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Drug Quality and Security Act
A bill that would modify the Federal Food, Drug, and Cosmetic Act to grant the Food and Drug Administration more authority to regulate and monitor the manufacturing of compounded drugs.
The bill was written in response to the New England Compounding Center meningitis outbreak that took place in 2012, which killed 64 people.[2] The bill was signed by President Obama on November 27, 2013.
What Is The New Act?
The Drug Quality and Security Act adds additional requirements that are causing pharmaceutical companies to adjust their serialization strategies and implementation timelines.
By 2015, manufacturers must…
Incorporate product transaction data into a single document in every transferred ownershipmust include transaction data listing lot-level informationcomplete transaction historytransaction statement and must be maintained for 6 years after the transaction
By November 2017, this information must be available electronically, and the product identifier must be affixed or imprinted on the label at the product and case level.
“A wait-and-see approach will not leave us much time to implement a proper solution,”
- -Stephen Kovary, senior director, operational excellence in supply chain - and technical operations at Daiichi Sankyo, Inc.
What It Means For Pharmaceutical Companies?
The data required for serialization should be in demand throughout the supply chain. High level of tracking will allow companies to use the data to gain more comprehensive understanding of their entire supply chain and help minimize distribution bottlenecks and tightly target recalls.
“The companies that will succeed are those with concurrent strategies to meet the requirements and to extract value by increasing visibility into the global supply chain, don’t lose sight of longer-term efforts. Think about ways to extract value from these investments.”
-Hussain Mooraj, Global Lead Life Sciences Supply Chain & ERP at Accenture
Increasing Serialization Visibility
SAP Advanced Track and Trace
The Right Solution To Meet These Requirements…
Market Requirements
© 2015 SAP SE or an SAP affiliate company. All rights reserved. 7Customer
International legislation fighting the counterfeiting/ falsification of medicinal drugs requiring serialization
1In response to and with the aim to counter the large scale counterfeiting/ falsification of medicinal drugs, international governments have implemented, enacted or are planning to draft legislation calling for the serialization and reporting of medicinal drugs to improve patient safety.
© 2015 SAP SE or an SAP affiliate company. All rights reserved. 8Customer
The implementation of these legislations require serial numbers be encoded in 2-D barcodes
2
GTIN (Global Trade Item Identification Number)
Expiration Date (YYMMDD) Batch or Lot Number Serial Number
Source: 2-D Matrix barcode courtesy of GS1 Germany
Serialized trade item information is contained in a 2-D barcode (GS1 Data Matrix) which is applied to medicinal sales unit packages, in some cases also to their aggregations to bundles, cases and then pallets - either for compliance or logistical reasons.
The 2-D barcode typically contains the following elements: Global Trade Identification Number (GTIN) Expiration date Batch/ lot Number Serial number
The implementation of these legislations require serial numbers be encoded in 2-D barcodes
© 2015 SAP SE or an SAP affiliate company. All rights reserved. 9Customer
Overview of legislation and reporting
3
Serialization with reporting to a governmental database
Uploading serialized trade items into an institutional hub for
verification
Initially lot traceability – then full supply chain track & trace of
serialized trade items
in effect
expected
enacted enacted & partially in force
• Lot traceability in force• Serialization required by 2017• Full serialized track & trace by 2023
EU: affects ~25% of global pharmaceutical
sales
US: affects ~30% of global pharmaceutical
salesChina: affects ~15% of
global pharmaceutical
sales
Presently there are 3 types of compliance requirements
© 2015 SAP SE or an SAP affiliate company. All rights reserved. 10Customer
Requirements posited on Pharma Manufacturers and the Pharma Value Chain
4
1. Global serial number management2. Serialization at packaging lines3. Efficient process integration as this become part of “normal business”4. Dealing with serial number volumes requiring a scalable serial number
repository5. Efficient reporting to different country reporting requirements regimes
© 2015 SAP SE or an SAP affiliate company. All rights reserved. 11Customer
Resulting key business challenges
4
3
How do I efficiently manage my global serial number pool?2
How do I efficiently comply with many country-specific compliance and reporting requirements on drug trade item serialization?1
5
How do I efficiently integrate serialization with my business processes and systems?
