GHSC-PSMGlobalStandardsTechImpGuide V1.0 FINAL

USAID GLOBAL HEALTH SUPPLY CHAIN PROGRAM
PR O CURE ME NT AND S UPPLY MANAGEMENT
GLOBAL STANDARDS TECHNICAL

IMPLEMENTATION GUIDELINE
Product and Location Identification, Labeling, and Data
Exchange
Version 1.0, January 2018

GLOBAL STANDARDS TECHNICAL
IMPLEMENTATION GUIDE
Product and Location Identification, Labeling, and Data
Exchange
Version 1.0, January 2018
This publication was produced for review by the United States Agency for International Development. It
was prepared under the USAID Global Health Supply Chain Program-Procurement and Supply
Management (GHSC-PSM) Contract No. AID-OAA-I-15-00004; Task Order 01 Contract No. AID-OAA-
TO-15-00007; Task Order 02 Contract No. AID-OAA-TO-15-00009; Task Order 03 Contract No. AID-
OAA-TO-15-00010; and Task Order 04 Contract No. AID-OAA-TO-15-00018.
Recommended citation: USAID Global Health Supply Chain Program-Procurement and Supply
Management Single Award IDIQ. 2018. Global Standards Technical Implementation Guideline.
Washington, D.C.
DISCLAIMER
The authors’ views expressed in this publication do not necessarily reflect the views of the
U.S. Agency for International Development or the U.S. government.
CONTENTS
ACRONYMS ...................................................................................................................................... 2
REVISION HISTORY ....................................................................................................................... 3
INTRODUCTION ............................................................................................................................. 4
OVERVIEW OF THE REQUIREMENT FOR PHARMACEUTICALS ........................................ 6
OVERVIEW OF THE REQUIREMENT FOR MEDICAL DEVICES, STERILE KITS, AND

LABORATORY REAGENTS ........................................................................................................... 7
DESCRIPTION OF PACKAGING LEVELS ................................................................................... 8

Tertiary Packaging ...................................................................................................................................... 8
Secondary Packaging .................................................................................................................................. 9
Primary Packaging .....................................................................................................................................11
OVERVIEW OF GS1 STANDARDS USED ................................................................................. 12
Identify ........................................................................................................................................................ 12
AI (00) Serial Shipping Container Code (SSCC)C .................................................................................... 12
AI (01) Global Trade Item Number (GTIN) .............................................................................................. 12
AI (10) Batch/lot ............................................................................................................................................... 13
AI (17) Expiration date ................................................................................................................................... 13
AI (21) Serial number...................................................................................................................................... 13
Global Location Number (GLN) .................................................................................................................... 14
Capture ....................................................................................................................................................... 15
GS1-128 Barcode ............................................................................................................................................. 15
GS1 DataMatrix ............................................................................................................................................... 16
Share ............................................................................................................................................................ 16
Master Data ....................................................................................................................................................... 16
Transaction Data .............................................................................................................................................. 17
Event Data .......................................................................................................................................................... 17
IMPLEMENTATION PROCEDURES ........................................................................................... 18
RESOURCES ................................................................................................................................... 20
Transition Guidance................................................................................................................................. 20
GHSC-PSM Resources ............................................................................................................................ 20
GS1 Resources.......................................................................................................................................... 20
GDSN Resources ..................................................................................................................................... 20
ANNEX A: GLOSSARY OF TERMS ............................................................................................. 21
ANNEX B: FREQUENTLY ASKED QUESTIONS ...................................................................... 24

Section 1: Identify ..................................................................................................................................... 24
Section 2: Capture ................................................................................................................................... 29
Section 3: Share ........................................................................................................................................ 32
Section 4: Additional Questions ........................................................................................................... 35
Global Standards Technical Implementation Guide | i

ACRONYMS
AI ............................................................................................................................. GS1 Application Identifier
AIDC .......................................................................................... automatic identification and data capture
ASAP ...................................................................................................................................as soon as possible
ASN ................................................................................................................................. advanced ship notice
CBV........................................................................................................................ Core Business Vocabulary
EDI ....................................................................................................................... electronic data interchange
EPCIS ............................................................................... Electronic Product Code Information Services
ERP.....................................................................................................................enterprise resource planning
FAQ ........................................................................................................................ frequently asked question
IEC............................................................................................ International Electrotechnical Commission
ISO ...................................................................................................... International Standards Organization
IT ...................................................................................................................................information technology
GDSN............................................................................................. Global Data Synchronization Network
GHSC .................................................................................................................. Global Health Supply Chain
GLN ......................................................................................................................... Global Location Number
GSMP ............................................................................................. Global Standards Management Process
GTIN ................................................................................................................... Global Trade Item Number
HRI ................................................................................................................. human readable interpretation
MIS ..............................................................................................................management information system
MO ........................................................................................................................ GS1 Member Organization
NLT................................................................................................................................................. no later than
PSM ...................................................................................................Procurement and Supply Management
RDC ..................................................................................................................... regional distribution center
RFID .................................................................................................... radio frequency identification device
SSCC ............................................................................................................... serial shipping container code
SDP ................................................................................................................................. service delivery point
SKU ....................................................................................................................................... stock keeping unit
TDM.......................................................................................................... technical direction memorandum
USAID ................................................................................... U.S. Agency for International Development
GHSC-PSM Global Standards Technical Implementation Guide | 2

REVISION HISTORY
Date Version no. Description of change Author
Jan 1, 2018 1.0 Initial document K. Roche

SECTION NO. 1
INTRODUCTION
Chemonics is acting on behalf of the U.S. Agency for International Development (USAID) to implement
the Global Health Supply Chain-Procurement and Supply Management (GHSC-PSM) project. The
purpose of the project is to:
• Serve as the primary vehicle through which USAID will procure and provide health commodities
for all USAID health programs, including but not limited to HIV/AIDS, Malaria, Reproductive
Health, and Maternal and Child Health
• Provide systems strengthening technical assistance to improve supply chain management and
commodity security in partner countries
Through the project, lifesaving health commodities will be delivered to many of the world’s most
vulnerable people.
USAID TECHNICAL DIRECTION

For many years, USAID has been investigating the use of global standards to improve the management of
health commodity procurements. Through a technical direction memorandum (TDM) issued on April
25, 2017, USAID has instructed GHSC-PSM to:
• Develop a contract requirement for implementing global standards for product identification,
labeling, and data exchange
• Seek to harmonize requirements and implementation timelines with other global stakeholders
• Design its management information system to support and exchange data leveraging global
standards
• Support country governments in regulating global standards, product authentication, and track-
and-trace solutions
ABOUT THE GHSC-PSM REQUIREMENT

In response to the TDM, on May 15, 2017, GHSC-PSM issued a notice to suppliers announcing the
implementation of global standards for product identification, labeling, and data exchange.1 Under this
new requirement, all pharmaceuticals, medical devices, sterile test kits, and reagents should be identified
and labeled at various packaging levels using the GS1 system of standards.
GHSC-PSM developed this requirement to address challenges in supply chain data visibility, supply chain
efficiency, and supply chain security in the GHSC-PSM global supply chain and the national supply chains
of USAID-supported country programs. Implementing global standards will enable these stakeholders to
develop automation, authentication, and track-and-trace solutions to address these issues, which will
1
Announcement of Intention to Implement Global Standards for Product Identification, Labeling, and Data Exchange.
https://www.ghsupplychain.org/sites/default/files/2017-
05/PSM_Announcement%20of%20Global%20Standards%20Contract%20Requirements_FINAL.pdf

benefit stakeholders across the supply chain, from manufacturers to patients, including procurement
agencies, wholesalers, distributors, importers, and healthcare providers. Adopting globally harmonized
standards for product identification and data exchange is a critical step in addressing these issues.
The requirement mandates the use of product serialization for pharmaceuticals at the trade packaging
level, both secondary and tertiary. Serialization enables implementation of a comprehensive system to
track and trace the movement of drugs through the entire supply chain. By identifying every product
with a globally unique product number (Global Trade Item Number® (GTIN®)), and by capturing
information on its expiration date, batch/lot number, and unique serial number (where applicable), the
product’s lifecycle can be tracked from production to distribution across borders, all the way to its
dispensation to patients at a hospital, clinic, pharmacy, or other service delivery point.
In addition to the identification and labeling requirements outlined in the specifications,

manufacturers/brand owners/responsible entities will submit product master data to GHSC-PSM
through the GS1 Global Data Synchronization NetworkTM (GDSN®).
ABOUT THIS DOCUMENT

The GHSC-PSM Global Standards Technical Implementation Guideline is a resource developed for
GHSC-PSM trading partners to inform the implementation of contract requirements for product and
location identification, labeling, and data exchange. GHSC-PSM recommends using the GS1 General
Specification as the primary reference document for technical specifications to meet the requirement in
accordance with GS1 global standards.
DISCLAIMER
In any document that speaks to procurement requirements, each company is also individually
responsible for meeting all statutory and/or regulatory requirements for the company and its products.
Consult with your company’s legal counsel or compliance team (regulatory or quality) for more specific
information about statutory and regulatory requirements on a country-by-country basis beyond those
detailed in this document.

