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Document Sample
EPCglobal HLS Industry Adoption
Roadmap
Final Version v13.2
Prepared by the EPCglobal HLS Industry Adoption
Task Force
For General Release
Published ___, 2008
A Message from the Co-Chairs
• We are proud to have served on this important initiative, and honored to have been
chosen as leads for the effort.
• Many people gave selflessly of their time and talent to create this document.
• We wish to express heartfelt thanks to the EPCglobal HLS Tri-Chairs, Ron Bone, Mike
Rose, and Ramesh Murthy for their unwavering support, advice, counsel, and friendship
during the course of this project!
• We owe a debt of gratitude to the EPCglobal staff, particularly Chuck Schramek for his
leadership in guiding us through the entire process, providing his excellent facilitation
skills, and bringing humor and fellowship to the project.
• A special thank you to Bob Celeste as well, for his untiring efforts in promoting our efforts,
helping us through the tough times, and generally just ‗being there‘ for us.
• And finally, a big thank you to our good friends at GS1: Ulrike Kreysa, Michel van der
Heijden, Bernie Hogan, John Terwilliger and John Roberts for always making time to
provide expert advice on GS1 standards and philosophy. Their contributions are evident
throughout the document.
• We hope that you will find this information enlightening and useful in your efforts to design
Serialization and Pedigree solutions for your companies.
Best Regards and Happy Reading!
Ted Ng, McKesson Corporation
Grant Hodgkins, Alcon Laboratories
Slide 2
EPCglobal Confidential and Proprietary
IATF Companies / Organizations
The following organizations participated in creation of this deliverable.
Supply Chain Partners Supply Chain Partners Trade / Regulatory
•Abbott Laboratories •Kimberly-Clark •Auto-ID Labs (MIT)
•Ahold N.V. •Matsushita Electric •CPhA
•Albertsons •McKesson Corporation •EPCglobal HLS Community
•Alcon Laboratories •Merck & Co. •FDA
•Allergan •MetaBiz
•AmerisourceBergen Corp. •Motorola Inc. •GS1 HUG Community
•AstraZeneca •NEC Corporation •HDMA
•Baxter Healthcare Corp. •Nestle S.A. •NACDS
•Bristol Meyers Squibb •Pfizer Inc. •NCPA
•Cardinal Health •Proctor & Gamble
•CVS •Royal Philips Electronics N.V.
•Dai Nippon Printing •Target
•Genzyme Corporation •The Dow Chemical Company
•GlaxoSmithKline •Unisys
•Johnson & Johnson •Upsher-Smith Labs
•Ken Traub Consulting LLC •Walgreens Company
Slide 3
EPCglobal Confidential and Proprietary
Table of Contents—HLS Roadmap
Executive Summary
1. Purpose
2. Scope
3. Capabilities and Suggestions
a. Unique Identification
b. Pedigree
4. Action Steps
5. Summary and Recommendations
6. Appendices
Communications Plan (Separate Deliverable)
Slide 4
EPCglobal Confidential and Proprietary
Notes to Reader
• Although this is an EPCglobal chartered team, this document
provides flexibility in selecting an appropriate data carrier. Barcodes
and RFID are both represented within the document.
• This document is a point-in-time snapshot of the current thinking of
the EPCglobal HLS Industry Adoption Task Force.
• It is intended as a starting point for the various industry trade
associations. See Appendix 5 for a list of associations who
commented on the document.
• Once the document is handed-off these industry trade associations,
this document may no longer be kept current.
• Work through your industry trade association to obtain the latest
information regarding industry adoption activities and materials for
your market segment.
Slide 5
EPCglobal Confidential and Proprietary
Disclaimer
• Supply chain participants should rely upon their
companies‘ legal interpretations of regulatory
requirements.
– The Industry Adoption Task Force does not interpret legislation
nor recommend compliance postures.
– Suggestions presented in the Roadmap and associated
documents are designed to provide a starting point for industry
collaboration towards common solutions.
– Suggestions and/or other team deliverables are not to be
considered as legal advice and are not intended to substitute for
competent legal counsel.
Slide 6
EPCglobal Confidential and Proprietary
Executive Summary
• Mission:
– Define a ‗starting set‘ of suggestions for industry trade
associations to discuss with their members to facilitate their
efforts in addressing current and emerging regulatory
requirements for improving supply chain safety and security.
– Work closely with EPCglobal and GS1 HUG (Healthcare User
Group) to develop consensus-based suggestions.
– Educate and hand-off the Roadmap and other deliverables to
industry trade associations.
• NOTE: Not intended to be the „final answer‟ for the industry—
the Roadmap is only a starting point for more widespread
debate and discussion within the various industry trade
associations.
Slide 7
EPCglobal Confidential and Proprietary
Executive Summary
• Deliverables:
– HLS Industry Adoption Roadmap
• Capabilities
• Suggestions
• Action Steps
• Issues / Barriers / Assumptions
• Rationale / Pro and Con Assessment
– Communications Plan / Strategy
• Outreach Message
• Groups to target for feedback
• Feedback mechanism and process
• Process to hand-off to industry trade associations
Slide 8
EPCglobal Confidential and Proprietary
Purpose of the Roadmap
Slide 9
EPCglobal Confidential and Proprietary
Purpose of The Roadmap
• The Roadmap provides suggestions in meeting current and
emerging regulatory expectations, including the direction
outlined by the FDA‘s “Counterfeit Drug Task Force Report:
2006 Update”, the California Pedigree Law (SB1476), and
Federal PDMA law.
– Pedigree and Unique Identification, deployed in a coordinated manner, are two
Key Capabilities which can advance the industry towards improvements in the
safety and security of the supply chain.
• Serves as a starting point for broader discussions within the
context of industry trade associations.
• Documents the best ideas from the Industry Adoption Task
Force, composed of a cross-section of knowledgeable
industry representatives.
• Describes the thought process and rationale of the Industry
Adoption Task Force in arriving at the various suggested
elements.
Slide 10
EPCglobal Confidential and Proprietary
Purpose of The Roadmap
• The Health and Life Sciences (HLS) industry shares the
vision of a ‗safe and secure drug supply chain‘ premised on
transparency and accountability by all persons who handle
the prescription drug, starting with the manufacturer and
ending with the pharmacy or other healthcare points of
dispense, including both forward- and reverse-logistics
transactions.
– Simply issuing a Pedigree or Uniquely Identifying a product alone does
not improve safety nor security. The ―coordinated exchange‖ of
uniquely identified products using the concept of pedigree transactions
can result in improved supply chain safety and security.
– The Roadmap is constructed to balance the perceived risks and
benefits. This balancing is needed to lessen the impact of incremental
costs on the continued availability of affordable healthcare while still
achieving the goal of ‗a safe and secure supply chain‘.
Slide 11
EPCglobal Confidential and Proprietary
Scope of the Roadmap
Slide 12
EPCglobal Confidential and Proprietary
Scope of The Roadmap
• Addresses two Key Capabilities:
– Unique Identification, including,
• Serialization
• Data Carriers for Serialization
– RFID
– Barcodes
– Pedigree, which includes the secure exchange of product
transactional information between trading partners using an
interoperable electronic system.
• Presents Suggestions, Action Steps, and
Issues/Barriers and Assumptions as a starting point for
industry trade associations.
Slide 13
EPCglobal Confidential and Proprietary
Scope of The Roadmap
• Applies to HLS supply chains and participants.
– Focus on US Rx drug supply chains and products:
• Most urgent compliance requirements and dates.
