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EDITION
SERIALIZATION PLAYBOOK
Strategies for navigating the changing landscape
PHARMACEUTICAL TRACK-AND-TRACE
Updated
2014
FOR
Update on legislation The business case Project management tips Line & plant strategies CMO/CPOs & trading partners Software & architecture Pilot testing guide Rollout strategies Vendor selection guide
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Please see specific serialization offerings from these vendors in the Vendor Selection Resource Guide.
TABLE OF CONTENTS
CONTRIBUTORS
7
A list of experts contributing to this Playbook
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22 25 26 31 36 39
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TABLE OF CONTENTS
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49 55
81 84 85 87 88
How to avoid a big barcode gotcha Label and panel redesign considerations Impact on production line speeds and OEE Validation considerations for serialization Impact on production/operations workflows
TABLE OF CONTENTS
SECTION 4: THE SUPPLY CHAIN: BEYOND
91 97 99
E-pedigree models and the U.S. drug supply chain Impact on wholesaler/distributors, pharmacies, clinics, and hospitals Contract manufacturing and contract packaging strategic considerations
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103 Five implementation tips for CMO/CPOs 105 builds its own serialization solution 109 Questions to ask your CMO/CPO about serialization
Case study: Contract packager
TABLE OF CONTENTS
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144 Expert Network 145 Questions to ask serialization solution providers 148 Vendor Selection Resource Guide
Disclaimer All information in this Playbook was peerreviewed and believed to be accurate at presstime. Please be aware that technologies, standards, and regulations will continue to evolve, which may cause parts of this Playbook to become temporarily outdated between regular planned updates.
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CONTRIBUTORS
DIRK RODGERS
President RxTrace
The following experts contributed their extensive serialization experience to this Playbook:
CO-EDITORS:
BILL FLETCHER
Managing Partner Pharma Logic Solutions
While this Playbook was researched and written by the Healthcare Packaging editorial staff, some articles were contributed by Dirk Rodgers, who along with Bill Fletcher, thoroughly peer-reviewed its contents and served as co-editors for this project.
ROBERT CELESTE
Director, Healthcare GS1 US
MICHAEL STEWART
Strategic Business Planning, Track & Trace Projects PharmTech, Inc.
SEAN MULHOLLAND
Senior Quality Compliance Officer Almac Pharma Services
DAVID MASON
Packaging Engineering Consultant
GREG CATHCART
CEO Excellis Health Solutions
NEVILLE NOEL
Managing Partner Endeavor Consulting Group
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STEPHEN MCINDOE
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JIM JOHN
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Section One
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If the DQSA is signed into law by the President, as most expect, several things will happen right away. First and foremost, all current state and federal serialization Source: Dirk Rodgers Consulting and pedigree laws (yes, including This chart represents the projected estimate of the percentage of pharmaceutical SKUs that will be serialized in the U.S. California) will be preempted. This drug supply chain over the next few years, as estimated by Dirk Rodgers of RxTrace.com. will result in the elimination of the with a single approach to supply chain security as outlined in frequently discussed patchwork Title II of the DQSA. of U.S. drug pedigree laws in one fell swoopto be replaced
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3% (21)
3% (10)
4% (25)
1% (8)
5% (19)
3% (10)
8% (55)
13% (88)
56%
(366)
13% (47)
49%
(184)
14%
U.S. respondents
Non-U.S. respondents
Respondents from both the U.S. and overseas report that around half have not yet begun the process of choosing the serialization system and a primary contractor.
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All data exchanges will have to be electronic; The unit-level SNIs of each drug package will have to be
included in the transaction information that is passed to each customer;
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the addition of the expiration date and serial number in the barcode, companies can more readily determine if they have, or have had, a particular lot of a product in their inventory.
