GS1 US, the four types of events to be aware of
when monitoring the movements and whereabouts
of products in the supply chain are:
1. What products are impacted?
2. When did this time-stamped event occur?
3. Where was the product? Where is it now?
4. Why was this observed, which process step?
“For the most part, the FDA is going to allow
the industry to develop the procedures, processes,
and activities to meet the requirements that were
defined in the act that became law in 2013 [the
DSCSA],” explained Sturtevant. “They aren’t going
to dictate the means to the end. They’ve defined
the end, and now it’s the responsibility of the
trading partners to develop how they’re going to
meet those requirements.”
But how do we define the means to the end?
Well, let’s start by laying down the building blocks
to that end.
The Three Keystones of Traceability
“There’s three underpinnings, which are
implemented in various ways, in various forms in
the U.S. and in other countries,” said Daleiden.
The first part is serialization—establishing
unique identity at a certain level of granularity in
better designs, faster.
Tablet Coating: Improve inter-particle
coating uniformity by using optimal
spraying equipment settings.