• California represents the most stringent set of requirements.
– Designed with flexibility to address other HLS products and
geographic regions as future requirements arise.
– Adapts and leverages existing GS1 and EPCglobal standards
and guidance from HDMA publications.
– A comprehensive list of key sources is included in the Appendix.
Slide 14
EPCglobal Confidential and Proprietary
Assess Impact on Trading Partners
Introduction to This Section
• As choices of data carrier, serialization scheme, pedigree
and other decisions are made, those choices will necessarily
impact your trading partners.
• The following slides highlight some of the concerns,
organized by industry segment, that should be considered as
you develop strategy and plans.
• This section provides only a basic awareness and a starting
point for trading partner discussions.
• Benefits can be more easily captured by all supply chain
participants if all segments work closely together to
understand and address each others‘ concerns.
Slide 15
EPCglobal Confidential and Proprietary
Assess Impact on Trading Partners
Manufacturer Concerns with Options and Choices
• Cost and time to implement serialization, regardless of data
carrier, presents challenges to wide-scale deployment on all
products and all packaging levels.
• Variety of special-situation supply chains present unique
challenges (cold chain, reverse logistics, vaccines, liquids,
biologics, contract manufacturing, etc.)
• Difficult to justify expenditures for serialization and pedigree
unless it is clear that most or all trading partners will utilize
this new technology.
• Contract manufacturing supply chains may introduce some of
the same concerns from the following Wholesaler and
Retailer slides into the Manufacturer‘s operations.
Slide 16
EPCglobal Confidential and Proprietary
Assess Impact on Trading Partners
Wholesaler Concerns with Options and Choices
• Supporting multiple data carriers will multiply the costs and
complexities for the wholesalers.
• In the absence of Serialized Inference, data carriers requiring line-
of-sight used at lower packaging levels will significantly decrease
productivity.
• Mixture of pedigreed/serialized products and non-pedigreed/non-
serialized products complicates operations.
• Must have knowledge of the serialized hierarchy prior to receipt, for
instance via an Rx ASN.
• Trading partners may choose to build the serialized hierarchy
and/or the pedigree in different formats, complicating operations.
• Potential for throughput and inventory issues based on the
combination of the above factors.
Slide 17
EPCglobal Confidential and Proprietary
Assess Impact on Trading Partners
Retailer Concerns with Options and Choices
• Each choice of data carrier has its own cost-benefit implications not only for a
specific company, but also for those trading partners further down the supply
chain.
• Supporting multiple data carriers will multiply the costs and complexities for the
retail pharmacies in particular.
• In the absence of Serialized Inference, data carriers requiring line-of-sight used
at lower packaging levels will significantly decrease the productivity of retail
distribution centers and pharmacies.
• Must have knowledge of the serialized hierarchy prior to receipt, for instance
via an Rx ASN.
• Trading partners may choose to build the serialized hierarchy and/or the
pedigree in different formats, complicating operations.
• Potential for throughput and inventory issues based on the combination of the
above factors.
• There is a compelling need for a total supply chain impact assessment
comparing the costs and benefits of the current options for choice of data
carrier, particularly at the item level.
Slide 18
EPCglobal Confidential and Proprietary
Capabilities and Suggestions
Slide 19
EPCglobal Confidential and Proprietary
Capability and Suggestions
Capability and Suggestion slides formatted as:
Capability
– Identifies the capabilities needed by trading partners to address
regulatory or other requirements.
Suggestion
– Designed to address known US regulatory requirements.
– Identifies key dependencies of Standards-based activities.
– Ability to extend to other HLS Supply Chains and jurisdictions.
Other Suggestions
– Supplemental information.
Rationale
– Supporting information to understand the Team‘s thought process.
Slide 20
EPCglobal Confidential and Proprietary
Unique Identification:
Capability and Suggestions
Slide 21
EPCglobal Confidential and Proprietary
Capability: Unique Identification
(excerpted from SB1476)
Note: California law defines „dangerous drug‟ as a “drug that by federal or state law can be lawfully
dispensed only on prescription or furnished pursuant to Section 4006”. [Section 4022]
• ―A pedigree shall track each dangerous drug at the smallest
[Section 4034(d)]
package or immediate container distributed by the manufacturer,
received and distributed by the wholesaler, and received by the pharmacy
or another person furnishing, administering, or dispensing the dangerous
drug.‖
– Capability needed: identify the prescription drug at the Item level as defined in
California law.
• ―…uses a unique identification number, established at the
[Section 4034(i)]
point of manufacture…that is uniformly used by manufacturers,
wholesalers, and pharmacies for the pedigree of a dangerous drug.‖
– Capabilities needed: assign a unique identification number at point of
manufacture; uniformly use that unique identification number throughout the
supply chain.
Ref: http://www.leginfo.ca.gov/pub/05-06/bill/sen/sb_1451-1500/sb_1476_bill_20060929_chaptered.pdf
or http://www.pharmacy.ca.gov/laws_regs/lawbook.pdf
Slide 22
EPCglobal Confidential and Proprietary
Suggestions: Unique Identification
Serialization
• Uniquely Identify – Pallets, Totes, Cases, Items.
• Unique Identification should be based on Serialization.
– Use current GS1 and EPCglobal serialization schemes appropriate for
the chosen data carrier.
– Synchronize serial numbers when using two or more data carriers:
• SSCC: serial number ranges are the same for both Barcode and RFID.
• SGTIN: serial number range for AI(21) when used as backup for SGTIN-96
should be limited to same range as SGTIN-96.
Answers
one
specific – Avoid encoding of Lot Code and/or Expiry Date as an integral part of
issue; the serial number; instead, encode this data into RFID User Memory
now and/or into barcode Application Identifiers designed for this purpose.
resolved
• Include backup human-readable text per GS1 standards.
• Continue to partner with GS1 Serialization Team to define
global solutions to meet varying serialization challenges.
Slide 23
EPCglobal Confidential and Proprietary
Suggestions: Unique Identification
Serialization
• Use EPCglobal, GS1, HDMA standards and
guidelines.
– Follow current GS1 and EPCglobal standards for use and/or re-use of serial
numbers (standards for SSCC, SGTIN, AI(21) Serial Numbers).
– Companies choosing to use other standards should be prepared to work with
their trading partners to assure interoperability.
• See Appendices for additional suggestions on special-
interest serialization topics:
– Serialized Inference
Inferring reads when less than 100% of data carriers are read.
– NDC Masking This is NOT recommended and does not meet GS1 Stds
Optional, interim practice to mask the Item Reference portion of the 10-digit
NDC in RFID tags to avoid divulging product number for products with patient
privacy concerns.
– Barcode and RFID Co-Existence
Synchronizing serial numbers when using two or more data carriers.
Slide 24
EPCglobal Confidential and Proprietary
Suggestions: Unique Identification
Data Carriers for Serialization
Slide 25
EPCglobal Confidential and Proprietary
Rationale: Unique Identification
• Unique Identification Based on Serialization
– Serialization is the most compatible mechanism to achieve unique
identification using existing standards and data carriers.
• Avoid encoding of Lot and/or Expiry as an integral part of the Serial
Number:
– GS1 and EPCglobal standards support encoding of Lot and Expiry into
Application Identifiers, User Memory, or other appropriate data
structures. Current standards do not support combining these elements
into a single string.
– SGTIN-96 serial numbers allow only numeric values. Lot information is
alphanumeric.
– GS1 and EPCglobal standards require a serial number to be transacted
as a single string and disallow parsing of data.