Wider implications: With an estimated 60% to 80% of raw ingredients for drug manufacturing coming from foreign shores, serialization can be coupled with track-and-trace of raw materials from receiving to finished product delivered to end user (hospital, pharmacy, patient). This helps batch recall by tracing back to original ingredients, and providing day and workshift identification.
item that is held in consignment inventory can increase trust levels between trading partners in terms of tracking accuracy.
www.kmedipak.com
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CartonTracker
North America +1 418 688 0334 United Kingdom +44 7805 800 381 Belgium +32 475 50 6966 France +33 610 59 1948 Asia +91 9099 37 5045
optelvision.com
Serialization should How are the drugs shipped today? deliver organizational And how long is product left sitting in storage versus immediate delivery? flexibility to respond to any global Are there any current plans to expand distribution to other regions of the business opportunity. world or relocate manufacturing? If properly implemented, it should allow manufacturers to prepare a correctly labeled package to meet any state or countrys rules and regulations, now and in the future, with as little customization as possible. The key is flexibility. Dont design and build a system that complies with Californias regulations, but cant handle Japans move to single-line barcode. (Japan has recently updated its serialization requirements to replace
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6% (26)
Looking for CA-compliant solutions
16% (122)
11% (46)
Looking for global solution
48% (361)
62% (260)
26%
20%
U.S. respondents
Non-U.S. respondents
Nearly half of U.S. respondents say they are waiting for a global solution to the serialization scheme, while among non-U.S. respondents, the percentage is even higher, at 62%.
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STANDARD
GLN GTIN, SSCC, GRAI, GIAI, GSRN GLN
Ship-From, Ship-To, Buyer, Seller Products, Logistics Units, Assets, Relationships Postal Locations, Warehouses, Floors, Rooms Time and Date Commissioning, Packing, Shipping, Receiving, Dispensing
Business Step
With so many players in the supply chain poised to exchange data, its important that the industry coalesce around a common set of standards to ensure interoperability and scalability of integrations.
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GS1 GTIN Global Trade Item Number GS1 UPC barcode symbology G S1 element strings encoded in a barcode symbology such
as GS1-128, GS1 DataMatrix, GS1 DataBar
GS1 EPC RFID in frequencies including UHF and HF GS1 Electronic Product Code Information Services (EPCIS) GS1 Drug Pedigree Messaging Standard (DPMS) GS1 Global Data Synchronization Network (GDSN)
Any company wishing to make use of GS1 standards including barcodes, identifiers, and data exchange standards must first obtain a GS1 Company Prefix or GCP. Normally you would obtain a GCP by applying for GS1 membership in the country where your company headquarters resides. But if your company makes drugs for the U.S. market, regardless of where you are located, you will need to obtain
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The GS1 Company Prefix is at the core of the GS1 System, the set of standards used globally for identification of Dont know products, services, Yes assets, relationships, and even documents. Building your No serialization strategy using these GS1 Source: 105 pharmaceutical manufacturers and contract packagers surveyed October standards will help 2012 by Healthcare Packaging. you comply in as many GS1 is clearly going to be the standard countries around the at the package coding level, and from all world as possible. evidence, at the information exchange layer as well. Brazil, India, and South Korea have explicitly named GS1 identification standards in their regulations or in their guidance. The GCP can vary between six and 10 digits in length, and
38% 55% 7%
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continued
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GIAI (Global Individual Asset Identifier)up to 30 characters GSRN (Global Service Relation Number)18 digits GDTI (Global Document Type Identifier)13 digits plus
optional serial number up to 17 additional digits
Each type of GS1 key includes a numeric value that is combined with the GCP to form a specific instance of the key. It is the assignment of these numeric values that must be managed in some way. The total length of the key minus the length of the GCP determines how many digits are available to the owner to assign specific instances of the key. These digits represent the key space for a given key. The shorter the GCP, the larger the key spaces of each key type will be.