SECTION NO. 2
OVERVIEW OF THE REQUIREMENT FOR

PHARMACEUTICALS
The requirements specify the following minimum use of GS1 identification keys and data carriers
labeled on pharmaceutical products at various packaging levels:
Packaging Packaging Human readable

Requirement Timeline
level type interpretation (HRI)
Tertiary: logistic unit GS1-128 barcode2 Information printed in As soon as possible

symbology encoded human readable format: (ASAP) but no later
with: • SSCC than (NLT) June 30,
• Serial shipping 2022
container code
(SSCC)
Tertiary: trade Homogenous GS1 DataMatrix or Information printed in For GTIN, batch/lot,
item GS1-128 barcode human readable format: and Expiration date,
symbology encoded • GTIN ASAP but NLT
with: • Batch/lot December 30, 2018
• GTIN • Expiration date
• Batch/lot • Serial number For serial number, NLT
• Expiration date June 30, 2022
• Serial number
Mixed or GS1-128 barcode3 Information printed in ASAP but NLT June 30,
partial symbology encoded human readable format: 2022
with: • SSCC
• SSCC
Secondary: trade item GS1 DataMatrix Information printed in For GTIN, batch/lot,
symbology encoded human readable format: and Expiration date,
with: • GTIN ASAP but NLT June 30,
• GTIN • Batch/lot 2020
• Batch/lot • Expiration date
• Expiration date • Serial number For serial number,
• Serial number ASAP but NLT June 30,
2022
Primary: trade Item GS1 DataMatrix Information printed in Optional
symbology encoded human readable format:
Optional; Required only when with: • GTIN
the product is supplied in carton- • GTIN • Batch/lot
less packaging. • Batch/lot • Expiration date
• Expiration date • Serial number
• Serial number
2
If and when the GS1 DataMatrix is recommended for use on the logistic unit in the GS1 General Specification, suppliers are permitted to use
that data carrier to meet the GHSC-PSM logistic unit labeling requirement.
3

SECTION NO. 3
OVERVIEW OF THE REQUIREMENT FOR

MEDICAL DEVICES, STERILE KITS, AND
LABORATORY REAGENTS
The requirements specify the following minimum use of GS1 identification keys and data carriers
labeled on medical devices, sterile kits, and laboratory reagents at various packaging levels:
Packaging Packaging
Requirement HRI Timeline
level type
Tertiary: logistic unit GS1-128 barcode4 Information printed in ASAP but NLT June 30,
symbology encoded with: human readable format 2022
• SSCC • SSCC
Tertiary: Homogenous GS1 DataMatrix or GS1- Information printed in ASAP but NLT
trade item 128 barcode symbology human readable format: December 30, 2018
encoded with: • GTIN
• GTIN
And when applicable:
And when applicable: • Batch/lot
• Batch/lLot • Expiration date
• Expiration date
Mixed or partial GS1-128 barcode5 Information printed in ASAP but NLT June 30,
symbology encoded with: human readable format: 2022
• SSCC • SSCC
Secondary: trade item GS1 DataMatrix or GS1- Information printed in ASAP but NLT June 30,
128 barcode symbology human readable format: 2020
encoded with: • GTIN
• GTIN
And when applicable:
• Expiration date
Primary: Trade Item GS1 DataMatrix or GS1- Information printed in Optional
128 barcode symbology human readable format:
Optional; required only when the encoded with: • GTIN
product is supplied in carton-less • GTIN
packaging. And when applicable:
• Expiration date
4
5

SECTION NO. 4
DESCRIPTION OF PACKAGING LEVELS6

This section includes summary descriptions and examples of each level of the packaging hierarchy as it
relates to the GHSC-PSM implementation requirement. Levels are defined and should be referenced in
the GS1 General Specification.
TERTIARY PACKAGING
Tertiary packaging refers to upper levels of the packaging hierarchy. A tertiary pack may be:
• A pallet that contains (one or usually) several cases
• A case that contains (one or usually) several items in their primary or secondary packaging
Tertiary packaging may be used as either a logistic unit or as a trade item. Tertiary packages can be
homogenous (i.e., consisting entirely of the same trade item, batch/lot, and expiry), partial (i.e., consisting
of a homogenous pack of iems that is not to be considered a trade item because it is less than full) or mixed (i.e.,
either more than one unique trade item or entirely the same trade item with different batch numbers or
expiration dates).
Labels containing the barcode symbols, with their associated HRI, should be positioned on two faces of
the tertiary packaging to enable ready access for scanning when the product is stored, stocked on
shelves, or handled.
Logistic Unit
A logistic unit is an item of any composition established for transport and/or storage that needs to be
managed through the supply chain. In this instance, the tertiary package logistic unit refers to the logistic
units issued by the supplier to GHSC-PSM. In most instances, the tertiary package logistic unit will be
the pallet, but may also be an export carton.
The logistic unit is identified using the SSCC. This packaging level is marked with a GS1-128 linear
barcode.7
Trade Item
Trade items are products and services upon which there is a need to retrieve predefined information
and that may be priced, ordered, or invoiced at any point in the supply chain. The tertiary package trade
item will typically be a case or carton, but may also be a shrink-wrapped tray or other configuration.
A homogenous pack trade item is identified with a Global Trade Item Number (GTIN), batch/lot
number, expiration date, and serial number. A mixed or partial pack trade item is identified with an
6
For more information, see GS1 General Specifications – Section 8.1 GS1 Glossary of Terms and Definitions
7

SSCC. This packaging level can be marked with a GS1-128 linear barcode or a GS1 DataMatrix, with a
strong preference for a GS1 DataMatrix.
Examples of tertiary packaging include, but are not limited to:
SECONDARY PACKAGING
Secondary packaging is a level of packaging that may contain one or more primary packages, or a group
of primary packages containing a single item. This packaging level is marked with a GS1 DataMatrix,
either on the packaging or on a label affixed to the packaging.
Pharmaceutical products and medical devices can have more than one level of secondary packaging, such
as an inner pack (bundles) and intermediate packs (inner case). Identification and marking of inner
and intermediate secondary packaging levels are required for GHSC-PSM.

Examples of secondary packaging include, but are not limited to:

PRIMARY PACKAGING
Primary packaging is the first level of packaging that is in direct contact with the product. This packaging
level is marked with a GS1 DataMatrix, either on the packaging itself or on a label affixed to the
packaging.
Marking products at this level is optional, unless the supplier is providing items in “carton-less
packaging,” i.e., without a secondary packaging level.
Examples of primary packaging include, but are not limited to:

SECTION NO. 5
OVERVIEW OF GS1 STANDARDS USED

Current supply chain management practices in global health supply chains inhibit optimization of
information technology (IT) systems and drain supply chain business processes. GHSC-PSM is
committed to incorporating lessons learned over the last decade of global health supply chain
management and exploring industry innovations that will lead to a better, more efficient supply chain.
Adoption of global standards is a central part of that effort as a strategic enabler for supply chain
efficiency, effectiveness, and innovation for numerous industries across the globe. Therefore, to reduce
costs, enhance efficiency, and improve the availability of health commodities worldwide, GHSC-PSM is
committed to implementing and using the global standards detailed below to identify, capture, and share.
IDENTIFY
GHSC-PSM will leverage the GS1 Application Identifiers (AIs) referenced in this section for identifying
items and locations.
AI (00) Serial Shipping Container Code (SSCC)8