– Lot and Expiry data format and data values are not standardized
across trading partners; it would be a logistical complication for every
trading partner to know every other trading partner‘s decode scheme.
– Difficult to interpret a single data stream containing up to three
separate data elements in the absence of enabling standards.
Slide 26
EPCglobal Confidential and Proprietary
Rationale: Unique Identification
• Uniquely Identify – Pallets, Totes, Cases, Items
– California legislation requires unique identification at the Item level.
– All packaging levels transacted through the supply chain must be
serialized (in order to maintain the linkage between the serial numbers
and the packaging level hierarchy within the pedigree systems).
• Suggestion to use two data carriers
– Flexibility in data carrier selection allows building of infrastructure that
is data carrier agnostic.
– Mirrors the path that Consumer Goods followed for adoption;
compatible with Consumer Goods supply chain.
– On many products in HLS, there is insufficient space to print human-
readable data as a backup for the RFID tag
– A barcode used in this situation can provide redundancy.
– Redundancy is important to:
• Provide machine-readable backup in case of failure of the RFID tag.
• Provide those companies without RFID capabilities a means to capture the serialized
information via machine-readable methods.
Slide 27
EPCglobal Confidential and Proprietary
Rationale: Unique Identification
• No Solid Suggestion of HF or UHF RFID for Item-Level
– UHF Gen2 standard is available now.
– HF Version 2 standard scheduled for 3Q2007 with tags available later.
– Until HF standard is completed and tags can be evaluated, premature
to make suggestion.
• 2-D Data Matrix barcode for Item-Level
– Provides an alternative for RFID-challenged products (e.g., liquids,
biologics).
– Current uncertainty in RFID Item-Level direction.
– Effective use of available label space for small packaging.
– Potential for compatibility with European (EFPIA) 2-D Data Matrix
barcoding initiatives.
Slide 28
EPCglobal Confidential and Proprietary
Rationale: Unique Identification
• Include human-readable text per GS1 standards and per
recommendations on Slide 23.
– If a Barcode data carrier is present as the sole data carrier, then human
readable text is highly recommended as a backup.
• If possible, include the entire human-readable text string.
• If that is not possible, then at minimum include the serial number portion of the string
(AI 21 or AI 00)—the GTIN can be derived from the packaging.
– If neither of the above are possible, then omit the human-readable text.
Slide 29
EPCglobal Confidential and Proprietary
Rationale: Unique Identification
• SSCC-18 barcode usage for Pallet, Tote, Case
– Serial number portions of SSCC-18 and SSCC-96 are equivalent and
can be easily synchronized to the same value.
– SSCC-18 has been used in many industries for many years, including
within HLS, to serialize various logistics units.
• 2-D Data Matrix barcode usage for Case level
(Use Cases #3 and #5, exception-based)
– Necessary due to the lack of label space on some smaller cases—the
GS1 Code 128 equivalent barcode would be below minimum GS1
specifications or physically would not fit.
– Usage of 2-D Data Matrix barcodes encoding on Cases should be
minimized in Healthcare supply chain
• There are few image scanners to read these barcodes
• There are no GS1 standards to support SSCC data encoded into Data Matrix at this
time.
Slide 30
EPCglobal Confidential and Proprietary
Pedigree:
Capability and Suggestions
Slide 31
EPCglobal Confidential and Proprietary
Capability: Pedigree
(paraphrased from SB1476)
Summary of key language; NOT to be used as a substitute for the actual legislation.
• Means a Record, in Electronic Form,
– Containing information regarding each transaction
– Resulting in a change in ownership
– From sale by manufacturer until final sale to a pharmacy or other dispense point.
– Includes all information required by law
• Created / Maintained in an Interoperable Electronic System
– Contained within a standardized non-proprietary data format and architecture
– Uniformly used by manufacturers, wholesalers, pharmacies for the pedigree
– Ensuring compatibility throughout all stages of distribution
• Tracked at the Smallest Packaging Level (see Serialization Suggestions)
• Certifying that the Pedigree Information is True and Correct
– From a Responsible Party of the source
– Under penalty of perjury
• Returns documented on same Pedigree as the receipt transaction
Ref: http://www.leginfo.ca.gov/pub/05-06/bill/sen/sb_1451-1500/sb_1476_bill_20060929_chaptered.pdf
or http://www.pharmacy.ca.gov/laws_regs/lawbook.pdf
Slide 32
EPCglobal Confidential and Proprietary
Suggestions: Pedigree
• There are two Options to provide a Pedigree:
– Option 1 – Drug Pedigree Messaging Standard
– Option 2 –Track and Trace
• Drug Pedigree Messaging Standard available now.
– Software available today with EPCglobal certifications.
Update:
• Track and Trace in Requirements phase now. Global Traceability
Standard entering
– Standards will follow at a later date.
standards approval
– Then software will be available.
process
• Further suggestions for choosing an Option cannot be
provided until the following is completed for Track and Trace:
– Requirements
– Standards
– Software designed and available which meets Standards
Slide 33
EPCglobal Confidential and Proprietary
Rationale: Pedigree
At this time, the California Board of Pharmacy has no preference for either Option presented
below, and the use of the terms ‗track and trace‘ in the California SB1476 legislation is not
intended to emphasize or endorse any particular option or technology.
[Feedback from EPCglobal Pedigree Meeting with California Board of Pharmacy, Mar. 8, 2007]
• Drug Pedigree Messaging Standard
– The California Board of Pharmacy believes the standard meets
California‘s electronic pedigree requirements.
– However, additional work and amplification by the California
BOP and Industry may be needed.
– In some cases, California regulations may be necessary to
provide the necessary amplification.
• Track and Trace
– Being designed with flexibility to accommodate known
requirements from California and other jurisdictions.
– As with Option 1, additional work and amplification may need to
be done by the California BOP, other jurisdictions, and Industry.
In some cases regulations may be necessary to provide the
necessary amplification.
Slide 34
EPCglobal Confidential and Proprietary
Rationale: Pedigree
• Interoperability between systems based on Pedigree
Messaging Standard or Track and Trace must be
addressed to prevent supply chain and pedigree
disruptions.
– It is likely that both Pedigree Messaging Standard and Track /
Trace will co-exist within the supply chain.
– Therefore, any pedigree initiated under either approach must be
interoperable with both approaches for forward- and reverse-
logistics.
– The following groups are tasked with documenting these
requirements for inclusion into their work products / deliverables.
• EPCglobal Track and Trace Interest Group
• EPCglobal Supply Chain Integrity Joint Requirements Group
• GS1 Traceability in Healthcare Work Group
Slide 35
EPCglobal Confidential and Proprietary
Rationale: Pedigree
• Trading Partner coordination when a pedigree solution
is implemented or changed will be necessary.
– It is likely that trading partners will have some level of effort to complete
in order to use the information from a new pedigree solution.
– Sufficient leadtime for trading partners to react should be planned and
built into the implementation timelines.
– Closely coordinating these types of changes should minimize problems
for all parties.
– Hierarchical shipment data including serial numbers and shipping
information must be communicated in advance to the customer (e.g.,
via pedigree, Rx ASN, Track and Trace or EPCIS transaction).
Slide 36
EPCglobal Confidential and Proprietary
Rationale: Pedigree
• Rx ASN (modified EDI Transaction Set 856, Advance Ship Notice)
does not meet California requirements for pedigree.
– Cannot support ‗certification under penalty of perjury‘.
