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Introduction To Serialization and ATTP

This document discusses counterfeit drugs and serialization solutions. It provides an overview of how serialization works by printing unique identifiers on drug packages to improve traceability. This helps reduce counterfeits and recall issues while improving supply chain efficiency. The document also describes GS1 standards for identification keys and how SAP ATTP software can help pharmaceutical companies comply with regulations by managing serialization and tracing drugs through the supply chain.

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Rahul Gupta
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255 views25 pages

Introduction To Serialization and ATTP

This document discusses counterfeit drugs and serialization solutions. It provides an overview of how serialization works by printing unique identifiers on drug packages to improve traceability. This helps reduce counterfeits and recall issues while improving supply chain efficiency. The document also describes GS1 standards for identification keys and how SAP ATTP software can help pharmaceutical companies comply with regulations by managing serialization and tracing drugs through the supply chain.

Uploaded by

Rahul Gupta
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd
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Introduction:

Serialization and
ATTP
Counterfeit Drugs
Counterfeit Drugs
• Counterfeit goods are duplicate items, typically of inferior quality and deliberately made to look genuine.
Counterfeit products are often produced with the intent to take advantage of the superior value of the
imitated product.
Impact of
Counterfeit Drugs
• Ultimate Victim is consumer
• Inferior quality
• Health
• Safety Concerns
• Loss of consumer and public trust
• Brand Damage
• Ineffective product recall and return
logistics
• Government lose out on unpaid taxes
Introduction to Serialization
• Serialization means to make each unit unique by printing a unique identifier on each item. An item identifier is
a Data matrix code which contains product information. Product information includes GTIN paired with serial
number, batch number, product description etc.
Business Benefits
• Product traceability in complex global
supply chain logistics efficiency
• Legal compliance with national, regional or
global regulations
• Greater revenue share by reducing the
“Gray Market” activity
• Trace data on every single unit, resulting to
visibility to most granular level.
• Fast and efficient reverse logistics or recall
processes
• Better product authentication and integrity
Serialization Regulations
Serialization Components
Serialization Solution Providers
GS1 Standards
• GS1 is an organization dedicated to the design and implementation of global standards for use in supply
chain
• GS1 standards are an agreement that structures any activity or any industry. This may be rules or
guidelines.
• GS1 provides identification keys to identify goods, locations etc. worldwide.
• It is the most widely used supply chain standards in the world.
• GS1 standards include GCP, GLN, GTIN, SSCC.
GS1 Glossary
• Global Trade Item Number (GTIN)
The GTIN is a unique identification key that can be used globally to identify the item. It may be produced as a GS1 bar code or held
in a GS1 EPC tag.

• Serialized Shipping Container Code (SSCC)


The SSCC is used to identify individual logistics unit. A logistics unit can be any combination of units put together in a case or on a
pallet or truck where the specific unit load needs to be managed through the supply chain

• Global Location Number (GLN)


The globally unique GS1 System Identification number for legal entities, functional entities, and physical locations. The GLN is 13 digits,
comprised of variable length GS1 company prefix, location reference, and check digit

• Global Company Prefix (GCP)


The GCP is a unique identification key for companies. It varies from 7 to 9 digits in length. It is a combination of GS1 country prefix and
company number
GS1 Application Identifiers
• GS1 Application Identifiers are used to represent a way to encode information.

• It is also called Human Readable Format.

(01) GTIN
(21) Serial Number
(17) Expiry Date (01)1234564321234(21)22331123
(10) Batch Number (17)200625 (10)989765

• Other Identifiers:

(00)6756453465787654575 - SSCC
EPCIS (Electronic Product Code Information Services)
• It stands for Electronic Product Code Information System.

• It’s a GS1 standard that is used to share information with supply chain
partners.
Serialization Packaging Hierarchy
SAP Solutions
• SAP Auto ID Infrastructure and SAP Object Event Repository

• SAP Advance Track and Trace for Pharmaceuticals


SAP ATTP
ATTP is SAP’s the state-of-the-art solution for Serialization based on the newest technology HANA and Fiori and the
leading Level 4 solution for big pharma companies.

Generally, ATTP covers all functions


 Master data management
 Serial number replenishment
 Reporting of serialized batches
 Reporting to health authorities
 Data exchange with supply chain partners (CMO, CMB, 3PL)
Basic Architecture
Process Flow
Integration with ECC
• Master Data maintenance and integration
• Customers and Vendors are integrated as Business Partners
• Plants and Storage locations are integrated as Locations
• Material master is enhanced and Materials are integrated as Trade Items
• Trade item serialization attributes can be maintained in a separate transaction

• Transactional Data Integration


• Production orders and process orders are integrated
• Inbound deliveries, outbound deliveries and return deliveries are integrated
• Batch is enhanced and Batches are integrated

• Warehouse Toolbox
Integration with Packaging Lines
• Serial Number Management

• Commissioned data
• PML and EPCIS message capture
Pharma Network (SAP ICH)
Takeda Serialization Project

UPI (Unique Product Identification)


UPI Architecture
others

L5 Network systems
US DSCSA
EU FMD SAP ICH / VRS

L4 Enterprise systems Aii/OER


ATTP

L3 Site control systems Guardian CMOs

L2 Line control systems Advisor Advisor Advisor

L1 Devices and controllers


UPI Workstreams
• Workstream 1 : Internal Site Integration

• Workstream 2: Regulatory Reporting

• Workstream 3: External Site Integration

• Workstream 4: Data Migration


Thank You

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