The GS1 AI (00) indicates that the data field contains an SSCC. The SSCC is used to uniquely identify a
logistic unit.
The SSCC must remain unique and not be reallocated for a minimum of one year from the shipment
date of the logistic unit from the SSCC assignor to the trading partner, in accordance with GS1 General
Specifications.
The SSCC format is as follows:
For more information on how to generate an SSCC and apply it to a logistics label, please refer to the
GS1 General Specification and the following resources:
• http://www.gs1.org/barcodes/technical/idkeys/sscca
• https://www.gs1.org/docs/tl/GS1_Logistic_Label_Guideline.pdf
AI (01) Global Trade Item Number® (GTIN®)9

The GS1 AI (01) indicates that the data field contains a GTIN. The GTIN is the globally unique GS1
identification number used to identify trade items (i.e., products that may be priced, ordered, or
8
For more information, see GS1 General Specifications, Section 3.3.1, Identification of a logistic unit (SSCC): AI (00)
9
For more information, see GS1 General Specifications, Section 3.3.2, Identification of a trade item (GTIN): AI (01)

invoiced). GTINs are assigned by the brand owner of the product and are used to identify products as
they move through the global supply chain to the hospital or ultimate end user.
The GTIN can be 8, 12, 13, or 14 digits in length. The format of the GTIN-14 is as follows:
For more information on how to generate and maintain a GTIN, please refer to the GS1 General
Specification and the following resources:
• http://www.gs1.org/gtin
• https://www.gs1.org/1/gtinrules/en/healthcare
AI (10) Batch/lot10
The GS1 AI (10) indicates that the data field contains a batch or lot number.
The format of the batch/lot number is as follows:
AI (17) Expiration date11

The GS1 AI (17) indicates that the data field contains an expiration date. The structure of the expiration
date should be as follows:
• Year: the tens and units of the year (e.g., 2003 = 03), which is mandatory
• Month: the number of the month (e.g., January = 01), which is mandatory
• Day: the number of the day of the relevant month (e.g., second day = 02); if it is not necessary
to specify the day, the field must be filled with two zeros
The format of the expiration date is as follows:
10
For more information, see GS1 General Specifications, Section 3.4.1, Batch or Lot Number: AI (10)
11
For more information, see GS1 General Specifications, Section 3.4.7, Expiration Date: AI (17)

AI (21) Serial number12
The GS1 AI (21) indicates that the data field contains a serial number. When combined with a GTIN, a
serial number uniquely identifies an individual item. The manufacturer determines the serial number.
The serial number field is alphanumeric. The character sequence resulting from the combination of the
GTIN and the serial number will be unique to a given pack of a medicinal product until at least one year
after the pack’s expiration date or five years after the pack has been released for sale or distribution,
whichever is the longer period.
The format of the serial number is as follows:
Global Location Number (GLN)13

The GLN is the GS1 standards-based, globally unique identifier for supply chain parties and locations. It
enables supply chain partners to use the same standards-based identifier to identify parties and locations
in a standardized data format. Supply chain partners use GLNs to identify parties and locations in all
supply chain transactions, supply chain communications, and internal systems.
GHSC-PSM does not require the GLN to be labeled on packaging, but will leverage GLNs in the data
exchange process. Chemonics’ GLN is 0858939007009 and will be used by the GHSC-PSM as the
identifier for AI (410) Bill to — Invoice to in procurement transactions.
GHSC-PSM expects suppliers to assign and provide GLNs for the following entities at a minimum:
• GLN for data sync

• AI (414) GLN for identification of a physical location, to be provided for the location a product
will ship from14
• AI (415) GLN of the invoicing party15
• AI (416) GLN of the production or service location16
12
For more information, see GS1 General Specifications, Section 3.5.2, Serial Number: AI (21)
13
For more information, see GS1 General Specifications, Section 4.6, GLN Rules
14
For more information, see GS1 General Specifications, Section 3.7.9, Identification of a physical location — Global Location Number: AI
(414)
15
For more information, see GS1 General Specifications, Section 3.7.10, Global Location Number of the invoicing party: AI (415)
16
For more information, see GS1 General Specifications, Section 3.7.11, GLN of the production or service location: AI (416)

For more information on how to generate and maintain a GTIN, please refer to the GS1 General
Specification and the following resources:
• https://www.gs1.org/gln
• https://www.gs1.org/docs/healthcare/GLN_Healthcare_Imp_Guide.pdf
CAPTURE
Per GHSC-PSM requirements, all tertiary and secondary packages should be labeled in accordance with
the specified barcode requirement, encoded with relevant GS1 Application Identifiers, and printed in
their human readable form.
All barcode symbols should meet print-quality “Grade C” (1.5 or above).17 As part of the regular
manufacturing/production process, barcode symbol print quality and data content must be verified and
graded in accordance with the appropriate sections within the GS1 General Specifications. Many GS1
Member Organizations (MOs) provide comprehensive barcode verification services to ensure
companies are implementing barcode labeling requirements to specification based on optical and data
structure requirements.
GS1-128 Barcode18
A GS1-128 barcode is linear barcode symbology using bars and spaces in one dimension that leverage a
subset of Code 128 that is used exclusively for GS1 system data structures. A linear barcode can be
concatenated (i.e., represent all elements of a data string in a single barcode) or non-concatenated (i.e.,
represent individual elements of a data string over two or more barcodes).
Example of a GS1-128 barcode for a tertiary package: logistic unit
Example of a GS1-128 barcode for a tertiary package: trade item
Concatenated (preferred)
17
For more information, see GS1 General Specifications — Section 5.5, Barcode Production and Quality Assessment.
18
For more information, see GS1 General Specifications, Section 5.4, Linear Barcodes — GS1-128 Symbology Specifications.

Non-concatenated (only if necessary)
GS1 DataMatrix19
A GS1 DataMatrix is a standalone, two-dimensional matrix symbology that is made up of square
modules arranged within a perimeter finder pattern. DataMatrix symbols are read by two-dimensional
imaging scanners or vision systems.
The GS1 DataMatrix is the preferred barcode symbology for trade items. If and when the GS1
DataMatrix is recommended for use on the logistic unit in the GS1 General Specification, suppliers are
permitted to use that data carrier to meet the GHSC-PSM logistic unit labeling requirement.
Example of a GS1 DataMatrix for a tertiary package — trade item or secondary package
19
For more information, see GS1 General Specifications, Section 5.7, Two-dimensional barcodes — GS1 DataMatrix symbology

SHARE
Master Data
GHSC-PSM has adopted and implemented the GS1 Global Data Synchronization NetworkTM ( GDSN®)
to receive item attribute information as the basis of our product catalog, and seeks the benefits of
synchronizing product data with trading partners for new and existing items. Using the GDSN process
will help improve supply chain data quality and management for all of our trading partners. It will provide
USAID-supported countries with the information they need to optimize decision-making for GHSC-PSM
order planning, procurement, shipping, and receiving. Master data received from synchronization will
allow countries to make the best purchasing decisions when ordering lif-saving commodities for global
health programs across the world.
All suppliers of pharmaceuticals, medical devices, sterile kits, and laboratory reagents are expected to
register with the GDSN and complete data sync with GHSC-PSM by December 30, 2019. The GHSC-
PSM Data Sync Implementation Guide and GHSC-PSM Data Attribute Guide (on our landing page at
www.1worldsync.com/customer-page/ghsc-psm) includes instructions for registering with a GDSN data
pool provider and initial priority attributes expected to be provided as relevant on products supplied to
GHSC-PSM.
Transaction Data
At the point when the supplier implements the product identification and labeling requirements, the
primary identification number on all transaction documentation provided to GHSC-PSM — including but
not limited to the packing list, commercial invoice, and advanced ship notice (ASN) — must reflect the
GTIN for the products included within. The packing list must also include SSCCs for logistic units once
applied to the logistic unit label.
Event Data
GHSC-PSM does not currently have a requirement to share event data.