– Does not exist in an ‗interoperable electronic system widely used…‘
– Does not meet requirement for ‗manufacturer-initiated pedigree‘.
• Rx ASN‘s could be used to facilitate supply chain transactions
(receipts, shipments, etc.).
– ASN‘s support efficient receiving practices.
– Use of ASN‘s will not meet pedigree obligations for jurisdictions
requiring the pedigree in an ‗interoperable electronic system‘.
Slide 37
EPCglobal Confidential and Proprietary
Action Steps
Slide 38
EPCglobal Confidential and Proprietary
Action Steps Overview
• This section expands upon the ‗Begin Vendor & Industry
Adoption‘ activity (see Slide 41).
• The reader will find resources available to facilitate
implementation and adoption activities.
• Additional details can be found in the EPCglobal
Cookbook (referenced in a following slide).
Slide 39
EPCglobal Confidential and Proprietary
Status of Standards and Related Work
Requirements Dev. Standards Development
6 6 0 4 5 10 1 4 16 12 6 4 4
Updated: July 13, 2007 wks wks wks wks wks wks wks wks wks wks wks wks wks
BSC/TSC Review of Recommended
Prototype Test of Proposed Spec.
6
WG Review & Approve Candidate
Tag Data Standards
BSC/TSC Approval of EU Rqmts
Board Ratification of Standard
Collect Business Requests
Define Technical Rgmts w/EU
Develop EU Technical Rqmts
Vendor & Industry Adoption
Technical WG Formation
Standards Development
IAG Business Case Dev.
IAG Business Rqmts Dev.
5
30 DAY IP Review
Track & Trace
30 DAY IP Review
Form WG/ JRG
4
Security
Supply Chain Integrity
Privacy
3 Serialization
2 Item Level Tagging
1 Drug Pedigree Messaging Std
IAG WG IAG WG/JRG TAG WG
Legend: 3 Months 5 Months 10 Months
Previous Progress
Since March 2007
Slide 40
EPCglobal Confidential and Proprietary
Begin Vendor and Industry Adoption
(Activities may or may not be in parallel)
EPCglobal Post-Ratification Activities
Ratified Test and Certified
Standard Create Create Software or
Create Test Certify
~~~~~ Test Test Software
Hardware
Scripts
~~~~~ Platform Guidelines or Hardware ~~~~~
~~~~~
Vendor and Industry Adoption Activities
Process Scale up
Capital System Infrastructure
Re- &
Planning Integration Build-Out
Engineering Implement
Slide 41
EPCglobal Confidential and Proprietary
Key Standards and Other Resources
• EPCglobal
– Standards are available at: http://www.epcglobalinc.org/standards/
– Drug Pedigree Messaging Standard
– Tag Data Standard
– Item Level Tagging Requirements Document
– Gen2 Standard
– EPCIS Standard
– Track and Trace Interest Group Requirements (opt-in required)
http://www.epcglobalinc.org/apps/org/workgroup/hls_t_t_ig/index.php
– EPCglobal Cookbook
• Provides information on how to phase implementations, activities required,
sequencing of activities, development of KPI‘s and metrics, among other
useful topics.
http://www.epcglobalinc.org/what/cookbook
Slide 42
EPCglobal Confidential and Proprietary
Key Standards and Other Resources
• GS1
– GS1 General Specifications (via your GS1 Member Organization)
http://www.gs1.org/productssolutions/barcodes/technical/genspecs/
– GS1 Serialization Team Requirements
(work in progress; join at http://www.gs1.org/hug/Membership/ )
– GS1 GTIN Allocation Rules for Healthcare
(http://www.gs1.org/docs/gsmp/HUG/HUG_GTIN_Allocation_i4.6.pdf )
• FDA
– FDA Compliance Policy Guide, ―Radiofrequency Identification
Feasibility Studies and Pilot Programs for Drugs‖, Nov. 2004
http://www.fda.gov/oc/initiatives/counterfeit/rfid_cpg.html
– FDA Counterfeit Drug Task Force Report: 2006 Update, Jun. 2006
http://www.fda.gov/oc/initiatives/counterfeit/report6_06.pdf
Slide 43
EPCglobal Confidential and Proprietary
Key Standards and Other Resources
• HDMA
– ―Guidelines for Barcoding in the Pharmaceutical Supply Chain‖,
December 2005 edition (available for purchase only)
http://web1.hdma.net/shop/cgi-bin/shopper.exe?preadd=action&key=PUBS261
Slide 44
EPCglobal Confidential and Proprietary
Action Steps
Typical Activities For All Trading Partners
• Engage with your Industry Trade Associations to ensure you have
the most current information regarding policy and positions.
• Work with EPCglobal and GS1 groups to obtain standards,
education, and to learn from others.
• Choose Serialization data carriers for every packaging level. (see
Slide 23)
• Choose Pedigree Option and software. (see Slide 31)
• Develop scale-up and rollout-plans for Serialization and Pedigree
(e.g., based on SKU counts or geographical rollout).
• Work with all affected trading partners with sufficient leadtime on
Serialization and Pedigree choices and options to facilitate efficient
supply chain operations.
– See EPCglobal Public Policy Guidelines for Healthcare Industry.
• Convert operations to apply, commission and aggregate serial
numbers.
Slide 45
EPCglobal Confidential and Proprietary
Action Steps
Typical Activities For All Trading Partners
• Develop, implement, and adhere to effective Privacy standards to
ensure appropriate use of these technologies.
• Install capability to transact serial numbers and serialized
pedigrees—based on specific local regulatory requirements.
• Test serialized pedigree + serialized product final configurations
with trading partners.
• Start shipping serialized and pedigreed products.
– Pallet, Tote, Case, Item Serialization.
– Transact a manufacturer-initiated pedigree.
– With sufficient lead time to load the supply chain with serialized products
supported by a pedigree.
• Execute your Scale-Up / Rollout Plans.
• Retain Pedigree data according to regulatory data retention
requirements.
• Respond to requests for verification of Pedigree data.
Slide 46
EPCglobal Confidential and Proprietary
Summary
and
Recommendations
Slide 47
EPCglobal Confidential and Proprietary
Summary
• The Industry Adoption Task Force has taken the lead in
synthesizing available material into a coherent, forward-looking
Roadmap which can be used by industry trade associations as a
starting point in their discussions with their members.
• The Roadmap describes suggestions to meet the two Key
Capabilities in a balanced yet effective manner.
– Pedigree
– Unique Identification
• The Roadmap provides direction to help reconcile the varied
interests of the diverse set of stakeholders toward common
solutions.
• Providing trading partners with agreed-upon standards and
suggestions for actions reduces complexity, barriers to adoption,
and lowers overall costs for all participants.
Slide 48
EPCglobal Confidential and Proprietary
Recommendations
• EPCglobal Work Teams
– Work with US Drug Enforcement Agency to resolve remaining
questions. [HLS Tri-Chairs / Co-Chairs]
– Ensure that the EPCglobal HLS Track and Trace and Supply Chain
Integrity JRG groups address interoperability of Pedigree Options 1
and 2. [HLS Tri-Chairs / Co-Chairs and the two work groups]
– Work with industry to finalize User Memory requirements for HLS. [HLS
Tri-Chairs / Co-Chairs and all HLS work groups]
Slide 49
EPCglobal Confidential and Proprietary
Recommendations
• GS1 Global Office
– Enable interoperability of GS1 and EPCglobal data carriers to
common URN (Universal Resource Name) or equivalent.
