Aesica Pharmaceuticals and QAD Collaborate to Meet China's New Serialization Requirements

Aesica Pharmaceuticals S.r.l, the Italian division of contract development and manufacturing organization Aesica, is launching an integrated serialization system from QAD for two pharmaceutical products for the Chinese market. The project at Aesica's site in Pianezza reportedly complied with new requirements from China’s Food and Drug Administration (CFDA) that cut the serialization implementation deadline to just three months from its original 12 month timeline, the CDMO reported in a press release.

Packaging Questions Already Being Raised During Preparations for DSCSA

As FDA works on developing standards for the interoperable exchange of tracing information for finished human prescription drugs, questions about packaging are already being raised. To prepare for implementation of the Drug Supply Chain Security Act, the agency held a public workshop in May during which it discussed with stakeholders the exchange of transaction information, transaction history, and transaction statements each time drugs are transferred.

Key International Offering Anticounterfeiting Technology

As the U.S. representative for Tri-Star Technologies and CertiRx, Key International is offering their technologies for detecting counterfeit pharmaceuticals, medical devices, and more. Tri-Star Technologies provides a cold laser marking system that can mark individual tablets, capsules, soft gels, or other pharmaceutical products. The indelible mark reportedly does not adversely affect the product. Patients can then obtain information about the marked individual tablets or capsules by using the CertiRx app with a cell phone by taking a picture of the dosage form.

Aesica Serializing Two Allergy Products for China

Global pharmaceutical contract developer and manufacturer Aesica reports that it has introduced serialization services and begun commercial production of two anti-allergy product lines for the Chinese market at its Pianezza site, Italy, for a global, multinational client. The implementation took under six months to complete, with the first production of serialization batches just commenced, the company reports.

Supporting Pharma During Serialization

The Drug Quality and Security Act (DQSA) of 2013 may have reset the clock for pharmaceutical track and trace and serialization, but there’s little reason for manufacturers to pause. Despite the progress made by industry pioneers and pilot programs, there are still “tremendous unmet needs,” observes Tim Marsh.

Bar Coding: Moving toward a "Batch of One"

Regardless of the regions in which your company markets pharmaceuticals, you are probably preparing for changes in product identification. A new U.S. federal law has preempted California’s electronic pedigree requirement, giving companies more time to implement new identification approaches for that market, but other requirements around the world are phasing in. And given the globalization of the pharmaceutical supply chain, drug manufacturers undoubtedly are looking beyond individual markets and searching for strategies to maximize technology investments.

Prepare for Serialization, Track & Trace while at Pharmapack Europe

“Introduction of counterfeit products in the normal international supply chain poses particular issues for pharmaceutical companies, both from direct risk to their customers and to their own reputation within what is a highly competitive industry,” cautions Charles A. Smith, senior systems consultant at Horizon. “There is a direct cost of product recall, where positive identification of counterfeits can be difficult, without the identification and data handling capabilities provided by serialization.”

Senate, Congress Pass National Drug Traceability Legislation

The US Senate by voice vote today passed the Drug Quality and Security Act/H.R. 3204, pharmaceutical traceability legislation that establishes a national requirement for tracing of pharmaceuticals through the supply chain.

Optel Vision and Tracelink Partner For Track and Trace Solution

Optel Vision has enhanced its full-service approach for pharmaceutical companies developing track and trace capability with a partnership with traceability platform provider TraceLink, Inc.

Optel Vision and NJM Packaging Tackle Track and Trace at Pack Expo

Experts from Optel Vision and NJM Packaging spoke about preparing packaging lines for item-level serialization during an hour-long conference at Pack Expo Las Vegas on September 24. Jean-Pierre Allard from Optel Vision and Dan Lapierre from NJM Packaging discussed packaging line integration challenges and possible solutions.

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