SECTION NO. 6
IMPLEMENTATION PROCEDURES
To meet the GHSC-PSM requirement, all suppliers will be required to register their products and
locations with GS1. The following steps are illustrative and can be used as a guide based on experience
with other implementations.
REGISTER WITH A GS1 MEMBER ORGANIZATION TO OBTAIN A GS1 COMPANY

PREFIX
• Contact information for GS1 MOs can be found here: https://www.gs1.org/contact/overview
• More information on how to obtain a GS1 Company Prefix can be found here:
https://www.gs1.org/company-prefix
UNDERGO TRAINING AND EDUCATION

GS1 and certified solution providers can assist companies in training and education to support
implementation and compliance with the GHSC-PSM requirement.
ASSIGN GLOBALLY UNIQUE IDENTIFICATION NUMBERS TO ITEMS AND

LOCATIONS
Allocate a unique GTIN to each item and GLN to each business entity that transacts with GHSC-PSM.
For more information on how to generate and maintain GTINs and GLNs, please contact your GS1 MO
and refer to the to the GS1 General Specification. The following resources are also available:
• http://www.gs1.org/gtin
• https://www.gs1.org/gln
INTEGRATE PRODUCT AND LOCATION IDENTIFICATION INFORMATION INTO

INTERNAL SOFTWARE APPLICATIONS
Suppliers will have to capture the GTINs, GLNs, and other related attributes like name, description,
content, etc. in enterprise resource planning (ERP) applications or other internal software
applications. Parent-child relationships for product GTINs should be maintained in the database that
links the primary, secondary, and tertiary GTINs of each product and its variants.
IDENTIFY A GDSN-CERTIFIED DATA POOL AND SHARE PRODUCT MASTER DATA

WITH GHSC-PSM
A list of GDSN-certified data pool providers can be found on the GS1 website:
https://www.gs1.org/services/gdsn/certified-data-pools.
The GHSC-PSM Data Sync Implementation Guide and GHSC-PSM Data Attribute Guides include
instructions for registering with a GDSN data pool provider and initial priority attributes expected to be
provided as relevant for products supplied to GHSC-PSM. Those resources and additional information
can be found on GHSC-PSM’s GDSN landing page: www.1worldsync.com/customer-page/ghsc-psm

IMPLEMENT LABELING
Evaluate printing software and hardware
When choosing or using existing printer software, check the capability to properly format/encode, and
print GS1 symbol(s) in accordance with the coding and marking guidelines provided in this document
and the GS1 General Specifications.
The position of the barcode on the packaging will need to be checked to ensure that it meets the use
case and any requirements within the GS1 General Specifications.20 Any final labeling or wrapping should
also be examined to ensure that the barcodes remain visible and easy to scan.
Identify solution providers

For barcoding and printing solutions, companies can approach solution providers registered with GS1
for various barcoding, hardware/software, consumables, and other services. Details on solution
providers are available at https://www.gs1.org/spfinder.
20
For more information, see GS1 General Specifications, Section 6, Symbol Placement Guidelines.

SECTION NO. 7
RESOURCES
TRANSITION GUIDANCE
Until the supplier can comply with the trade item tertiary pack labeling requirement identified in
Sections 1 and 2 (except serialization), trade item tertiary packs must be labeled with the GHSC-PSM
stock-keeping unit (SKU), batch/lot, expiration date, and quantity in human readable form at a minimum.
Once a supplier is ready to transition to the new requirement, GTINs and relevant product master data
must be provided to GHSC-PSM through the GDSN, or the GHSC-PSM Product Master Form until the
point at which data synchronization through the GDSN is compulsory. Once GHSC-PSM confirms
receipt of the master data, shipments will be accepted with the GTIN labeling requirement.
GHSC-PSM RESOURCES
GHSC-PSM’s primary contact for global standards is:
Kaitlyn Roche
Manager, Global Standards
+1 (202) 558-5890
globalstandards@ghsc-psm.org
GHSC-PSM’s primary contact for master data synchronization is:
Samuel Oh
Product Catalog Manager
+1 (202) 558-5772
datasync@ghsc-psm.org
GS1 RESOURCES
A total 112 GS1 MOs are globally available to support registration, training and education, and
implementation. Information on how to contact GS1 is available here:
https://www.gs1.org/contact/overview
GDSN RESOURCES
A total 39 GSDN-certified data pools are available to support registration, training and education, and
implementation. Information on those organizations is available here: https://www.gs1.org/gdsn/certified-
data-pools. More information on syncing data with GHSC-PSM can be found on our GDSN landing page:
www.1worldsync.com/customer-page/ghsc-psm

ANNEX A: GLOSSARY OF TERMS
A glossary of key terms is provided below. GHSC-PSM recommends that suppliers consult the GS1
General Specification and use references and terms therein whenever available.
Term Definition
A technology used to automatically capture data. AIDC technologies

automatic identification and data
include barcodes, smart cards, biometrics and radio frequency
capture (AIDC)**
identification devices.
A symbol that encodes data into a machine-readable pattern of adjacent,

barcode*
varying width, parallel, rectangular dark bars and pale spaces.
The assessment of the printed quality of a barcode based on

International Standards Organization (ISO)/International
barcode verification*
Electrotechnical Commission (IEC) standards using ISO/IEC-compliant
bar code verifiers.
The batch or lot number associates an item with production

information that the manufacturer considers relevant for traceability of
batch/lot*
the trade item. The data may refer to the trade item itself or to items
contained in it.
The organization that owns the specifications of a trade item, regardless

brand owner* of where and by whom it is manufactured. The brand owner is normally
responsible for managing the GTIN.
A standalone, two-dimensional matrix symbology that is made up of

DataMatrix*
square modules arranged within a perimeter finder pattern.
The GS1 identification key used to identify trade items. The key
Global Trade Item Number
comprises a GS1 Company Prefix, an item reference, and check digit.
A neutral, not-for-profit, global organization that develops and maintains

GS1
the most widely used supply chain standards in the world.
A barcode symbology using bars and spaces in one dimension that

GS1-128 linear barcode leverages a subset of Code 128 that is used exclusively for GS1 system
data structures.
The field of two or more digits at the beginning of an element string

GS1 Application Identifier*
that uniquely defines its format and meaning.
*
GS1 AISBL. GS1 General Specification. Release 17.1, Ratified July 2017.

A globally unique string of four to twelve digits assigned to an entity and
used to issue GS1 identification keys. The first digits are a valid GS1
prefix and the length must be at least one longer than the length of the
GS1 Company Prefix* GS1 prefix. The GS1 Company Prefix is issued by a GS1 Member
Organization. As the GS1 Company Prefix varies in length, the issuance
of a GS1 Company Prefix excludes all longer strings that start with the
same digits from being issued as GS1 Company Prefixes.
GS1 DataMatrix* GS1 implementation specification for use of the DataMatrix.
A global, voluntary user group that develops standards to advance

global harmonization. GS1 Healthcare consists of manufacturers,
wholesalers, distributors, hospitals, and pharmacy retailers and
maintains close contacts with regulatory agencies and trade
GS1 Healthcare
organizations worldwide. It drives the development of GS1 standards
and solutions to meet the needs of the global healthcare industry and
promotes the effective use and implementation of global standards for
the industry.
A unique identifier for a class of objects (e.g., a trade item) or an

GS1 Identification Key*
instance of an object (e.g., a logistic unit).
A member of GS1 that is responsible for administering the GS1 system

in its country (or assigned area). This task includes, but is not restricted
to, ensuring user companies make correct use of the GS1 system; have
GS1 Member Organization*
access to education, training, promotion, and implementation support;
and have access to play an active role in the Global Standards
Management Process.
The first level of packaging for the product marked with an AIDC data
carrier either on the packaging or on a label affixed to the packaging.
For nonsterile packaging, the first level of packaging can be the
packaging in direct contact with the product. For sterile packaging, the
healthcare primary packaging* first level of packaging can be any combination of the sterile packaging
system and may consist of a single item or group of items for a single
therapy, such as a kit. For packaging configurations that include a retail
consumer trade item, primary packaging is a packaging level below the
retail consumer trade item.
A level of packaging marked with an AIDC carrier that may contain one
healthcare secondary packaging* or more primary packages or a group of primary packages containing a
single item.
Characters, such as letters and numbers, which can be read by persons

and are encoded in GS1 AIDC data carriers confined to a GS1 standard
structure and format. The human readable interpretation is a one-to-
human readable interpretation*
one illustration of the encoded data. However, start, stop, shift, and
function characters, as well as the symbol check character, are not
shown in the human readable interpretation.
An item of any composition established for transport and/or storage

logistic unit* that needs to be managed through the supply chain. It is identified with
an SSCC.

