How Long Until You Are Fully Serialized?

This week, IQPC released the final report of a very interesting survey they conducted in April through June this year.  The results are fresh and they paint a picture with good news, and not so good news about the readiness of pharmaceutical manufacturers facing serialization deadlines in the United States, the European Union and elsewhere.  The survey focused on serialization planning, implementation progress, traceability in operation and benefits beyond compliance.  You can download the full report here, but let’s take a look at the responses to just one of the questions they asked. Continue reading How Long Until You Are Fully Serialized?

DSCSA Verification and Suspect Product

Last week I wrote about the debate over the number of possible responses to verification requests in any potential solution the industry might adopt to meet the Drug Supply Chain Security Act (DSCSA) (see “DSCSA Red Light Green Light: Verification Responses”).  Today I want to take a closer look at a related issue:  the relationship between verification and suspect product.  Most specifically, does a failed verification automatically force a product into the suspect product category?  The answer might surprise you. Continue reading DSCSA Verification and Suspect Product

DSCSA Red Light Green Light: Verification Responses

Yellow stoplight
Even a stoplight has three lights

There is an important debate going on over the last 9 months regarding exactly how many different answers companies should prepare to provide in response to a DSCSA verification request.  Some say two:  “Red light” or “Green light”.  And others say three:  “Yes”, “No”, or “It’s Complicated”.  This might seem like a minor question, but people on each side are surprisingly passionate about their positions.  Let me explain. Continue reading DSCSA Red Light Green Light: Verification Responses