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ERP System
Central Repository
A. SSCC Identification:
An SSCC (Serial Shipping Container Code) is an alternative to the GTIN + Serial Number format. Some of the digits are specific to a company, whereas the other digits are used to identify a unique number for each labeled package. The SSCC does not identify the product. Even though the SSCC serial number format is meant to identify the packaging level that is shipped out (usually pallets), it is fully EPCIS-compatible (for the aggregation record) and, once in the warehouse, it becomes 100% clear that the partial container is different from the others. An SSCC allows the case and its contents to be indicated within an Advanced Shipping Notice (ASN), DPMS e-pedigree envelope, and/or EPCIS events, which is where the recipient should look for contained quantity.
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Level 3
Level 0 ... 2
Line Controller
Manual Packaging
www.werum.com
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Utilizing the worlds fastest and highest resolution ink jet print head technology, the InteliJet HD meets the increasingly rigorous demands for printing dates, times, bar codes, serial numbers and text on Tyvek, Paper and Poly films.
02
Since a case label normally states the quantity (both in a barcode and in human-readable text), using the same label
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E. No Serial Number
This method consists of simply not applying a case label on the partial containers. Only the label of an item level (e.g., a bottle label) is applied to the case in order to indicate the product type. This is a way to stay GS1-compliant if the PES is unable to print dedicated label schemes for partial containers. An SSCC will eventually be applied before shipment. The trouble with this approach is that all of the full cases will have a serial number (SGTIN) established at case packing time, but the partial will not have one until shipment from the distribution center. That might cause problems with internal track-and-trace.
Recommendation
Until all manufacturers align their methods so that downstream trading partners can expect consistency, methods for dealing with partial containers should be evaluated on the following criteria:
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Certifications
A certification is nothing more than a corporate assertion of truthfulness of the track-and-trace data, incorporated into the e-pedigree information itself. This feature is intended to make it easier to prosecute criminalsone of the important components of track-and-trace regulations. Not all country regulations require you to include this within your track-and-trace data, but your track-and-trace solution must be able to include this assertion if you expect to meet future e-pedigree requirements. Some people tend to confuse a digital certificate with what California requires, which is simply that you provide information
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Pedigree reporting
If a country or state regulation requires e-pedigree reporting, your solution needs to supply it. The problem here is that many of the global requirements are not well
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Source: GS1 US
The mission of GS1: Identify, Capture, and Shareidentification numbers, data carriers, and standards for electronic commerce.
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K E Y C O N C E P T
Generically, this refers to the ability of data or information created by one computer system to be read by another. In terms of serialization, it can be applied in multiple ways. At the level of the physical flow of packages and cases, it can mean the ability of a trading partners scanning systems to scan a barcode (or RFID tag) generated by the manufacturer or contract packager. At the e-pedigree or data-sharing level, it typically refers to the ability of a trading partner to be able to read (or query) another trading partners data via a common protocoltypically Electronic Product Code Information Services (EPCIS).
out by explaining the concept of data carrier independence, which lies at the foundation of the GS1 System. It then explains the data carrier-specific forms that are built on top of that foundation, including: Barcode scanner output
EPC Tag URI EPC Binary Encoding RFID User Memory Encoding (packed objects)
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continued
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Section Two
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Key areas where cross-functional involvement is critical are at the high-level design phase of planning where all the different pieces of your solution are defined, and at interfaces between different functions, organizations, and systems. Touchpoints that did not exist in the traditional packaging paradigm extend beyond the packaging line, crossing over to
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ERP System
Central Repository
Level 3
Level 0 ... 2
Line Controller
Manual Packaging
www.werum.com
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2%
Packaging (49) Compliance/Validation (31)
3% (10)
Compliance/Validation
2% (6)
Brand Protection
7%
5%
1%
Business
19% (126)
7%
2% (6)
24% (89)
Other
9%
We dont really have a serialization team (58) Supply Chain Management (100)
10% (36)
15%
Other
13% (87)
Production/Mfg. Operations (96)
10% (39)
Information Technology (88)
Packaging
16% (60)
Business
13%
15%
11% (42)
15% (55)
Non-U.S. respondents
Information Technology
U.S. respondents
Business managers are the most likely to spearhead the serialization effort in the U.S., whereas for non-U.S. respondents, production/operations is most likely to head up the team.