• Common software translation is required to ensure consistency of data captured
and stored within EPCIS network architectures
• Interoperability between trading partners accessing shared data bases
• Handling of GS1 Company Prefix in EPCIS when using a barcode—there is no
‗dot‘ separator character as with an RFID data structure to delimit the variable-
length GS1 Company Prefix
– Work with the various regulatory jurisdictions to resolve conflicting
requirements for serialization and item identification (EFPIA, Japan,
Belgium, Italy, California, France, others). Focus on EFPIA and US
harmonization as a first priority.
– GS1 and EPCglobal to address remaining privacy concerns which will
mitigate the need for NDC Masking practices for RFID data carriers.
– Continue support of the GDSN Healthcare Work Team to adapt and/or
extend GDSN to support serialization and/or pedigree suggestions
presented in the Roadmap.
Slide 50
EPCglobal Confidential and Proprietary
Recommendations
• GS1 Global Office
– Work with industry and EDI standards groups to include flags in
the ASN (or Rx ASN) structure indicating which data carrier
contains the serialized information (e.g., RFID or Barcode).
– Work with industry and EDI standards groups to prepare a
standard for Rx ASN transaction set, including that Rx ASN
should be considered as the means to exchange the serialized
numbers and the serialized hierarchy between trading partners.
– Commission a study comparing UHF, HF, 2-D Data Matrix
solutions (with and without Serialized Inference), to determine
potential cost-effectiveness for each supply chain partner type.
• Supporting data needed for trading partners to decide on unique
identification.
• Suggest study by Academic University, MIT Auto-ID, or independent
group.
• Initial work by MIT can be found at:
http://autoidlabs.org/single-view/dir/article/6/221/page.html
Slide 51
EPCglobal Confidential and Proprietary
Recommendations
• FDA
– Provide test results to industry regarding impact of RF energy
on Biologics, at minimum on UHF and HF frequency ranges.
-Initial testing for worst-case heating induced electric fields found at
(http://www.rfidjournal.com/whitepapers/download/77)
-PQRI Paper describing test protocol and initial results:
(http://www.pqri.org/pdfs/RFID_Report_to_FDA_23Mar2006.pdf)
– Determine next steps for Compliance Policy Guide,
―Radiofrequency Identification Feasibility Studies and Pilot
Programs for Drugs‖, Nov. 2004.
Document expires on 31-Dec-2007.
Slide 52
EPCglobal Confidential and Proprietary
Recommendations
• FDA
– Work with industry to establish an on-going forum for discussion
and joint resolution of questions.
– Need FDA guidance on what prevailing controls apply to
serialization (for example, is this GMP-related or subject to other
controls).
– Need FDA guidance on standardized language or symbology
indicating the presence of an RFID tag on a pharmaceutical
product.
– Assess impacts of Proposed Rule to change NDC numbering
scheme and process to allocate the NDC‘s on SGTIN, GTIN,
Pedigree, Track and Trace, and other key elements of this
Roadmap.
– Need FDA guidance on regulatory filings required to apply RFID
at item-level over the long-term (current CPG addresses pilot
activities only, and does not include liquids or biologics).
Slide 53
EPCglobal Confidential and Proprietary
Recommendations
• FDA
– Need FDA guidance on protecting Biologic products from
exposure to RF energy in RFID-enabled supply chains.
Example: re-directing those products to avoid RFID tunnels,
turning off RFID reader when Biologic products present in a
reader field, etc.
– FDA Barcode Regulation may need to be updated to allow:
• 2-D Data Matrix as alternative to linear barcode.
• FDA did confirm with the IATF that there is no barrier to encoding a serial
number into the existing linear barcode, or applying an additional 2-D Data
Matrix barcode for serialization, so long as:
– It does not affect readability of the NDC number encoded in the barcode.
– It does not cause the product to be misbranded.
Slide 54
EPCglobal Confidential and Proprietary
Recommendations
• HDMA
– Update the HDMA Barcode Guidelines document with the
following suggestions; provides consistency to a widely-used
industry based document:
• To reflect the RFID and barcode recommendations in this Roadmap.
• To harmonize requirements with current GS1 and EPCglobal
standards, where there are meaningful differences.
Slide 55
EPCglobal Confidential and Proprietary
Recommendations
• Industry Trade Associations
– Educate membership on standards and available resources.
– Work with membership to develop positions and policy regarding
adoption.
– Work with other Trade Associations to review policy, positions,
regulatory issues and/or guidance to minimize supply chain disruptions.
– Engage additional participation from Generic, Biological, Secondary
Wholesaler industry trade associations and their members.
– Work with key regulatory bodies on education and outreach;
communicate adoption policy and positions; identify areas for
regulatory clarification and/or guidance.
– Work with GS1 and EPCglobal to globally harmonize requirements.
– Actively engage with EPCglobal regarding standards.
– Provide guidance to members on methods for prioritizing efforts.
Slide 56
EPCglobal Confidential and Proprietary
Appendices
Appendix 1
Suggestions: Serialized Inference
Business Problem:
• California SB1476 at Section 4034(b)(3) requires the ―name and address of
each person certifying delivery or receipt‖.
• This ‗certification‘ of item-level serial numbers presents new challenges:
– Line of sight technology would result in opening every case and scanning every item within,
since the item serial numbers are not visible.
– Non-line of sight technology, if less than 100% of the items were read, would result in
opening every case and scanning every item within.
– Opening cases at time of receipt introduces new risks, is time-consuming, and adds costs
into supply chain operations.
One Potential Suggestion:
• Inference is one of many mechanisms to enable trading partners to
leverage strong supply chain practices to meet these challenges.
• Adoption of any solution to these challenges remains an individual
company decision.
• The California BOP has scheduled working sessions with industry to better
understand these challenges. Regulatory guidance may result from these
working sessions.
Slide 58
EPCglobal Confidential and Proprietary
Appendix 1
Suggestions: Serialized Inference Definitions
• Infer (Inference): Conclude from evidence (Webster‘s Dictionary).
• Working Definition: To infer the serialized number based on
information provided by the upstream supply chain, reasonable
inspection of the product, and application of the Serialized
Inference Rule by the Shipping and Receiving partners.
• Serialized Inference Rule: The process a supply chain partner
uses to ensure there is enough evidence to infer the serialized
number without physically reading ALL serialized numbers. A
Serialized Inference Rule should be defined for each packaging
unit (e.g., pallet, case, item, etc.) for the key process steps of
Commission/Aggregation, Ship, and Receipt.
Enhance Patient Safety in the supply chain by allowing supply chain partners
to leverage the good business practices initiated by manufacturers which are
then continued through the supply chain by downstream trading partners.
Slide 59
EPCglobal Confidential and Proprietary
Appendix 1
Suggestions: Serialized Inference
Assumes that each Trading Partner follows good business
practices, such as:
• Good manufacturing and good distribution practices.
• Documented controls and Standard Operating Procedures.
• Captures quality metrics to minimize ―defects‖ of inbound
and outbound product.
• When process errors are detected, implements changes to
those processes to prevent future errors.
• Processes are periodically reviewed for improvement
opportunities.
Slide 60
EPCglobal Confidential and Proprietary
Appendix 1
Suggestions: Serialized Inference
To summarize, Serialized Inference is possible when the following conditions
have been achieved:
• A collection (item, full or mixed case, tote, pallet, etc.) is present.
• The collection is identified with a unique serial number, and each member
of the collection (item, case, tote, pallet) is also identified with a unique
serial number.