How do I efficiently message serialization data to my business partners?
How do I scale with the expected data volume arising from serialization?
Why SAP Advanced Track and Trace for Pharmaceuticals?
© 2015 SAP SE or an SAP affiliate company. All rights reserved. 13Customer
Goal: compliance to regulations that seek a safe and secure supply chain across the pharmaceutical value chain to ensure patient safety
CMO, 3PL Are often small companies
with limited IT capabilities Need to manage externally
generated serial numbers Ensure timely and correct communication to
customers
Wholesalers (US and elsewhere) Work with huge volumes (1mio – 10b
units/year) May require very limited functional scope WM-integration is a key aspect
MAH Are ultimately responsible for brand protection Need to manage external (for example,
China) and internal serial numbers Often act as CMO also to Large
Pharma Manufacturers
Pharma MAH
Contractmanufacturers
3PL
Regulatory authorities
Wholesaler
Request and receiveserial numbers (lists and
ranges) from MAH
Send serial number status information -
send commissioned serial numbers
Send regulatory reporting messages to authorities
Send messages to wholesalers
LegendMAH: market authorization holder (brand owner/ OEM) | CMO: contract manufacturing organization | 3PL: third-party logistics provider
CMO to MAH integration
Packaging line integration
Warehouse operations
Audits and internal reporting Compliant messaging
© 2015 SAP SE or an SAP affiliate company. All rights reserved. 14Customer
Why Customers asked us to invest into SAP Advanced Track and Trace for Pharmaceuticals?
During the period of 2012 – 2013, SAP received several requests from the Pharma Customer installed base of SAP Auto-ID Infrastructure/ SAP Object Event Repository to bring SAP Solutions for serialization in Pharmaceuticals to the next level.
Reasons• Demand/ requirements for more focused Pharma specific functionality (e.g.
master data, integration objects, process integration)
• Request for country reporting packages and associated functionality
• Scaling for the expected volume
• Severe concerns as to alternatives in the market place as to viable solutions on which one can place a bet for must do compliance to retain the right to sell into regulated markets
© 2015 SAP SE or an SAP affiliate company. All rights reserved. 15Customer
Why SAP Advanced Track and Trace for Pharmaceuticals?
Simplify regulatory reporting, to comply with international directives
Efficiently integrate serialization with business processes and your business network: master data, warehouse operations and supply chain partners
Effectively manage BIG DATA arising from the ever-growing number of countries that mandate serialization
© 2015 SAP SE or an SAP affiliate company. All rights reserved. 16Customer
How SAP Advanced Track and Trace for Pharmaceuticals delivers value
SAP Advanced Track and Trace for Pharmaceutical integrates with your supply chain network
Readily available country reporting packages
ERP Master data integrationIntegration with ERP transactions
& batches / lotsIntegration to WMS operations
Integrate serialization into your business processes
Manage expected steep increase in serialization data
volume
Simplify regulatory reporting
A single scalable platform Delivery of lean object/ event data model designed for performance
and expected volumes
Out of the box business partner integration (Contract Manufacturing Organizations ↔ Market Authorization Holders ↔Wholesalers): request/ response on serial number requests, supply chain partner notification with
eASN or EPCIS XML
© 2015 SAP SE or an SAP affiliate company. All rights reserved. 17Customer
Benefits: SAP Advanced Track and Trace for Pharmaceuticals
Effectively comply with global serialization requirements,
including different formats and country-specific reporting from a
single corporate serialization repository.
Benefit from efficient integration of a corporate-level
pharmaceutical serialization solution with your business processes and supply chain
network, while reducing TCO and compliance cost.
Efficiently scale with a pharmaceutical solution capable
of handling large serialization data volumes.
Comply Cost Scale
Reduce cost/ TCO of compliance
Reduce cost of business process integration
Reduce cost of platform operation – future proof
investment
© 2015 SAP SE or an SAP affiliate company. All rights reserved.
Thank you
For more information please contact your local SAP Account Executive.
Eric BenderAccount ExecutiveP: (202)580-5129E: [email protected]