SAP Supply Chain Integrity Solutions for Pharmaceuticals

NNIT Announces Partnership with SAP to collaborate on IDMP

"NNIT collaborates with SAP to deliver leading IT software and services for identification of medicinal products (IDMP) tailored to improve the reporting and tracking of product safety."

COPENHAGEN, Denmark, Oct. 5, 2016 (GLOBE NEWSWIRE) -- NNIT, a global provider of IT services and consultancy, today announced a worldwide partnership with SAP SE, the market leader in enterprise application software, to market leading solutions supporting regulatory compliance for Identification of Medicinal Products (IDMP) within the pharmaceutical industry.
The European Medicines Agency (EMA) is implementing five new standards developed by the International Organization for Standardization (ISO). Pharmaceutical companies will be required to submit data on medicines to EMA in accordance with common global formats and terminologies. The penultimate goal as defined by the EMA is to improve overall patient safety.
Committed to support these new regulatory requirements, NNIT will introduce tailored, innovative solutions intended to secure successful IDMP compliance within the authority timelines. Read full Globe Newswire article here

Brazil Suspends Pharma Serialization And Tracing Requirements | RxTrace

"Last week, Brazil’s pharma industry regulatory agency, the National Agency of Sanitary Surveillance (ANVISA), announced that they were “suspending” at least part of RDC-54/2013, the declaration that mandated drug serialization and tracing, until further notice.  Thank you to all who forwarded the link to the official announcement.  I was able to translate and read it on Thursday, and I submitted a comment on my own last essay, “Pharma Serialization Deadlines In Flux“, to include the link.  Apparently shortly after that essay was published, ANVISA  publicly announced the suspension." Dirk Rodgers - Read the full article from Dirk here.

RxTrace.com: Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2015

Dirk Rodgers of rxtrace.com writes "It’s August and that means it is time to check in on the progress toward full serialization of drugs in the U.S. supply chain.  This is an annual look I’ve been doing for five years now.  For my previous essays, see:

• “Estimated Rise In Serialized Drugs In The U.S. Supply Chain”;
• “Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2011“;
• “InBrief: Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2012“;
• “InBrief: Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2013“;
• “InBrief: Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2014”.

In each essay I produced a graph of my own personal estimate of the likely rise in the percentage of drugs that I thought would result, based on the deadlines that were in place at the time.  Of course, things changed last year because the Drug Supply Chain Security Act had preempted the California Pedigree law the previous November, so last year I made a new estimate that took into consideration the DSCSA dates.

What GTIN would you use under this co-marketing scenario?

I saw this conversation on Linked In and felt that it was worthy to repost here for preserving...
Here’s the scenario:

A large multi-national manufactures and packages pharmaceutical finished goods. One presentation of these finished goods are sold in the US through a Partner (co-marketing arrangement). The Artwork and GTIN (NDC) of the product is that of the Partner. However the manufacturing authorization holder (MAH) is the large multi-national brand owner. With Serialization according to the DSCSA, should the GTIN remain that of the Partner? Or, would it need to revert to the MAH?
My belief is that it would not change – remain that of the Partner. Curious if you have come across this and if so, what approach you would take. 

Why serialization is vital for pharmaceutical product integrity in the cold chain

Read entire article at the Cold Chain View blog.

More than ever before, drug security is an important issue in ensuring the integrity of medicines and vaccines reaching patients. The industry needs to demonstrate that we care for patients, and are putting all necessary measures in place to ensure that medicines are safe to be taken.

That means knowing the entire journey of a medicine through the supply chain, and having fully automated documentation about the conditions on its journey. One of the ways in which this can be addressed in the cold supply chain is through serialization. A key driver for implementing serialization will be global compliance requirements coming into play. The USA introduced the Drug Supply Chain Security Act at the end of 2013, which will require the availability of information at individual package level about where a drug has been in the supply chain.

‘The Smallest Individual Saleable Unit’ In The DSCSA - RxTrace

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“).

SAP Business ByDesign Customization Use-Case: Approved Supplier Lists for Medical Device Manufacturer

SAP Business ByDesign Customization Use-Case: Approved Supplier Lists for Medical Device Manufacturer - A Blog by FMT Consultants.