• The receiving trading partner receives an electronic communication
containing the serialized numbers and the hierarchical relationship of those
serialized numbers within the collection.
• The receiving trading partner must have assurance that the collection has
remained intact since leaving the last trading partner.
– If the receiving trading partner has reason to believe that the collection has not remained
intact since leaving the last trading partner, then inference should not be used.
These inference suggestions are intended to provide each trading partner with an
understanding of how inference can be used by all the various supply chain
participants. The application of inference remains an individual business decision.
Slide 61
EPCglobal Confidential and Proprietary
Appendix 1
Suggestions: Serialized Inference
Designed for transactions between trading
Serialized Inference Scenarios: partners, however can be applied to intra-
• Single Item Commission company transactions as well.
– Apply serial number to one single Item.
• Item into Case Commission/Aggregation
– Apply serial number to Case and build item-to-case hierarchy.
• Case to Pallet Commission/Aggregation
– Apply serial number to a homogenous pallet comprised of Cases of all one
product and build case-to-pallet hierarchy.
– May be a full pallet or a partial pallet.
• Tote or Mixed Case Commission/Aggregation
– Apply serial number to Case or Tote containing either a mixture of SKU‘s or
1 or more items of a single SKU, and build item-to-case hierarchy. Typically
conducted as part of a pick/pack/ship operation.
• Mixed Pallet Commission/Aggregation
– Apply serial number to Pallet of mixed Cases or Totes, and build case-to-
pallet or tote-to-pallet hierarchy. Pallet could contain mixed cases and/or full
cases. The full cases could be from one product or from multiple products.
Slide 62
EPCglobal Confidential and Proprietary
Appendix 1
Suggestions: Serialized Inference
Designed for transactions between trading
Serialized Inference Scenarios: partners, however can be applied to intra-
company transactions as well.
• Shipments
– Single Item Shipment (one single item shipped)
– Case Shipment (all one item)
– Tote or Mixed Case Shipment (One or more items or mixed items,
typically part of a pick/pack/ship operation)
– Pallet Shipment (all one item on a pallet)
– Mixed Pallet Shipment (mixed items on a pallet)
• Receipts
– Single Item Receipt (one single item received)
– Case Receipt (all one item)
– Tote or Mixed Case Receipt (One or more items or mixed items,
typically conducted as part of a pick/pack/ship operation)
– Pallet Receipt (all one item on a pallet)
– Mixed Pallet Receipt (mixed items on a pallet)
Shipments and Receipts of pallet, case, mixed case, and tote assumes the hierarchy
and packaging integrity remained intact from the Commission/Aggregation process.
Slide 63
EPCglobal Confidential and Proprietary
Appendix 1
Serialized Inference Rules:
Commission/Aggregation
Use Case Scenario Manufacturer Wholesaler Retailer DC Pharmacy
Inference Inference Inference Inference
Single Item Commission Read - I NA NA NA
Item into Case Read - I NA NA NA
Commission/Aggregation
Case to Pallet Read - C NA NA NA
Commission/Aggregation Infer - I
Tote or Mixed Case Read - I Read -I NA NA
Commission/Aggregation
Mixed Pallet Read – C,T Read - C,T NA NA
Commission/Aggregation Infer - I Infer - I
Assumes
Key: ―P‖ Pallet ―C‖ Case ―T‖ Tote or Mixed Case ―I‖- Item Aggregation
has Occurred
Slide 64
EPCglobal Confidential and Proprietary
Appendix 1
Serialized Inference Rules: Shipments
Use Case Scenario Manufacturer Wholesaler Retailer DC Pharmacy
Inference Inference Inference Inference
Single Item Shipment Read - I Read - I NA NA
Case Shipment Read - C Read - C NA NA
Infer - I Infer - I
Tote or Mixed Case Shipment Read - C,T Read - C,T NA NA
Infer - I Infer - I
Pallet Shipment Read - P Read - P NA NA
Infer - C, I Infer -C, I
Mixed Pallet Shipment Read - P Read - P NA NA
Infer - C, T, I Infer - C, T, I,
Key: ―P‖ Pallet ―C‖ Case ―T‖ Tote or Mixed Case ―I‖- Item Assumes
Aggregation
has Occurred
Slide 65
EPCglobal Confidential and Proprietary
Appendix 1
Serialized Inference Rules: Receipts
Use Case Scenario Manufacturer Wholesaler Retailer DC Pharmacy
Inference Inference Inference Inference
Single Item Receipt Read - I Read - I Read - I Read - I
Case Receipt Read - C Read - C Read - C Read - C
Infer - I Infer - I Infer - I Infer - I
Tote or Mixed Case Receipt Read - C,T Read - C,T Read - C,T Read - C,T
Infer - I Infer - I Infer - I Infer - I
Pallet Receipt Read – P Read - P Read - P NA
Infer - C,I Infer - C,I Infer - C,I
Mixed Pallet Receipt Read – P Read - P Read - P NA
Infer – C,T,I Infer – C,T,I Infer – C,T,I
Assumes
Key: ―P‖ Pallet ―C‖ Case ―T‖ Tote or Mixed Case ―I‖- Item Aggregation
has Occurred
Slide 66
EPCglobal Confidential and Proprietary
Appendix 1
Serialized Inference Rules:
Recalls, Returns, Reverse Logistics
Use Case Scenario Manufacturer Wholesaler Retailer DC Pharmacy
Inference Inference Inference Inference
Single Item Receipt/Shipment Read - I Read - I Read - I Read - I
Case Receipt/Shipment Read - C Read - C Read - C Read - C
Infer - I Infer - I Infer - I Infer - I
Tote or Mixed Case Read - C,T Read - C,T Read - C,T Read - C,T
Receipt/Shipment Infer - I Infer - I Infer - I Infer - I
Pallet Receipt/Shipment Read - P Read - P Read - P NA
Infer - C,I Infer - C,I Infer - C,I
Mixed Pallet Receipt/Shipment Read - P Read - P Read - P NA
Infer - C,T,I Infer - C,T,I Infer - C,T,I
Key: ―P‖ Pallet ―C‖ Case ―T‖ Tote or Mixed Case ―I‖- Item Assumes
Aggregation
has Occurred
Slide 67
EPCglobal Confidential and Proprietary
Appendix 1
Serialized Inference Rules: Repacking
Use Case Scenario Aggregation Shipping Receiving
Inference Inference Inference
Single Item Read - I NA NA
Case Read - I Read – C Read – C
Infer – I Infer - I
Tote or Mixed Case Read - I Read – C,T Read – C,T
Infer - I Infer - I
Pallet Read - C Read - P Read - P
Infer - I Infer - C,I Infer - C,I
Mixed Pallet Read - C,T Read - P Read - P
Infer - I Infer - C,T,I Infer - C,T,I
Key: ―P‖ Pallet ―C‖ Case ―T‖ Tote or Mixed Case ―I‖- Item Assumes
Aggregation
has Occurred
Assumes repackers will receive serialized product, then serialize
outbound product, and retain the linkage between inbound and
outbound serial numbers (if different or changed).
Slide 68
EPCglobal Confidential and Proprietary
Appendix 2
Suggestions: NDC Masking
• NDC Masking is an optional, interim method to address privacy
concerns until a fully ratified GS1 and/or EPCglobal numbering and
serialization standard or guideline is available.
• This method applies only to RFID and other technologies that do
not rely on line-of-sight scanning.
– NDC Masking does not apply to barcodes.
