Drug Quality and Security Act

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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.


The implementation of these legislations require serial numbers be encoded in 2-D barcodes

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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


Overview of legislation and reporting

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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


Requirements posited on Pharma Manufacturers and the Pharma Value Chain

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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


Resulting key business challenges

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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?


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


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


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


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


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]

Drug Quality and Security Act

Health & Medicine

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