An entity that makes or produces drugs, pharmaceutical, or medical
manufacturer devices through a process involving raw materials, components, or
assemblies, usually on a large scale.
Any instrument, apparatus, implement, machine, appliance, implant, in

vitro reagent or calibrator, software, material or other similar or
medical device*
related article, intended by the manufacturer to be used, alone or in
combination, for human beings for any medical purpose.
A code, numeric or alphanumeric, assigned to an individual instance of

an entity for its lifetime. Example: microscope model AC-2 with serial
serial number* number 1234568 and microscope model AC-2 with serial number
1234569. A unique individual item may be identified with the combined
GTIN and serial number.
The GS1 identification key used to identify logistic units. The key
Serial Shipping Container Code
comprises an extension digit, GS1 Company Prefix, serial reference, and
(SSCC)*
check digit.
A vendor that provides technical or service support to a company. It

offers companies hardware, software, guidance, resources, and tools in
solution provider a variety of areas. Examples are barcode services, including labels,
printing, designing, and verifying; barcode hardware, including printers,
readers, and scanners; and barcode software.
An entity with which GHSC-PSM has a contractual relationship for

providing one or more trade items. The supplier is involved or plays a
supplier role in the buying, selling, or production of the pharmaceutical or
medical device and can be a manufacturer, brand owner, wholesaler, or
distributer.
A tertiary pack that consists entirely of the same trade item with the
tertiary homogenous pack
same batch number and expiration date.
A tertiary pack that contains either more than one unique trade item or
tertiary mixed pack entirely the same trade item with different batch numbers or expiration
dates.
The highest level of packaging that may include a pallet that contains
(one or usually) several cases or a case that contains (one or usually)
tertiary packaging
several items in its primary or secondary packaging. Tertiary packaging
may refer to either a logistic unit or a trade item.
A homogenous pack of products that is not to be considered a trade

tertiary partial pack
item because it is less than full.
Any item (product or service) upon which there is a need to retrieve

trade item* predefined information and that may be priced, or ordered, or invoiced
at any point in any supply chain.

ANNEX B: FREQUENTLY ASKED QUESTIONS
This document provides answers to frequently asked questions (FAQs) by the industry. It has been
created to aid trading partners across the global supply chain in applying GS1 Standards to GHSC-PSM
requirements.
The questions in this document are organized into four main sections:
• Section 1, IDENTIFY: Questions about GS1 identification numbers, including the identification of
trade items (products), logistic units, parties, and locations
• Section 2, CAPTURE: Questions about data carriers
• Section 3, SHARE: Questions about GS1 data sharing standards Global Data Synchronization
Network
• Section 4: Additional questions beyond the above three topics
SECTION 1: IDENTIFY
The questions in this section address identifying things — assigning a GS1 identification number to items
and locations so that it can be unambiguously referenced in data that is captured within an organization
and shared with other organizations.
1.1 Questions about the GTIN21

The questions in this section address identifying trade items (products) using the GTIN.
1.1.1 What is a GTIN?+

The GTIN is the globally unique GS1 identification number used to identify “trade items” (i.e.,
products and services that may be priced, ordered, or invoiced at any point in the supply chain).
It is assigned by the brand owner of the product and is used to identify products as they move
through the global supply chain to the hospital or consumer/patient. The GTIN is used to
uniquely identify a product at each packaging level (a bottle of 30 tablets, a case of 100 bottles of
tablets, etc.).
1.1.2 What happens when my case quantity changes? Do I need another GTIN?+
Yes. You need a new GTIN to identify a case containing a different number of trade items or to
identify a predefined pallet configuration containing a different quantity of cases.
1.1.3 How do I communicate my GTINs to GHSC-PSM?

GHSC-PSM is using the GDSN to receive master data from our trading partners. Additional
information on syncing data with GHSC-PSM can be found on our GDSN landing page:
http://www.1worldsync.com/customer-page/ghsc-psm
21
For more information, see GS1 General Specifications, Section 4.3, GTIN Rules
+
GS1 US. Frequently Asked Questions by the Pharmaceutical Industry in Preparing for the U.S. DSCSA. Release 1.0, May 23, 2017.

1.1.4 What is the difference between a GTIN and a serial number?
Each trade item is assigned a unique GTIN, but each instance of a given trade item receives a
different serial number. For example, a particular GTIN might be assigned to identify the trade
item “30-tablet bottle of drug XYZ.” All 30-tablet bottles of drug XYZ will have the same GTIN,
but each individual 30-tablet bottle of drug XYZ will have a different serial number.+ The unique
combination of GTIN and serial number can be used to track and trace that one individual
bottle through the supply chain.
1.1.5 What is the human readable interpretation?+

HRI is the printed representation of the data encoded in a barcode (e.g., GS1 DataMatrix or
GS1-128 barcode). HRI text always appears immediately adjacent to the barcode and is subject
to formatting rules specified in the GS1 General Specifications.22
A label may also repeat other information found in the barcode, such as the expiration date or
lot number, on some part of the label not near the barcode. Such printed information is not
considered HRI and is not subject to GS1 formatting rules (although other regulations governing
label content may apply).
1.2 Questions about the SSCC23

The questions in this section address identifying logistic units using the SSCC.
1.2.1 What is a Serial Shipping Container Code?+

The SSCC is the globally unique GS1 identification number used to identify individual logistic
units. A “logistic unit” is defined as an item of any composition established for transport and/or
storage that needs to be tracked individually and managed through the supply chain.
Common logistic units in the pharmaceutical industry include a pallet of cases picked to order, a
mixed case of items picked to order, or a homogeneous case of items that contains fewer than a
full case. Unlike a trade item, each logistic unit contains different contents.
1.2.2 What is an SSCC used for?+

The SSCC is assigned for the lifetime of the transport item and is a mandatory element on the
GS1 logistic label. SSCCs serve as “license plates” to facilitate simple tracking of goods and
reliable look-up of complex load detail. The SSCC enables the logistic unit to be tracked
individually, which brings benefits for order and delivery tracking and automated goods
receiving. Because the SSCC provides a unique number for the delivery, it can be used as a
lookup number to provide detailed information on load contents.
1.2.3 Who generates an SSCC?+

The shipping party creates the SSCC. When building a shipment for the buyer, the shipping
party creates an SSCC using the shipper’s GS1 Company Prefix (see Section 2.4) and places a
+
GS1
US. Frequently Asked Questions by the Pharmaceutical Industry in Preparing for the U.S. DSCSA. Release 1.0, May 23, 2017.
22
For more information, see GS1 General Specifications, Section 4.14 Human Readable Interpretation (HRI) Rules
23
For more information, see GS1 General Specifications, Section 4.4 SSCC Rules

logistics label containing the SSCC on the shipping unit (e.g., tote, pallet). Suppliers are
responsible for assigning (allocating) SSCCs to their logistic units.
1.2.4 Under which circumstances can an SSCC be reused?

When assigning an SSCC, the rule per the GS1 General Specification is that an individual SSCC
number must not be reallocated within one year of the shipment date from the SSCC assignor
to a trading partner.24
1.2.5 How is an SSCC different from a GTIN?+

SSCCs are distinctly different from GTINs. The SSCC acts as a license plate to track a shipment
of logistic units through the supply chain. The GTIN uniquely identifies trade items (products
and services).
1.2.6 My company already has a GS1 Company Prefix, which it uses to assign
GTINs. Does my company need another GS1 Company Prefix to use SSCCs?+
No. You can use the same GS1 Company Prefix that you already use for GTINs to create
SSCCs. If you have more than one GS1 Company Prefix, you can use any or all of them to
create SSCCs (and so you will have greater capacity than if you just had one GS1 Company
Prefix).
1.2.7 Can I use a SSCC when shipping partial homogeneous cases? What about
mixed cases?+
Yes to both. SSCCs should be used to identify partial cases of homogeneous items or mixed
cases of different items.
1.2.8 Can I have a GTIN and a SSCC together?

