Supply chain consortium Rx-360 has issued a draft of points for drugmakers to consider in selecting tamper-evident devices for use with raw materials. The organization says the draft aims to improve the security of raw materials by enhancing security of one of the supply chain layers required.
First among the points is a distinct design for the tamper-evident device, seal or indicator. Examples include break-away caps, tear away lids and customized seals. Second, the device should carry unique identifying characteristics, like a company logo, name or trademark. Identifying characteristics should make it easy to see that the device is genuine. They should be difficult to counterfeit and available only through authorized and secure supply chains.
The remaining points are that tamper-evident devices should be single-use objects; they should be strong enough to withstand the rigors of supply chain movement; and they should be traceable.
Rx-360 notes there is no device or method that will thwart the truly determined from compromising or copying a tamper-evident device. But the use of a well-designed device increases the strength of the security measure.
- here's the draft document