"While SAP Business ByDesign has an extraordinary array of out-of-the-box functionality in both breadth and depth, there will always be customer-specific scenarios and use-cases that are not natively handled entirely through standard functionality. Though most ERP systems allow customization to handle these scenarios, what sets Business ByDesign apart is the ability to quickly and easily create custom functionality that can be an integral part of standard processes.

See also: Customizing SAP Business ByDesign to Your Needs

3PL Operation Under The DSCSA - RxTrace.com paper

Photo from Wikipedia

Dirk Rodgers has written another great article covering the impact on 3PLs when considering the DSCSA - Read the full article on RxTrace.com

Another type of business affected by the U.S. Drug Supply Chain Security Act (DSCSA) is the third party logistics provider (3PL) business.

I wrote an RxTrace essay about the impact of the California pedigree law on 3PLs back in 2013 (see “3PL Operation Under California ePedigree“).  This is an update of that essay to address the impacts of the new DSCSA on 3PLs since the California pedigree law is now obsolete.

There are a number of important differences between wholesale distributors and 3PLs as defined in the DSCSA.

Vendor Managed Inventory Under the DSCSA - RxTrace.com

Dirk Rodgers of RxTrace.com writes another interesting article around Vendor Managed Inventory and the impact of DSCSA on it.

FDA Warns of Bogus Botox - Case for SAP ATTP?

Counterfeit Botox may have been distributed to doctors' offices and medical clinics across the United States, the U.S. Food and Drug Administration warns.

The bogus Botox -- which is considered unsafe and should not be used -- was sold by an unlicensed supplier not authorized to ship or distribute drug products in the United States, the FDA said in a news release.

Packaging similarities between the fakes and the FDA-approved Botox, which is made by Allergan (100 units/vial), could cause health care professionals to mistake one for the other.

Approved Botox displays the active ingredient as "OnabotulinumtoxinA" on the outer carton and vial, the FDA said.

The outer carton of the counterfeit version says the active ingredient is "Botulinum Toxin Type A" instead of "OnabotulinumtoxinA," according to the agency.

The FDA said the counterfeit product also can be identified in other ways. For instance, the vial is missing the lot number.

Read full article here : http://mobile.philly.com/health/?wss=/philly/health&id=300685841

Why Does ANVISA Embrace GS1 Standards, Except The Serial Number? - By Dirk Rodgers

Dirk Rodgers of RxTrace.com has written another great article on ANVISA... Read below for an excerpt  or read the full article here. Serialization is a challenge and with this interpretation from the Brazilian authorities it certainly complicates matters for manufacturers if their goods land up in Brazil...

"In Brazil, the National Agency of Sanitary Surveillance (ANVISA) has built their pharma serialization regulation around GS1 standards. They embrace the GS1 Datamatrix and GS1-128, both encoded with GS1 Application Identifiers (AI) and using GS1 Human Readable Interpretation (HRI) (see my previous essay, “The ANVISA Unique Medicine Identifier (IUM) on Drug Packages”, for my thoughts on HRI), the GS1 Global Trade Item Number (GTIN) and the GS1 Serial Shipping Container Code (SSCC) to be specific. But there is one GS1 standard they steer clear of: the GS1 serial number. Why is that?

The ANVISA Unique Medicine Identifier (IUM) on Drug Packages - Dirk Rodgers

Last week Dirk wrote about the DSCSA Product Identifier on Drug Packages in the United States.  Last month he wrote about shipping container/transport package identification under the Brazil National Medicine Control System (SNCM) (see “ANVISA And The SSCC Controversy”).  In this article Dirk takes a look at drug package identifiers under the SNCM as regulated by the National Agency of Sanitary Surveillance (ANVISA).  Dirk is a member of the GS1 Healthcare group - Contact GS1 Healthcare for more information.

An excerpt from Dirk's article:

"Under the SNCM, manufacturers must apply a Unique Medicine Identifier (IUM) to all drug packages imported or sold into the Brazilian supply chain and trace them through the supply chain by December 11, 2016.  By December 11 of 2015, manufacturers must apply the IUM to the packages of at least three lots of drugs and trace them to the dispensing points.  And you thought compliance with the DSCSA was going to be hard to achieve!