The GTIN and SSCC exist on the same package only when the package is both a logistic unit
and a trade item. When the GTIN and SSCC are labeled on the same package, they should be
captured in separate data carriers.
If a package is a trade item (e.g., an individual unit of use or a homogeneous case of fixed
composition), it will carry a GTIN; if a package is a logistic unit and/or a mixed or partial pack, it
will carry an SSCC.
An exception is a homogeneous case of fixed composition that is manufactured and marked

with serial number + GTIN, but later that case is shipped by itself and so is also a logistic unit for
the purpose of that shipment. In that scenario, the case must be given an SSCC as well, at the
point in the supply chain where it becomes a logistics unit. For purposes of data reporting, the
case serial number + GTIN would be considered as packed inside the logistic unit SSCC (that is,
the SSCC just has one serial number + GTIN as its contents), even though they are the same
physical package.
24
For more information, see GS1 General Specifications, Section 4.4.1.1, Allocating Serial Shipping Container Codes
+

The following table summarizes the identifiers present for GHSC-PSM compliance for
pharmaceuticals:
Identifier on Identifier on
Identifier on
Scenario tertiary pack tertiary pack
secondary pack
(trade item) (logistic unit)
Full homogeneous case where GTIN (based on the GTIN (based on the SSCC
there is a GTIN for that case item-level GTIN) + case-level GTIN) +
configuration, and the case is serial number serial number
packed onto a pallet with other
cases
Partial/incomplete homogeneous GTIN (based on the SSCC SSCC (different than
case, and the case is packed onto a item-level GTIN) + the case-level SSCC)
pallet with other cases serial number
Mixed case, and the case is packed GTIN (based on SSCC SSCC (different than
onto a pallet with other cases various item-level the case-level SSCC)
GTINs) + serial
number
Full homogeneous case where GTIN (based on the GTIN (based on the SSCC
there is a GTIN for that case item-level GTIN) + case-level GTIN) +
configuration, and the case is serial number serial number
shipped by itself as a logistic unit and SSCC
Partial/incomplete homogeneous GTIN (based on the SSCC
case, and the case is shipped by item-level GTIN) +
itself as a logistic unit serial number
Mixed case, and the case is shipped GTIN (based on SSCC
by itself as a logistic unit various item-level
GTINs) + serial
number
The following table summarizes the identifiers present for GHSC-PSM compliance for medical
devices, sterile kits, and laboratory reagents:
Identifier on Identifier on
Identifier on
Scenario tertiary pack tertiary pack
secondary pack
(trade item) (logistic unit)
Full homogeneous case where GTIN GTIN SSCC
there is a GTIN for that case
configuration, and the case is
packed onto a pallet with other
cases
Partial/incomplete homogeneous GTIN SSCC SSCC (different than
case, and the case is packed onto a the case-level SSCC)
pallet with other cases
Mixed case, and the case is packed GTIN SSCC SSCC (different than
onto a pallet with other cases the case-level SSCC)
Full homogeneous case where GTIN GTIN and SSCC SSCC
there is a GTIN for that case
configuration, and the case is
shipped by itself as a logistic unit
Partial/incomplete homogeneous GTIN SSCC
case, and the case is shipped by
itself as a logistic unit

Mixed case, and the case is shipped GTIN SSCC
by itself as a logistic unit
1.2.9 How do I pass SSCCs to GHSC-PSM?

In databases, SSCC fields should be 18 characters in length. The SSCC should be represented in
a database as a text field (not numeric), so that leading zeros are not inadvertently dropped.
Suppliers will provide SSCCs for all logistic units to GHSC-PSM on the packing list.
1.3 Questions about the GLN25

The questions in this section address identifying parties and locations using the GLN.
1.3.1 What is a GLN?+

The GLN is the globally unique GS1 identification number used to identify parties and locations.
The GLN can be used to identify a legal entity (like a brand owner), a functional entity (like a
manufacturing facility), or a physical location (like a warehouse, storage location, or clinic).
1.3.2 Who generates a GLN?+

The GLN for a legal entity is assigned by a GS1 Member Organization (MO) when the legal
entity first registers for a GS1 Company Prefix. For other GLNs, such as functional entities
within the legal entity or physical locations, the company that owns the functional entity or that
owns or occupies the physical location generates the GLN.
1.3.3 Do GLNs need to be encoded in a data carrier?

For the GHSC-PSM requirement, GLNs are not required to be labeled on packaging in a
barcode. The purpose of GLNs is to standardize location identification and related information
in master and transaction data exchange.
1.4 Questions about the GS1 Company Prefix26

The questions in this section address the GS1 Company Prefix.
1.4.1 What is a GS1 Company Prefix?+

A GS1 Company Prefix is a unique string of 6–11 digits issued to your company by your local
GS1 MO. These digits are part of every GS1 identification number that you create (GTIN,
SSCC, GLN, etc.). Because your GS1 Company Prefix is different from every other company’s
GS1 Company Prefix worldwide, the GS1 identification numbers you create are also globally
unique.
1.4.2 Does the GS1 Company Prefix uniquely identify my company or brand?+
No. The GS1 Company Prefix is not an identifier. It is a string of digits that is used as a part of
GS1 identification numbers. A GS1 Company Prefix does not uniquely identify a company or
brand because a given company could have more than one GS1 Company Prefix, and sometimes
25
For more information, see GS1 General Specifications, Section 4.6, GLN Rules
+
26
For more information, see GS1 General Specifications, Section 1.5, GS1 Company Prefix Allocation

a company uses the same GS1 Company Prefix to identify products of several brands. The
unique identifier for a company is a corporate GLN.
1.4.3 How do I get a GS1 Company Prefix?

To get a GS1 Company Prefix, suppliers must register with a GS1 MO. Contact information for
GS1 MOs globally can be found here: https://www.gs1.org/contact/overview. More information
on how to obtain a GS1 Company Prefix can be found here: https://www.gs1.org/company-
prefix.
1.4.4 Our company does business in multiple countries. Do I need a GS1 Company
Prefix for each country?+
No. Your GS1 Company Prefix can be used to create GTINs, SSCCs, GLNs, or any other GS1
identification number for use globally. You are encouraged to license your GS1 Company Prefix
with the country where you are headquartered and where you will look to receive GS1
support.
1.4.5 If an intermediary supplier (e.g., wholesaler, distributer) is supplying

pharmaceuticals or medical devices to GHSC-PSM, then whose GS1 Company
Prefix should be used for identification on the GTIN, GLN, and SSCC?
Ideally, the GS1 Company Prefix registered to the brand owner of the product should be
used. If the brand owner does not provide its GS1 Company Prefix, then either the actual
manufacturer or supplier has to identify the drugs using a GS1 Company Prefix registered to
them to comply with the requirements
SECTION 2: CAPTURE
The questions in this section address capturing data from physical items using barcode data
carriers. GS1 data carriers provide machine-readable representations of GS1 identification keys that
facilitate automatic identification and data capture.
2.1 Questions about GS1-128 barcode data carriers27

The questions in this section address the GS1-128 barcode data carrier. For more information, please
see the GS1 General Specification.
2.1.1 What is a GS1-128 barcode?+

GS1-128 is a linear barcode used to encode data for logistic units such as cases and pallets.
Using this barcode supports fast and accurate data capture and inventory tracking, adding
visibility to your supply chain.
The GS1-128 barcode is most commonly used to label a logistic unit with a SSCC.
2.2 Questions about GS1 DataMatrix data carriers28
+
27
For more information, see GS1 General Specifications, Section 5.4, GS1-128 symbology specifications
28
For more information, see GS1 General Specifications, Section 5.7, Two-dimensional barcodes — GS1 DataMatrix symology

The questions in this section address the GS1 DataMatrix data carrier. For more information, please see
the GS1 General Specification.
2.2.1 What is a GS1 DataMatrix? +

The GS1 DataMatrix is a two-dimensional barcode that may be printed as a square or
rectangular symbol made up of individual squares. This representation is an ordered grid of dark
and light squares bordered by a finder pattern. The finder pattern is partly used to specify the
orientation and structure of the symbol. The data is encoded using a series of dark or light
squares based on a predetermined size. The size of these squares is known as the X-dimension.
The GS1 DataMatrix is most commonly used to label a trade item with a GTIN and other
related information, such as batch/lot, expiration date, and serial number.
2.2.2 What is a QR Code, and how is it different from a GS1 DataMatrix?+

A QR Code is a two-dimensional matrix symbology consisting of square modules arranged in a
square pattern. The symbology is characterized by a unique finder pattern located at three
corners of the symbol. QR Code version 2005 is the only version that supports GS1
identification numbers, including function 1 symbol character. QR Code symbols are read by
two-dimensional imaging scanners or vision systems.
2.2.3 What is the physical difference between a GS1 DataMatrix and a QR Code?+
GS1 DataMatrix and QR Codes can be distinguished by the naked eye by looking at the finder
patterns. A GS1 DataMatrix will appear to have a solid black line on two sides of the symbol. A
QR Code has a distinctive square “bulls-eye” pattern in three of the four corners.
2.2.4 Why are QR codes not being used by GHSC-PSM?