• Also consider that NDC Masking may alert others that this product
is ‗sensitive‘ and therefore may draw unwanted additional attention.
• Process to mask an NDC in the SGTIN format:
– Set the Item Reference equal to all zeros.
– Ensure for all items using a masked NDC that the serial numbers are unique
across all of those product SKU‘s within a single GS1 Company Prefix (the Item
Reference is no longer part of the key since it equals all zeros for those
products).
– All other elements of the SGTIN remain unchanged.
– An example is shown on the following slide.
NOTE:
NDC Masking is NOT recommended practice and does not comply with GS1
standards. This slide recognizes that the practice does occur and seeks to
avoid multiple methods in deploying the practice
Slide 69
EPCglobal Confidential and Proprietary
Appendix 2
Suggestions: NDC Masking
Illustration of NDC Masking at the Item Level
GS1 Company
Prefix
Data Format Indicator Country Labeler Item Reference
Digit
Code Code
NDC ------ -------- 0001 1234 98
GTIN 0 03 0001 1234 98 3
SGTIN ------ 03 0001 0 1234 98 _
Check
Digit Omitted
mSGTIN ------ 03 0001 0 0000 00 _
(masked NDC) (Item Reference = zeros)
This is NOT recommended and does not meet GS1 Stds
Notes:
a. Packaging Level Indicator changes position in SGTIN.
b. Check Digit is omitted in SGTIN.
Slide 70
EPCglobal Confidential and Proprietary
Appendix 3
Suggestions: RFID and Barcode Co-Existence
Why Suggestions are Needed:
• To avoid the assignment of more than one unique serial number on
a single packaging level, when multiple data carriers are used.
• Tracking more than one unique serial number on a single
packaging level creates unnecessary complications and increases
the chances for errors by all trading partners.
• There are differences in the serialization schema in the various
standards which must be understood to ensure that the serial
numbers are synchronized across the data carriers.
• Emphasize that information systems must be capable of handling
the entire 20-digit alphanumeric AI(21) serial number range.
– This range will be encountered in AI(21) barcode applications today.
– When SGTIN-198 is adopted, will encounter this range for RFID as
well.
• Shows placement of AI(21) barcode in similar location as SSCC-18
barcode would have been placed to facilitate physical handling.
Update:
Slide 71 Parsing is the main barrier to coexistence and is being
EPCglobal Confidential and Proprietary resolved
Appendix 3
Suggestions: RFID and Barcode Co-Existence
Note: Data is for illustration only; see GS1 Standards for usage
SSCC-96 SGTIN-96
030001.5 1234567890 030001. 2 123498. 123456789012
RFID
EPC Mgr ID Extension Digit (5) EPC Mgr ID Serial Number
+Serial Number Indicator Digit (2)
+Item Reference
SSCC-18 AI(01) AI(21)
Barcodes
(00)5 030001 1234567890 3 (01) 2 030001 123498 7 (21)123456789012
Extension Digit (5) Serial Number Indicator Digit (2) Serial Number
+EPC Mgr ID + Check Digit (3) +EPC Mgr ID Item Reference
+ Check Digit (7)
This table is intended to illustrate synchronizing serial
numbers between RFID and Barcode data carriers. It is
NOT intended as guidance on choosing data carriers.
Slide 72
EPCglobal Confidential and Proprietary
Appendix 3
Suggestions: RFID and Barcode Co-Existence
Single-SKU Case with AI(21) Mixed Case/Tote/Pallet with SSCC
Std. Placement
RFID Tags shown are for illustration and do not imply an endorsement of any particular supplier.
Slide 73
EPCglobal Confidential and Proprietary
Appendix 3
Suggestions: RFID and Barcode Co-Existence
Item-Level Label with SGTIN-96 RFID Tag + Data Matrix Barcode
RFID Tags shown are for illustration and do not imply an endorsement of any particular supplier.
Slide 74
EPCglobal Confidential and Proprietary
Appendix 3
Suggestions: RFID and Barcode Co-Existence
• AI(00) SSCC (Serialized Shipping Container Code)
– The RFID and Barcode SSCC serial number ranges are
compatible in current GS1 and EPCglobal standards.
– Suggestion: When both RFID and Barcodes are used for SSCC
serialization on a single packaging level, synchronize the SSCC
serial numbers (both serial numbers equal).
Slide 75
EPCglobal Confidential and Proprietary
Appendix 3
Suggestions: RFID and Barcode Co-Existence
• AI(21) Serial Number as Backup for RFID SGTIN
– AI(21) serial number range is 20 digits alphanumeric.
– SGTIN-96 serial number range is limited to:
• 0 through 274,877,906,943 (inclusive), numeric-only, no leading zeros
allowed (unless the entire serial number consists of a single zero).
• This limitation is resolved with SGTIN-198, which encodes the full range of
AI(21) values.
– Suggestion: When AI(21) is used as a backup for SGTIN-96
serial numbers:
• Synchronize the RFID and Barcode serial numbers (both serial numbers
equal).
• This is accomplished by limiting the range of the AI(21) serial numbers to
correspond with the SGTIN-96 range in this particular situation.
– Suggestion: When AI(21) is used without RFID tag, the full
range of 20-digit alphanumeric values may be used.
Slide 76
EPCglobal Confidential and Proprietary
Appendix 4
Definitions
• AI (Application Identifier)
– The field of two or more characters at the beginning of an Element
String that uniquely defines its format and meaning. (adopted from GS1
General Specifications, v7.1)
– Commonly used AI‘s in healthcare include:
• AI(00) SSCC
• AI(01) GTIN
• AI(10) Lot/Batch
• AI(17) Expiry
• AI(21) Serial Number
• AI(30) Quantity
Slide 77
EPCglobal Confidential and Proprietary
Appendix 4
Definitions
• ASN (Advance Ship Notice)
– Advanced Shipping Notice. This is a type of EDI transaction
(transaction code 856). The ASN contains information regarding a
specific shipment of product from a seller to a buyer and is transmitted
prior to the arrival of the shipment. The fields, data and level of
granularity (shipment, pallet, case, etc.) is determined by the trading
partners. (adopted from Drug Pedigree Messaging Ratified Standard,
V1.0)
• Data Matrix Barcode (for serialization)
– A standalone, two-dimensional matrix symbology that is made up of
square modules arranged within a perimeter finder pattern. Data Matrix
ISO version ECC 200 is the only version that supports GS1 System
identification numbers, including Function Code 1. Data Matrix Symbols
are read by two-dimensional imaging scanners or vision systems.
(adopted from GS1 US Glossary, v6.0)
Slide 78
EPCglobal Confidential and Proprietary
Appendix 4
Definitions
• Drug Pedigree
– A record of each distribution of a prescription drug from the sale by a
Manufacturer through acquisition and sale by any Wholesale Distributor
until final sale to a Pharmacy or other authorized person administering
or dispensing the Prescription Drug. (adopted from Drug Pedigree
Messaging Ratified Standard, V1.0)
• ECC200
– Data Matrix ISO version ECC 200. See Data Matrix Barcode definition.
