Industry News: Page 300
The headline is not misleading. Easy-to-remove tamper-evident induction inner seals are available that are recognized as tamper evident by the Food and Drug Administration.
In the retail market, over-the-counter vitamin, mineral, and health supplement manufacturers have used them for some time. Consumers are happy because they're receiving the tamper protection they need without the hassle of struggling to gain access to the product.
When the consumer pulls the tab on the seal, only the aluminum foil peels off, but it peels off easily. An easy-to-puncture thin paper membrane remains on the mouth of the container. Even seniors with arthritis can access the product. When the paper membrane is removed it leaves a visible residue on the lip of the container, providing tamper evidence. Among the companies using the peelable, tamper-evident seal commercially are Herbalife, Leiner Health, Muscle Tech, Nature's Way, Perrigo Co., Pharma Vita, Twin Labs, and some Wal-Mart "Equate Brand" products. October 10, 2005
When a medical device, drug, or biological product or package poses a public health risk, either to humans or animals, a recall must occur. The determination of the risk and the initiation of a recall can be by a manufacturer, at the request of the Food and Drug Administration (FDA), or by the FDA order under statutory authority.
In order to be prepared in the event of a recall, here are three steps recommended by the FDA:
1) A strategy should be in place to define the initiation and execution of a recall. A few items that ought to be included in the strategy are details on the notification of the FDA District Recall Coordinator, the depth of recall, and if public warnings are necessary.
2) The identification of the medical product(s) by lot number. While carrying out a recall, the ease of product identification can make an effective recall possible.
3) The initiation and maintenance of records for determining the location of distributed product to be recalled. September 10, 2005
"The recent recall of the popular drug Vioxx is an example of how a company can respond to crises in an organized and responsible fashion," says Rogelio Rodriguez, director of Engineering and Science Programs for the University of California-Irvine Extension. "Now, more than ever, companies are realizing the value of having a long-term crisis management plan in place."
Does packaging fit into that plan? Yes, says Rodriguez, recollecting the Tylenol poisoning of the 1980s. "How you package, label, and comply with the Food and Drug Administration's regulations," he lists as examples.
Recent regulatory and marketing changes in the life sciences industry prompted the UC-Irvine Extension to begin a two-day class called Medical Product Crisis Management, aimed at providing professionals in the medical industry with guidelines on how to develop an effective crisis management plan. The first course was held in late August. Rodriguez expects the class to be offered twice a year; the next time in January. Medical Product Crisis Management is an elective course that's part of the Extension's Medical Product Development Certificate Program. September 10, 2005