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accuracy matters
You may not see them, but you know they exist; the smallest imperfections that, if not eliminated, compromise the safety of your product, reputation and bottom line. Backed by 65 years of inspection experience, Thermo Fisher Scientic delivers durable, reliable, accurate solutions to meet the exacting demands of the pharmaceutical industry.
continued
Thermo Scientific Versa Rx Checkweigher High accuracy and high rate to meet demanding pharmaceutical applications.
This marking and verication system option for track and trace applications can be added to the Versa Rx standard checkweigher.
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1. Identify the specific regulations you are complying with, keeping in mind that this is somewhat of a
moving target.
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Assemble your serialization team and get stakeholder buy-in Map existing internal business processes affected by serialization Analyze country and state regulatory requirements Determine your core requirements Define your architecture, core components, and system interfaces Determine data carriers, codes, and label designs Build and install the solution Standards conversion Conduct training Perform internal test & validation Test CMO/CPO integration and validation
Survey capabilities of trading partners Perform an impact analysis Leverage industry groups to learn standards and influence the approach (PhRMA, EFPIA, GS1) Talk with your trading partners Create user requirement specifications Develop use cases Conduct vendor assessments Identify sites, lines, SKUs for pilot testing Pick internal and external event data capture and sharing model Test wholesaler/distributor integration and validation Determine if serialization solution scales with multiple sites, trading partners Build serialization competencies throughout the company
4. Pilot testing
5. Rollout
Create your own serialization playbooks Finalize master plan for compliance by market
Develop rollout plan by site site, line line, and trading partner
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7. From a regulatory standpoint, decide what will be handled in-house vs. outsourced.
Some companies maintain in-house resources to keep up with regulatory changes with regard to serialization. Others subscribe to third-party subscription services or use independent subject-matter experts who may be
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8. Identify factors that will influence technical architecture. Look closely at the impact of data volume,
especially from the packaging-line level all the way up through the enterprise and supply chain. Tabulate the GTIN/SKUs, lines, plants, and the total volume of items, cases, and pallets. Serialization generates an enormous amount of data, and with it, the task of managing it properly. Cases and pallets may not have GTIN or SSCC now, but may need them for serialization. Look at the regulatory requirements: What are the processes, reporting formats, and consolidation requirements? Decide whether to handle the connectivity to different parties internally or by relying
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stories in the industry of companies that have picked vendors, bought technology, and then started hemorrhaging cash because they didnt have an end-to-end plan. In one example, the IT folks were fashioning IT strategy in a vacuum without talking to packaging and regulatory departments. Meanwhile the packaging engineering team was out buying equipment without talking to IT. Without a team in place and a plan to follow, internal politics sunk the project, and the equipment had to be completely discarded. True story.
Serialization and e-pedigree on pharmaceutical packaging lines. Seidenader T&TSolutions consist of the MLS enterprise gateway software, the Process Manager line-level serialization software, and strategic line-level devices, including In-Sight smart camera technology.
www.kmedipak.com
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How is number format conversion between the plant and the enterprise managed? How are new country requirements managed?
How are network interruptions minimized to ensure packaging throughput? How are evolving changes to existing legislation managed? How does the serialization solution impact line efficiency? How many unique HMI displays does the serialization solution require?
Is a third party responsible to provide the tools necessary to maintain data integrity? Is a third party responsible for code changes?
Are packaging lines isolated or insulated from plant and enterprise level changes? What impact will changes to the devices have on the line management system?
Does the serialization solution manage the line or just the serialization devices? Does the serialization solution positively track the status of the item throughout the line processes?
Some questions to ask as you contemplate each level of your serialization architecture.