The DSCSA Product Identifier On Drug Packages - Dirk Rodgers

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:

“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])

Frequentz Inc's Track and Trace Solution news

PALO ALTO, Calif., April 28, 2015 - As the counterfeit drug market grows and the pharmaceutical supply chain becomes more complex, Frequentz Inc., a global leader and champion of end-to-end visibility, is proud to announce they are validating medications flowing through two-thirds of the 67,000 U.S. pharmacies. Frequentz's track and trace system is utilized by two of the top three global distributors of pharmaceuticals, increasing Frequentz's ability to help keep consumers safe. With such broad reach, Frequentz gives consumers the confidence they can trust the medications coming from the majority of pharmacies and contract manufacturers.

Read full article at PR Newswire

5th Traceability and the Drug Quality and Security Act - ExL Events

5th Traceability and the Drug Quality and Security Act - An ExL Event

5th Traceability and the Drug Quality and Security Act– 5th Traceability and the Drug Quality and Security Act

Join us in Morristown, New Jersey at the 5th Traceability and the Drug Quality and Security Act conference to learn from leading supply chain experts about they have managed to provide business value through serialization and pedigree beyond regulatory compliance. Make sure you have everything in place to be able to respond to FDA inquiries within 48 hours to avoid high fines and work effectively together with your wholesalers and dispensers. This interactive forum discusses best practices for track and trace and lessons learned from implementing an integrated global supply chain security program that improves transparency, secures your supply chain and protects your brand, all while leveraging business benefits.

Identification Of Pharma Cases In The U.S. - Dirk Rodgers

Article from Dirk Rodgers - "Last 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 contains units from a single NDC and all units are from a single packaging lot. The product identification label should not be confused with a shipping/logistics label, which, if it exists, is applied at the time of shipment and contains information about the destination.

Typically, cases that are shipped from a higher-volume manufacturer to a larger wholesale distributor will be placed onto a pallet. The pallet often has cases of multiple products, and even different homogeneous cases of the same product can contain different lot numbers. You can sometimes even find a Non-homogeneous case mixed in with the homogeneous cases. Further, cases on the same pallet can actually be fulfilling different purchase orders submitted by the buyer. All of these variations complicate the job of the receiving clerk." - Read full article at RxTrace.com

California Board of Pharmacy Issues Licensing Guidance for 3PLs

The California Board of Pharmacy issued guidance this week outlining the process for obtaining the licensing as third-party logistics providers or non-resident third-party logistics providers in the state. This requirement extends to all 3PLs that ship pharmaceuticals to or from California.
Prior to the Drug Supply Chain Security Act (DSCSA), 3PLs were required to obtain licensing as a wholesaler—now 3PLs and wholesalers are separate entities under California law.
Read the full story at IWLA

US FDA Amends eMDR Rules to align with Unique Device Identification Program - Posted on RAPS

US medical device regulators at the Food and Drug Administration (FDA) have issued correcting amendments to their post-market electronic Medical Device Reporting (eMDR) requirements to eliminate any disparities between those rules and their Unique Device Identification (UDI) system.

All changes will affect federal regulation 21 CFR Part 803 covering medical device reporting. Among the changes in the FDA final rule are requirements for what manufacturers, user facilities and importers should include in adverse event reports: identifying device number such as model, catalog, serial or lot number; expiration date; and UDI appearing on device label or package.


View full article on RAPS -> US FDA Amends eMDR Rules to align with Unique Device Identification Program

Pharma Serialization Update - April

Bill Fletcher highlights a few key deadlines looming for Pharma Serialization:

1. The FDA enforcement discretion not to enforce the transaction document aspects of the Drug Supply Chain Security Act (DSCSA) ends May 1. Companies who may have chosen to spend more time working out kinks in their transaction document (TD) may be running out of time.  
2. There is controversy with the way shipper cases are tracked in Brazil.
3. Companies selling into Brazil will now need to collect traceability data from 3 LOTs by December of this year. 
4. Chinese traceability is fully effective this December.  
5. New requirements in India for primary packages are creating very onerous designs on manufacturers
6. EU delegated acts for Falsified Medicines is expected in the next couple of months. Encoding will include GTIN, country reimbursement code, LOT expiration date and serial number in human readable and encoded in a GS1 DataMatrix symbol

Bill Fletcher - Pharma-Logic