Tag Archives: pharma manufacturer

standards

The Open Serialization Communication Standard (Open-SCS)

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open-scs-logo2-300x289Most RxTrace readers are at least aware of GS1 standards.  GS1 is an international non-profit membership organization that facilitates the development and maintenance of technical standards that are intended for use within supply chain operations and interactions.  GS1 standards are used in many supply chains including pharma.  GS1 standards are playing an indispensable role in the implementation of pharma serialization, including their GTIN, GLN, SSCC, Datamatrix, application identifier and EPCIS standards.  I have written frequently about GS1 and these specific standards (see “GS1”).

But today I want to draw your attention to a different standards development organization Continue reading The Open Serialization Communication Standard (Open-SCS) →

CMO/CPOs

Lack Of Preparedness By CMO’s Imperils Pharma Manufacturers

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Somethings Gotta GiveEverywhere I traveled this fall I had conversations with people from drug manufacturers who told me their top concern right now is that their contract manufacturers (CMOs) or contract packagers (CPOs) are not taking the actions necessary to be prepared to meet the approaching serialization mandates in the U.S., the E.U. and elsewhere on time.  This threatens the manufacturer’s ability to be ready for those deadlines and they are grasping for something they can do now to fix the situation before it gets too late…if it isn’t too late already. Continue reading Lack Of Preparedness By CMO’s Imperils Pharma Manufacturers →

DSCSA

Again, Should You Off-Load Your DSCSA Obligations To Your Contract Partners?

??????????????????????I spent my holiday weekend having fun with my family and I hope you did the same.  Instead of spending my holiday writing a new RxTrace essay I am re-running one of my better essays, originally posted on October 6, 2014.  If you missed it then, or even if you read it then, it is worth another read.  See if you agree:

Manufacturers who make use of third-party contract manufacturers, contract packagers and/or third-party logistics providers (3PLs) may wish to off-load their 2015 and 2017 obligations under the U.S. Drug Supply Chain Security Act (DSCSA) to those contract organizations.  These obligations include Continue reading Again, Should You Off-Load Your DSCSA Obligations To Your Contract Partners? →

DSCSA Product Identifier, serialization

InBrief: ‘The Smallest Individual Saleable Unit’ In The DSCSA

Drawing from the GS1 Healthcare GTIN Allocation Rules document showing how to assign GTINs in multi-pack scenarios. Click image to enlarge.
Drawing from the GS1 Healthcare GTIN Allocation Rules document showing how to assign GTINs in multi-pack scenarios. Click image to enlarge.

The U.S. Drug Supply Chain Security Act (DSCSA) requires manufacturers and repackagers to place DSCSA-specific “product identifiers” on all drug packages and homogeneous cases by November 27, 2017 (2018 for repackagers).  These product identifiers must include a Standardized Numeric Identifier (SNI), which is composed of the drugs National Drug Code (NDC) and a unique serial number (for more on DSCSA “product identifiers”, see “The DSCSA Product Identifier On Drug Packages“, for more on the SNI, see “FDA Aligns with GS1 SGTIN For SNDC“, and for more on the NDC, see “Anatomy Of The National Drug Code“).

A common question is, what is the smallest level of packaging that must be serialized?.  The DSCSA text provides the answer. Continue reading InBrief: ‘The Smallest Individual Saleable Unit’ In The DSCSA →

DSCSA Product Identifier

The DSCSA Product Identifier On Drug Packages

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DSCSA Product IdentifierAccording to the Drug Supply Chain Security Act (DSCSA), manufacturers must apply a new “Product Identifier” on all of their prescription drug products by November 27, 2017 (Repackagers by that date in 2018).  The DSCSA Product Identifier is defined this way:

“PRODUCT IDENTIFIER.—

The term ‘product identifier’ means a standardized graphic that includes, in both human-readable form and on a machine-readable data carrier that conforms to the standards developed by a widely recognized international standards development organization, the standardized numerical identifier, lot number, and expiration date of the product.”  (Section 581[14])

Continue reading The DSCSA Product Identifier On Drug Packages →

SSCC

Identification Of Pharma Cases In The U.S.

5 BoxesLast week I discussed controversy over the use of GS1’s Serial Shipping Container Code (SSCC) in the Brazil pharma supply chain to meet regulatory requirements imposed by ANVISA.  But there are different controversies, or at least potential confusion, in the U.S. pharma supply chain surrounding case labels, and some of those are relate to the SSCC and its use.

A case product identification label is the label a manufacturer usually places on each homogeneous case at case-packing time to identify what is inside the corrugated box.  A “homogenous case” is a case that Continue reading Identification Of Pharma Cases In The U.S. →

RxTrace Traceability Survey

2015 RxTrace U.S. Pharma Traceability Survey Results, Sponsored by Frequentz Now Available!

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graphI am proud to announce the free availability of the 2015 RxTrace U.S. Pharma Traceability Survey Results, sponsored by Frequentz.  You can download the new free report here.

This year’s results were very interesting because most of the responses came in during the critical time just before the 2015 DSCSA requirements were to go into effect.  The questions asked were designed to elicit opinions on a wide range of topics, including the respondent company’s ability to meet the regulations on time, their technology choices and practices.  This year Continue reading 2015 RxTrace U.S. Pharma Traceability Survey Results, Sponsored by Frequentz Now Available! →

Aggregation

When Will The DSCSA Ever Require Investments In Aggregation?

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Packaging Hierarchy. Drawing by Omega Design
Packaging Hierarchy. Drawing by Omega Design

I have been outspoken on the question of whether or not the Drug Supply Chain Security Act (DSCSA) requires companies in the supply chain to provide their customers with serial number-based aggregation data prior to 2023.  In my view, it does not, but others disagree, saying that there are requirements in the law that lead to the need for aggregation data during that time.  I do not agree with that either.  If you would like to review those arguments and find out exactly what “aggregation data” is, here is a list of RxTrace essays you should read:

Date Published Title/link
March 26th, 2012 Pharma Aggregation: How Companies Are Achieving Perfection Today
November 22nd, 2013 DQSA: Will U.S. Pharma Distributors Mandate Aggregation Data In Phase 1?
February 10th, 2014 Does The DQSA Require Manufacturers To Provide Aggregation Data? Survey Says…
June 9th, 2014 The Aggregation Hoax and PIA

BUT WHAT ABOUT AFTER 2023?

The DSCSA requires the FDA to conduct at least 5 topical public meetings between now and Continue reading When Will The DSCSA Ever Require Investments In Aggregation? →