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Type: News

Section: Industry News > Regulatory

Regulatory

Security label substrate

ArjoWiggins offers synthetic security label substrate for the healthcare packaging industry.

April 10, 2006

Regulatory

Validation continues to challenge packagers

Respondents address the issue in an exclusive Packworld.com survey. A Packworld.com survey completed in January asked respondents to identify the most important among five healthcare packaging-related issues for their company in the next year or two; 37% of packagers cited validation. Counterfeiting and good manufacturing practices (GMPs) each received 17% of the "vote," followed by FDA regulations at 12%, and outsourcing at 7%. Among the 10% who selected "other," the most frequently mentioned topics were package innovation, and offshore regulations. Here's a sampling of some of the responses regarding validation:

April 10, 2006

Regulatory

RFID: FDA unhappy with progress in pharma

Might the FDA set a mandatory RFID standard? Comments from a February 8 and 9 meeting make it likely. On February 8 and 9, the Food and Drug Administration sent a signal on RFID to the pharmaceutical industry, which companies clearly received. "I am disappointed at the apparent slowdown in RFID implementation," stated acting FDA commissioner Andrew von Eschenbach at a meeting of the FDA Counterfeit Drug Task Force in Bethesda, MD. Eschenbach asked the task force to figure out what was slowing down drug companies on RFID and to make recommendations to him by May. Based on the comments of the members of the task force, who are all FDA legal, regulatory, and enforcement officials, it seems very likely the FDA will develop a mandatory standard requiring pharmaceutical companies to adopt RFID tagging in a phased manner, with the highest-risk drugs going first.

March 10, 2006

Labeling/Printing

Security labeling

Acucote Inc.

March 10, 2006

Regulatory

FDA audits: Maintaining a constant state of readiness

The Food and Drug Administration audits Anderson Packaging's operations annually. So do the contract packager's customers. Facing these annual audits of its facilities and procedures, Anderson Packaging follows the following quality-control steps to win auditors' approval: • Sophisticated vision systems check pills, capsules, and liquids to ensure that product units are not broken and that they are placed properly in each package. Such equipment is extensively validated prior to start-up and continuously challenged to maintain its integrity. Each package component is barcode-scanned to confirm accuracy. • A full-time staff trains new workers in pharma product and packaging basics, and then develops their skills to more advanced levels. Training is documented and made available to external auditors. • Anderson has strict requirements on the inspection of packaging components as they arrive at its facilities. Typically on the inspector's checklist: package integrity, print quality and correctness, and chemical properties. • Quality-control inspectors check the quality of finished packages, both in-process and after a packaging run.

March 10, 2006

Regulatory

European RFID requirements present challenges

Third in a series of reports from last November's RFID Healthcare Industry Adoption Summit in Arlington, VA.

February 10, 2006

Regulatory

Facility and equipment validation services

February 10, 2006

Supply Chain

Object marking and sensing technology

Dramatic changes in the economic landscape over the past 18 months have customers relying on distributors to an even greater extent, frequently viewing them as an extension of their package-sourcing department.

February 10, 2006

Regulatory

Item-level e-Pedigree implementation

Pfizer is one of five pharmaceutical pilot implementations of an item-level serialized RFID solution with "parent-child" association software. How can pharmaceutical companies protect their drugs and consumers against the growing blight of counterfeiting and product diversion? One option is the Total Integrated Packaging Solution (TIPS). TIPS works in conjunction with serialized item-level RFID to protect products throughout the supply chain via a parent-child approach to the electronic-pedigree chain of custody.

February 10, 2006

Regulatory

Drug counterfeiting: The battle rages on

As someone who takes prescription drugs on an ongoing basis, I found Katherine Eban's book, Dangerous Doses—How Counterfeiters Are Contaminating America's Drug Supply, to be an eye-opener.

February 10, 2006

Robotics/Automation

Validation: Drug makers take an enlightened view

Conversations we've had lately with packaged goods manufacturers suggest that some of them are beginning to soften their insistence on a preferred packaging machinery controls architecture that they have established for themselves. Why? Because when a builder of packaging equipment settles on a controls package, it can build machinery faster and deliver it at a more attractive price. If the machine builder has to replace the controls components with what its customer wants, it can't build, deliver, or maintain equipment as efficiently.

February 10, 2006

Regulatory

Drug companies on different RFID frequencies

Second in a series of reports from last November's RFID Healthcare Industry Adoption Summit in Arlington, VA. Bruce Cohen, director of packaging technology for GlaxoSmithKline (GSK), said that his company was ready to start tagging one of its drugs, which he declined to identify. Cohen made it clear that GSK was honoring its commitment to the Food and Drug Administration, which in February 2004 agreed to give pharmaceutical manufacturers some breathing room to implement RFID tagging voluntarily. At that time GSK pledged that it would tag at least one product within 12 to 18 months. But Randall Lutter, associate commissioner of the FDA, told attendees at the conference sponsored by the National Assn. of Chain Drug Stores and the Healthcare Distribution Management Assn., "From our vantage point today, it appears a voluntary approach may not be enough. At this point we have become concerned about the slow or inadequate progress [being made in] implementing an electronic pedigree." Lutter's impatience aside, the conference featured evidence that the pharmaceutical industry is not exactly mired in RFID mud. Even generic drug manufacturers, who have been lagging behind on RFID for the most part, are expanding their implementations.

January 10, 2006

Regulatory

Steps to a successful RFID deployment

After a successful pilot program, your RFID system is ready for production, the final deployment step.

January 10, 2006

Regulatory

Talking out load about validation issues

Packaging pros candidy discuss the ever-challenging issue of validation.

January 10, 2006

Regulatory

Brand authentication

January 10, 2006

Regulatory

Pondering material and machinery advances

"Advances in online package inspection and integrity testing are exciting," exclaims Dana M. Guazzo, Ph.D., president of consulting firm RxPax LLC. "These include high-speed, noncontact ultrasound inspection technologies, light reflection technologies, and gas tracer techniques." David Rudd, a senior engineering specialist with Cardinal Health, doesn't "anticipate any breathtaking advances. I do expect continual incremental improvements facilitated by increased application of servo motors, improved control software, and a drive to reduce costs. I'd like to see lower-cost machines that will allow users to buy more machines for increased scheduling flexibility." On the materials side, Rudd says, "I expect that the development and acceptance of a better microbial barrier test will allow medical device manufacturers to make more informed decisions about materials used for sterilization vents."

January 10, 2006

Regulatory

Pfizer RFID tags its lots of Viagra

First in a series of reports from the RFID Healthcare Industry Adoption Summit in Arlington, VA.

December 10, 2005

Regulatory

Steps to Successful RFID Implementation

Last month, RFID authority Patrick J. Sweeney pointed out that the first step is creating the metrics to measure the change created by RFID. Here, he discusses creating an RFID team and planning your solution.

December 10, 2005

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