Tag Archives: randomization

PIA, POD, Randomization

DSCSA: Congress Should Have Mandated Randomization

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iStock_000015967853SmallerCongress should have mandated randomization of drug serial numbers, but they did not, so it is up to each manufacturer to recognize the importance it would bring to the protection of their brands and of the supply chain.  Let me explain.

The text of the Drug Supply Chain Security Act (DSCSA) was developed last year by Congressional staff in consultation/negotiation with various lobbying organizations—primarily the Prescription Drug Security Alliance (PDSA).  The effect of the legislation is to create a way of protecting the U.S. pharmaceutical supply chain that relies primarily on product identifier authentication (PIA) (see “Product Identifier Authentication” and “The Aggregation Hoax and PIA”) for at least the first 10 years and possibly beyond. Continue reading DSCSA: Congress Should Have Mandated Randomization →

Randomization

Randomization—An Interview with Ken Traub—Part 5: Other Approaches

???????????????????This is the last of a five part interview with Ken Traub, GS1 standards expert and independent consultant, on GS1 serial number randomization.  The full series includes essays covering:

  1. GS1 Serial Number Considerations
  2. Properties of Randomization
  3. Threat Analysis
  4. Algorithmic Approach
  5. Other Approaches to Randomization (this essay)

This week Ken talks about other approaches to serial number randomization.  – Dirk. Continue reading Randomization—An Interview with Ken Traub—Part 5: Other Approaches →

Randomization

Randomization—An Interview with Ken Traub—Part 4: The Algorithmic Approach

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iStock_000016749706SmallerThis is the fourth installment of a five part interview with Ken Traub, GS1 standards expert and independent consultant, on GS1 serial number randomization.  The full series includes essays covering:

  1. GS1 Serial Number Considerations
  2. Properties of Randomization
  3. Threat Analysis 
  4. Algorithmic Approach (this essay)
  5. Other Approaches to Randomization

In this installment, Ken explains the algorithmic approach to serial number randomization.  – Dirk. Continue reading Randomization—An Interview with Ken Traub—Part 4: The Algorithmic Approach →

Randomization

Randomization—An Interview with Ken Traub—Part 3: Threat Analysis

Hacker typing on a laptopThis is the third of a five part interview with Ken Traub, GS1 standards expert and independent consultant, on GS1 serial number randomization.  The full series includes essays covering:

  1. GS1 Serial Number Considerations
  2. Properties of Randomization
  3. Threat Analysis (this essay)
  4. Algorithmic Approach
  5. Other Approaches to Randomization

This week Ken introduces the concept of threat analysis.  – Dirk. Continue reading Randomization—An Interview with Ken Traub—Part 3: Threat Analysis →

Randomization

Randomization—An Interview with Ken Traub—Part 2: Properties of Randomization

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iStock_000011797297SmallerThis is the second of a five part interview with Ken Traub, GS1 standards expert and independent consultant, on GS1 serial number randomization.  The full series includes essays covering:

  1. GS1 Serial Number Considerations
  2. Properties of Randomization (this essay)
  3. Threat Analysis
  4. Algorithmic Approach
  5. Other Approaches to Randomization

This week Ken introduces three properties of randomization.  — Dirk.

Continue reading Randomization—An Interview with Ken Traub—Part 2: Properties of Randomization →

Randomization

Randomization—An Interview with Ken Traub—Part 1: GS1 Serial Number Considerations

Ken Traub
Ken Traub

Over the next two weeks I have a very special treat for RxTrace readers.  It is an interview with Ken Traub, GS1 standards expert and independent consultant.  The subject is GS1 serial number randomization, something so important that I think pharma companies ought to give deep thought to it before they turn on their serial number applications.

Pharma manufacturer who sell into the E.U. and/or Brazil markets will be forced to randomize their serial numbers because of regulatory requirements, but even those who only sell into the U.S. market should strongly consider randomization.  I’ll have more to say about why in a follow-up essay after this series is over.

Because the interview with Ken covers the topic so thoroughly, it is long.  That’s good, because it provides readers with an easy to understand explanation of everything they need to know about randomizing.  But it also makes for a very long essay, so I have broken the interview down into five RxTrace essays.  Read sequentially, they contain the complete interview.  The subtopics covered by those essays include: Continue reading Randomization—An Interview with Ken Traub—Part 1: GS1 Serial Number Considerations →

DQSA of 2013

How the DQSA Will–And Won’t–Protect The Supply Chain, Part 2

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Superhero right to leftLast week I published an overly long essay about how the supply chain provisions of the new U.S. Federal DQSA will and won’t protect the pharma supply chain.  Believe it or not, I had more to say on the subject, but because that essay was already too long, I withheld my additional thoughts until now.  Part 1 took another look at a number of supply chain crimes that have occurred over the last 5 to 6 years and attempted to determine how the new Drug Supply Chain Security Act (DSCSA) that is contained within the DQSA will add new protections that will or won’t help prevent crimes like them in the future.

In this Part 2 essay I want to look at the issue in a different way.  I’d like to compare the approach that Continue reading How the DQSA Will–And Won’t–Protect The Supply Chain, Part 2 →