Most 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”).
Everywhere 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→
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:
According 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:
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)
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:
…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance
DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer. The reader must make their own decisions about the accuracy of the opinions expressed in RxTrace. Readers are encouraged to consult their own legal counsel and trading partners before taking any actions based on information found in RxTrace. RxTrace is not a vehicle for communicating the positions of any company, organization or individual other than Dirk Rodgers.