QR Codes are not recommended for use in regulated healthcare environments. For more
information, please refer to the GS1 Healthcare discussion paper on the use of GS1 DataMatrix in
Healthcare and a comparison to the GS1 QR Code.29
2.3 General questions about data carriers

The questions in this section address general information on data carriers. For more information, please
see the GS1 General Specification.
2.3.1 What are GS1 Application Identifiers?30 How are AIs manifested in the
barcode and/or human readable information?+
GS1 AIs are used in barcodes that are capable of holding more than one data element, such as
the GS1 DataMatrix. In such barcodes, each data element is prefixed with a GS1 AIto. indicating
the meaning of that data element. Each AI is a two-, three-, or four-digit numeric code. When
rendered in human readable form, the AI is usually shown in parentheses. However, the
parentheses are not part of the barcode-encoded data.
+
29
https://www.gs1.org/sites/default/files/docs/healthcare/GS1%20QR%20DM%20discussion%20paper_20140113_FINAL.pdf
30
For more information, see GS1 General Specifications, Section 3, GS1 Application Identifier definitions

For example, the AI for GTIN is 01. Thus, when “01” appears in the encoded content of a
barcode that uses AIs, it means the next 14 digits are a GTIN. The AI for serial number is 21.
Thus, when “21” appears in the barcode, it means that the next characters are a serial number.
The combination of a single AI and the following data is called a “GS1 element string.” A series
of GS1 element strings in a single barcode is called a “concatenated element string.”
2.3.2 How are AIs used in a data carrier?

Each GS1 identification number (GTIN, SSCC, etc.) has an AI. Also, there are AIs for various
types of secondary information to enable supply chain partners to communicate item-specific
information wherever the barcode is scanned (expiration date, lot number, batch number, etc.).+
The following table lists the AIs that are relevant for GHSC-PSM.
Typical Characters following
Use case Data element AI
barcode type the AI
GTIN 01 14 digits
Expiration date 17 6 digits

Trade item GS1 DataMatrix 1–20 alphanumeric
Batch/lot number 10
characters
1–20 alphanumeric
Serial number 21
characters
Logistic unit GS1-128 SSCC 00 18 digits
2.3.3 Is there a specific order in which AIs must be encoded in the barcode?
No. AIs may be encoded in any order. However, for the most efficient encoding, it is best to
have fixed-length data elements precede variable-length elements. As an example:
• (01) GTIN
• (17) Expiration date
• (10) Batch
• (21) Serial number
Systems that read barcodes must not rely on AIs being arranged in any particular order. They
must be prepared to process the data regardless of the ordering of AIs.
2.3.4 Can additional AIs be encoded in the barcode, other than those specified by
GHSC-PSM?
The GHSC-PSM requirement identifies the minimum GS1 identification keys to be included on
product labels. However, additional AIs are permitted at the discretion of the supplier,
particularly in producing multimarket packs.
+

While barcode reading applications should work correctly even if additional AIs are present, the
use of additional AIs is discouraged to avoid possible problems if downstream barcode reading
applications are not implemented correctly.
2.3.5 How do I know if my barcode is correct?+

Many GS1 MOs and other companies provide fee-based barcode verification
services. Verification services typically work like this:
• You submit samples of your barcoded item(s) in their final packaged form. If you are
submitting a barcode that is located directly on an irregularly shaped unit, the item in its
entirety is needed for review. Artwork samples (e.g., laser prints, bromides, mock-ups,
and proofs) can be tested to provide an interim report on barcode size and quiet zones.
However, final samples of actual packaging are needed to provide a complete
verification report.
• Your solution provider will test your barcode(s) for compliance with GS1 Standards
using a formal verification process. Testing assesses size, color, print quality, quiet zones,
barcode height, location/placement, and calculation of the check digit.
• Your solution provider will deliver a detailed report showing how your barcode(s)
performed.
SECTION 3: SHARE
The questions in this section address sharing data between trading partners using GS1 data-sharing
standards.
3.1 Questions about master data

These questions provide descriptive information about GS1 identification numbers, such as GTINs
and GLNs.
3.1.1 What is master data?

Master data is description attribute information about a product (GTIN) or location (GLN).
Examples of product master data include weight, dimensions, shelf-life, and quantity. Examples
of location master data include delivery points/addresses, individual locations of an entity (e.g.,
manufacturing facility, warehouse, headquarters), contact information, or bank account
information.
3.1.2 What is the GS1 standard for sharing master data?

The GS1 standard for sharing master data for trade items is called the GDSN. GS1 does not
currently have a standard for sharing master data for parties or locations.
3.1.3 What is the GDSN?

The GDSN is an automated, standards-based global environment that enables secure and
continuous data synchronization of product information. This allows all trading partners to have
consistent item data in their systems at the same time, ensuring that all parties in the supply
chain are working with the same data. The GDSN helps to save time and money for all
organizations by eliminating steps to correct inaccurate data. The GDSN is comprised of the
GS1 Global Registry® and a network of interoperable, certified data pools that enable data
synchronization aligned with the GS1 system of standards.
More information on the GDSN can be found here: https://www.gs1.org/gdsn

3.1.4 What is data synchronization?
Data synchronization is the electronic transfer of product information between trading partners
and the continuous synchronization of that data over time. The GS1 GDSN is a synchronization
method for GS1-standards based data that is exchanged through a central global repository
known as the GS1 Global Registry®. The registry serves a “traffic director” in the publication
and subscription process. It is not a database that an individual or entity can access directly
outside of the data sync process.
Product information is referred to as “attributes” in the GDSN. Attributes are defined by the
supplier (e.g., GTIN, size, weight, height, brand). More than 3,000 item attributes are available in
the GDSN.
3.1.5 Why is GHSC-PSM implementing data synchronization?

GHSC-PSM will be using the GDSN to receive item information as the basis of our product
catalog. This will enable GHSC-PSM to provide USAID-supported countries with the
information they need to optimize decision-making around order planning, procurement,
shipping, and receiving through GHSC-PSM for better data visibility and improved data quality.
Synchronized data will allow countries to make the best purchasing decisions when ordering life-
saving commodities for health programs across the globe.
3.1.6 What are the benefits of syncing data through the GDSN?
Data synchronization offers several benefits, including:
• Reduces data errors between trading partners
• Allows for real-time item attribute maintenance and updates
• Ensures logistics information, including size, dimensions, and weight, is accurate and
received at the each, case, warehouse pack, and pallet levels
• Provides accurate, standards-based, synchronized data that reduces supply chain
inefficiencies
• Enables accurate data exchange from many data sources to many recipient parties with a
single entry
3.1.7 What is a data pool? What is a GDSN-certified data pool?

A data pool is an entity that provides data synchronization services and a single point of entry to
the GDSN. Data pools must be certified by GS1 to operate within the GDSN. Data pools
interoperate with the GS1 Global Registryand each other. 1WorldSync is an example of a
GDSN-certified data pool.
For questions on how to choose the right data pool for your organization, please refer to the
GS1 website: https://www.gs1.org/gdsn
3.1.8 Where can I find a list of GDSN-certified data pools?

The GS1 website has a list of GDSN-certified data pools with contact information, which can be
found here: http://www.gs1.org/gdsn/certified-data-pools
3.1.9 Who is 1WorldSync?

1WorldSync is a GDSN-certified data pool and works closely with GHSC-PSM in implementing
its data synchronization initiative. A subsidiary of GS1 US and GS1 Germany, 1WorldSync
supports and works with more than 16,000 companies of all sizes. GHSC-PSM uses the
1WorldSync Data Pool Solution for its GDSN services.

To learn more about 1WorldSync and its services:
• Visit http://www.1worldsync.com/
• Call +1 (866) 280-4013, Option 1
3.1.10 Do I have to sign up with 1WorldSync?

You need to select a GDSN-certified data pool to synchronize your company’s data through the
GDSN. GHSC-PSM uses 1WorldSync as a GDSN-certified data pool, but your company can
choose any of the GDSN-certified data pools for synchronization.
The GS1 website has a list of GDSN-certified data pools with contact information, which can be
found here: http://www.gs1.org/gdsn/certified-data-pools
3.1.11 Where do I start?

The steps to get started are:
• Visit the GHSC-PSM GDSN landing page at www.1worldsync.com/customer-page/ghsc-
psm
• Complete the GHSC-PSM Trading Partner Form.
• Review the GHSC-PSM Data Synchronization Implementation Guide, which will walk
you through the implementation process.
• Review the GHSC-PSM Attribute Guide, which will inform you of the data GHSC-PSM
seeks to collect through the GDSN.
3.2 Questions about transaction data

The questions in this section address the GS1 standard for sharing transaction data with GHSC-PSM.
3.3.1 What is transaction data?