• EDI
– Electronic Data Interchange
• Electronic Pedigree
– An electronic record containing all data and information required by one
or more pedigree laws including the necessary certifications. (adopted
from Drug Pedigree Messaging Ratified Standard, V1.0)
Slide 79
EPCglobal Confidential and Proprietary
Appendix 4
Definitions
• EPC (Electronic Product Code)
– An identification scheme for universally identifying physical objects
(e.g. trade items, assets, and locations) via RFID tags and other
means. The standardized EPC data consists of an EPC (or EPC
Identifier) that uniquely identifies an individual object, as well as an
optional Filter Value when judged to be necessary to enable effective
and efficient reading of the EPC tags. (adopted from GS1 General
Specifications, v7.1)
• Gen2 (Generation 2)
– Refers to EPCglobal Class 1 (base class) passive-backscatter, radio-
frequency identification (RFID) system operating in the UHF 860 MHz –
960 MHz frequency range. (adopted from EPCglobal Gen2 Standard,
Version 1.0.9).
• GTIN (Global Trade Item Number)
– The GS1 Identification Key used to identify trade items. The key is
comprised of a GS1 or U.P.C. Company Prefix followed by an Item
Reference Number and a Check Digit. (adopted from GS1 General
Specifications, v7.1)
Slide 80
EPCglobal Confidential and Proprietary
Appendix 4
Definitions
• HF (High Frequency)
– Refers to current ISO or future EPCglobal radio-frequency identification
(RFID) system operating in the HF 3 MHz – 30 MHz frequency range,
typically at 13.56 MHz for HLS applications. (IATF Definition).
• HLS
– Health and Life Sciences industry. (IATF Definition)
• IATF
– EPCglobal HLS Industry Adoption Task Force. (IATF Definition)
Slide 81
EPCglobal Confidential and Proprietary
Appendix 4
Definitions
• (Serialized) Inference Rule
– The process a supply chain partner uses to ensure there is enough
evidence to infer the serialized number without physically reading ALL
serialized numbers. A Serialized Inference Rule should be defined for
each packaging unit (e.g., pallet, case, item, etc.) for Aggregation,
Shipping and Receiving processes. (IATF Definition)
• Item Reference
– The part of the Global Trade Item Number (GTIN) allocated by the user
to identify a trade item for a given GS1 Company Prefix. (adopted from
GS1 US Glossary, v6.0)
• NDC (National Drug Code, US)
– A 10-digit number that must be assigned to pharmaceuticals sold in the
USA per federal law. The number comprises a Food and Drug
Administration (FDA) assigned Labeler Code and manufacturer
assigned Product ID and SKU/Trade Pack Size number. An NDC may
be represented within a Global Trade Item Number (GTIN). (adopted
from GS1 US Glossary, v6.0)
Slide 82
EPCglobal Confidential and Proprietary
Appendix 4
Definitions
• NDC Masking
– The process of replacing the Item Reference portion of the SGTIN with
zeros to avoid divulging the underlying NDC number. (IATF Definition)
• RFID
– A data carrier technology that transmits information via signals in the
radio frequency portion of the electromagnetic spectrum. A Radio
Frequency Identification system consists of an antenna and a
transceiver, which read the radio frequency and transfer the information
to a processing device, and a transponder, or tag, which is an
integrated circuit containing the radio frequency circuitry and
information to be transmitted. (GS1 US Glossary, Version 6.0)
• Rx ASN (Prescription Advance Ship Notice)
– A non-standard, trading partner-specific EDI ASN transaction set
(based on EDI 856 transaction set) incorporating additional information
(such as Lot, Expiry, Rx Drug Serial Number, License Numbers) helpful
in facilitating receiving, shipping, and other logistics processes for Rx
drug products. The Rx ASN is one of the means to exchange the Rx
Drug serialized numbers and the serialized hierarchy between trading
partners. (IATF Definition)
Slide 83
EPCglobal Confidential and Proprietary
Appendix 4
Definitions
• Serialization
– Schema, processes, and controls for assignment of serial numbers to
items. (IATF Definition)
• Serialized Inference
– To infer the serialized number based on information provided by the
up-stream supply chain, reasonable inspection of the product, and
application of the Serialized Inference Rule by the Shipping and
Receiving partners. (IATF Definition)
• Serial Number
– A code, numeric or alphanumeric, assigned to an individual instance of
an entity for its lifetime.
• Example: Microscope model AC-2 with serial number 1234568 and
microscope model AC-2 with serial number 1234569.
– A unique individual item may be identified with the combined Global
Trade Item Number (GTIN) and serial number.
– Specific instance of the Object Class being tagged.
– (Adopted from GS1 General Specifications, v7.1)
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EPCglobal Confidential and Proprietary
Appendix 4
Definitions
• SGTIN (Serialized Global Trade Item Number)
– To create a unique identifier for individual objects, the GTIN is
augmented with a serial number, which the managing entity is
responsible for assigning uniquely to individual object classes.
The combination of GTIN and a unique serial number is called a
Serialized GTIN (SGTIN).
– The SGTIN consists of the following information elements:
• The Company Prefix, assigned by GS1 to a managing entity. The Company
Prefix is the same as the Company Prefix digits within a GS1 GTIN decimal
code.
• The Item Reference + Indicator Digit, consisting of the GTIN‘s Item
Reference prepended by GTIN Indicator Digit. The Item Reference and
Indicator Digits are assigned by the managing entity to a particular object
class.
• The Serial Number, assigned by the managing entity to an individual object.
The serial number is not part of the GTIN code, but is formally a part of the
SGTIN.
– (Adapted from EPCglobal Tag Data Standards Version 1.3,
Ratified Specification).
Slide 85
EPCglobal Confidential and Proprietary
Appendix 4
Definitions
• SKU (Stock Keeping Unit)
– An individual color, flavor, size, or pack of a product that requires a
separate identification number to distinguish it from other items (a
measure of an item of merchandise for inventory management). In
inventory control and identification systems, it represents the smallest
unit for which sales and stock records are maintained. (adopted from
GS1 US Glossary, v6.0)
• SSCC (Serial Shipping Container Code)
– The GS1 Identification Key used to identify logistics units. The key is
comprised of GS1 Company Prefix, Extension Digit, Serial Reference,
and Check Digit. (adopted from GS1 General Specifications, v7.1)
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Appendix 4
Definitions
• Trace
– The capability to identify the historical locations, the records of
ownership, and the packaging hierarchy for a particular traceable item.
“Trace” answers questions such as “where has the item been”, “who
has previously owned the item”, and “in what packaging hierarchy did
the product exist at various locations”. The EPCglobal Pedigree
Messaging Standard v1.0 is one example of a Trace mechanism.
(IATF Working Definition)
• Track
– The capability to identify the current (and at time of shipment the
intended future) location, ownership, and packaging hierarchy of a
traceable item through the supply chain as it moves between parties.
(based on GS1 Traceability Standard).
– “Track” addresses both forward- and reverse-logistics operations.
“Track” answers questions such as “where is the item currently”, “who
is the next intended recipient”, and “what is the current packaging
hierarchy of this item”. (explanatory information added by IATF)
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Appendix 4
Definitions
• Track and Trace
– The combined capabilities of “Track” and “Trace” as previously defined.
Addresses both forward- and reverse-logistics operations.
(IATF Working Definition)
• UHF (Ultra High Frequency)
– See Gen2 definition.
• Unique Identification
– See definitions for Serial Number and Serialization.
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Appendix 5
Industry Associations Providing Comments
• NACDS: National Association of Chain Drug Stores
• HDMA: Healthcare Distribution Management Association
• PhRMA: Pharmaceutical Research and Manufacturers of America
• GPhA: Generic Pharmaceutical Association
• BIO: Biotechnology Industry Organization
• NCPA: National Community Pharmacists Association
• CPhA: California Pharmacists Association
• GS1
• EPCglobal
• On-Track (Accenture-led cross-functional industry pilot)
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