International has more than 150 lines serialized and is involved in 90% of all serialization deployments.
American Health Packaging launches two additional SKUs to its growing unit dose line. The launches include Tacrolimus 0.5 mg, 1 mg and 5 mg capsules and Metroprolol Succinate ER 25 mg, 50 mg, 100 mg and 200 mg tablets, which are American Health Packaging exclusives. American Health Packaging is the only bar-coded, unit-dose offering in the marketplace. Other recent launches that are not exclusive include doxycycline Hyclate 100 mg tablets and anastrazole 1 mg tablets.
Introduced more than 15 years ago to provide a convenient migration path for companies converting from the Health Industry Bar Code (HIBC) Supplier Labeling Standard to the global GS1 System of product identification and bar code marking standards, Application Identifier AI(22), “Secondary Data for Specific Health Industry Products,” is now slated for withdrawal effective January 1, 2013.
Imagine having your coding data and your power delivered by one cable. What benefits could such a system deliver to your packaging line?
Code Tech Corp. (Princeton, NJ) is introducing the first Power-over-Ethernet (PoE) self-contained HP print module, the I jet. Manufactured in Germany by Mark-o-Print GmbH and distributed in the United States by Code Tech, this new HP printer can interface with all vision systems platforms and acts as a discreet device on the line.
FDA refined its draft guidance on a serialized numerical identifier (SNI) for prescription drug packaging with the issuance of final guidance March 26. http://www.fda.gov/RegulatoryInformation/Guidances/ucm125505.htm.