Transaction data is information about production, purchasing, selling, and other transactions
that occur through the supply chain.
3.3.2 What is the GS1 standard for sharing transaction data?

The GS1 standard for sharing transaction data is electronic data onterchange (EDI). The EDI
standards promoted by the GS1 system (i.e., EANCOM, GS1 XML) make full use of GLNs to
simplify business messaging automation.
3.3.3 What is EDI?

EDI is a form of peer-to-peer data exchange in a standard electronic format between business
partners. EDI allows information that has traditionally been exchanged by paper, for example,
purchase orders and invoices, to be communicated electronically instead through a standard
format.
3.3.4. Will GHSC-PSM use EDI for the exchange of transaction data?
GHSC-PSM is evaluating the use of EDI for transaction data exchange with suppliers, and
additional information will be provided once requirements have been developed. In the interim,
if a supplier is interested in piloting EDI for transaction data exchange with GHSC-PSM, please
email globalstandards@ghsc-psm.org.
3.3 Questions about event data

The questions in this section address the GS1 standard for sharing visibility event data. This section is
informational; currently, GHSC-PSM does not have a requirement to share visibility event data.

3.3.1 What is event data?
Event data is information about the physical movement and status of products as they move
through the supply chain.
3.3.2 What is the GS1 standard for sharing event data?

The GS1 standard for sharing transaction data is Electronic Product Code Information Services
(EPCIS). EPCIS is intended to be used in conjunction with the GS1 Core Business Vocabulary
(CBV) standard.
3.3.3 What is the EPCIS standard?+

This standard defines a data model and a data-sharing interface that enables supply chain
partners to capture and communicate data about the movement and status of objects in the
supply chain. EPCIS breaks down supply chain business processes into individual steps, such as
commissioning, packing, shipping, and receiving, and provides a standard language in which a
party carrying out one of these steps can communicate the essential business information about
that step to trading partners who need to know the what, when, where, and why of each step.
Each such step is called an “event,” and the term “EPCIS event” refers to the data record that
describes an event using the standard EPCIS language.
3.3.4 Will GHSC-PSM use EPCIS for exchange of event data?

GHSC-PSM is assessing our processes and systems, in addition to those in the countries we
support, to determine the appropriateness and applicability of leveraging EPCIS in our supply
chain in the future.
SECTION 4: ADDITIONAL QUESTIONS

4.1 Questions about the GHSC-PSM requirement
The questions in this section address the GHSC-PSM requirement.
4.1.1 For which products does the GHSC-PSM requirement apply?

GHSC-PSM has a requirement for pharmaceuticals, medical devices, laboratory reagents, and
sterile kits. Identification and labeling in adherence to this requirement are optional for other
products at this time.
4.1.2 Does GHSC-PSM require a transition period to the new requirement?

No. The previous labeling requirement, using the GHSC-PSM SKU on the logistic unit, is used
only in the GHSC-PSM regional distribution centers for logistics and inventory control. GHSC-
PSM’s systems were developed to use the GTIN as the primary identifier, the only dependency
being availability of master data associated with the GTIN for implementation.
4.1.3 Are there circumstances in which suppliers can request an exemption from
the requirement?
+

No. Suppliers of products referenced in 4.1.1 will not be exempted from the GHSC-PSM
requirement.
4.1.4 Are there circumstances in which suppliers can request an exception from the
requirement?
Exceptions to adherence will not be granted for product identification. All suppliers are
expected to obtain a GS1 Company Prefix and assign GTINs to items and GLNs to parties or
locations.
Exceptions for adherence will be considered on a case-by-case basis ONLY for the labeling
and master data exchange requirement, when the supplier can demonstrate a reasonable
effort to implement within the required timeframe.
To request an exception to the GHSC-PSM requirement, please email globalstandards@ghsc-

psm.org.
4.2 Questions about GHSC-PSM-supported country programs

The questions in this section address the applicability of the GHSC-PSM requirement to supported
country programs.
4.2.1 Which guidelines need to be adhered to in the case that the importing country
has specific requirements?
If the importing country regulatory authority has mandated its own specific requirements for
barcoding, the supplier need not comply with the GHSC-PSM requirements for identifying and
labeling various levels of packaging. However, an instance in which the GHSC-PSM requirement
will not be applied needs to be confirmed with GHSC-PSM and relevant authorities.
4.2.2. Is GHSC-PSM supporting countries to leverage the standardized barcodes in

their supply chains?
Yes. GHSC-PSM has issued guidance to country programs to implement GS1 global standards
within their supply chains. GHSC-PSM is providing technical assistance to select countries to
support regulatory, procurement, supply chain operations, and systems deployment activities as
they relate to global standards and in support of verification or track-and-trace initiatives.

U.S. Agency for International Development
1300 Pennsylvania Avenue, NW
Washington, D.C. 20523
Tel.: (202) 712-0000
Fax: (202) 216-3524
www.usaid.gov

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What products does the GHSC-PSM requirement apply to?

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Can suppliers request exemptions from the GHSC-PSM requirement?

USAID GLOBAL HEALTH SUPPLY CHAIN PROGRAM

PR O CURE ME NT AND S UPPLY MANAGEMENT

GLOBAL STANDARDS TECHNICAL

Version 1.0, January 2018

Version 1.0, January 2018

REVISION HISTORY ....................................................................................................................... 3

OVERVIEW OF THE REQUIREMENT FOR PHARMACEUTICALS ........................................ 6

OVERVIEW OF THE REQUIREMENT FOR MEDICAL DEVICES, STERILE KITS, AND

DESCRIPTION OF PACKAGING LEVELS ................................................................................... 8

ANNEX B: FREQUENTLY ASKED QUESTIONS ...................................................................... 24

Global Standards Technical Implementation Guide | i

GHSC-PSM Global Standards Technical Implementation Guide | 2

Date Version no. Description of change Author

Jan 1, 2018 1.0 Initial document K. Roche

GHSC-PSM Global Standards Technical Implementation Guide | 3

USAID TECHNICAL DIRECTION

ABOUT THE GHSC-PSM REQUIREMENT

GHSC-PSM Global Standards Technical Implementation Guide | 4

In addition to the identification and labeling requirements outlined in the specifications,

ABOUT THIS DOCUMENT

GHSC-PSM Global Standards Technical Implementation Guide | 5

OVERVIEW OF THE REQUIREMENT FOR

Packaging Packaging Human readable

Tertiary: logistic unit GS1-128 barcode2 Information printed in As soon as possible

GHSC-PSM Global Standards Technical Implementation Guide | 6

OVERVIEW OF THE REQUIREMENT FOR

GHSC-PSM Global Standards Technical Implementation Guide | 7

DESCRIPTION OF PACKAGING LEVELS6

GHSC-PSM Global Standards Technical Implementation Guide | 8

Examples of tertiary packaging include, but are not limited to:

GHSC-PSM Global Standards Technical Implementation Guide | 9

GHSC-PSM Global Standards Technical Implementation Guide | 10

Examples of primary packaging include, but are not limited to:

GHSC-PSM Global Standards Technical Implementation Guide | 11

OVERVIEW OF GS1 STANDARDS USED

AI (00) Serial Shipping Container Code (SSCC)8

The SSCC format is as follows:

AI (01) Global Trade Item Number® (GTIN®)9

GHSC-PSM Global Standards Technical Implementation Guide | 12

The format of the batch/lot number is as follows:

AI (17) Expiration date11

The format of the expiration date is as follows:

GHSC-PSM Global Standards Technical Implementation Guide | 13

The format of the serial number is as follows:

Global Location Number (GLN)13

• GLN for data sync

GHSC-PSM Global Standards Technical Implementation Guide | 14

Example of a GS1-128 barcode for a tertiary package: logistic unit

Example of a GS1-128 barcode for a tertiary package: trade item

GHSC-PSM Global Standards Technical Implementation Guide | 15

GHSC-PSM Global Standards Technical Implementation Guide | 16

GHSC-PSM Global Standards Technical Implementation Guide | 17

REGISTER WITH A GS1 MEMBER ORGANIZATION TO OBTAIN A GS1 COMPANY

UNDERGO TRAINING AND EDUCATION

ASSIGN GLOBALLY UNIQUE IDENTIFICATION NUMBERS TO ITEMS AND

INTEGRATE PRODUCT AND LOCATION IDENTIFICATION INFORMATION INTO