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1. Investing in skills and resources of operators and technicians. A mistake many companies make is to
not build up the skills required for serialization on the part of the operators and technicians responsible for day-to-day running and maintenance of the packaging lines. Instead the tendency is to develop dependencies on vendors for support. By not empowering plant personnel with the resources and skill sets necessary to troubleshoot the technology, the people running these lines will be at a huge disadvantage when it comes to troubleshooting problems and taking corrective action.
3. Integration challenges with MES and enterprise layers. In the last four years, companies have
been so focused on testing serial number management that they havent focused on integrating the serialization solution into their core business systems (see software implications).
2. Ensuring that aggregation can be counted on 100% of the time. It might be extra work and extra cost,
with a potential hit on line performance, but the method of aggregation you choose must yield reliable aggregation data
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11. Dont wait for uncertainty to be resolved in order to start. Companies that have already begun piloting
with serialization caution against waiting for regulations and standards to be finalized before beginning your serialization project. Both regulations and standards are undergoing constant evolution. Dont wait any longer. You just need to dive in! The rest of this Playbook shows you how.
10. Serialization projects take longer and are more complicated than you think. The entire effort
is often underestimated simply because we are all heading into uncharted waters. Large global pharmaceutical companies report a pilot test from start to finish can easily take a year, and its often a case of two steps forward, one step back. Then
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Section Three
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9% (68)
1% 5% (27)
Clamshell (9)
1%
8%
Blisters
4% (27)
Trays
15% (103)
14% (104)
Ampules (53)
7%
Bags/Pouches (38)
6%
5% (38)
Bags/Pouches
14% (106)
Syringes (43) Cartons (230)
5%
6%
Vials
6%
Vials
31%
34%
10% (67)
9% (67)
Non-U.S. respondents
U.S. respondents
Cartons and bottles lead the packaging formats that pharma companies intend to serialize as they implement a serialization scheme. For non-U.S. companies, blister packaging draws even with bottles.
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footprints.
Offload some SKUs to contract packagers. Creative solutions include pre-encoding labels or
cartons offline the day before packaging with serial numbers and using existing label application or cartoning systems. Cameras may then be installed at case packing to commission item serial numbers and record aggregation. Plan for power and equipment failures, such as hard drives in control systems. How do you account for data loss in various modes of equipment failure or loss of power? Integrating your serialization strategy into existing lines,
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Source: 105 pharmaceutical manufacturers and contract packagers surveyed October 2012 by Healthcare Packaging
especially complex machinery like cartoners or case packers, requires involvement from your original equipment partners. Tap into their experience with other customers to save time and money.
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continued
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been collected for the shipment? They are sealed inside of cases, and the unit-level serial numbers are not visible. One option would be for the distribution center staff to cut open each case in the shipment, pull the units out, and scan each unit-level serial number on the drug packages, then put them all back into the cases and reseal them. Thats obviously impractical. A better option would be to use inference to infer which unit-level serial numbers are included in the shipment. For that to work, the case-packing operation would need to include unique serial numbers on each case and then capture the unit-level serial numbers as they are being packed into the cases. The unit-level serial numbers would then be associated with the case-level serial number. This is known as unit-to-case aggregation information, and it may include unit-to-bundle and then bundle-to-case aggregation, and/or case-to-pallet aggregation as well. Now, when the distribution center needs to know exactly which unit-level serial numbers to include on their customers pedigree, all they need to do is read the serial numbers on the cases included in the shipment, and then use the unit-to-case aggregation information in reverse. That is, they would infer the units from the case serial numbers.
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Aggregation consists of electronically associating individual serial numbers to a serial number that represents the grouping. In this example, there is an aggregation for bundles (consisting of individual bottles), and of cases (consisting of bundles). Not shown is the final aggregation, pallets (consisting of cases). Each parent receives its own serial number that is electronically associated with the serial numbers of the children. Thats the basis of the electronic pedigree.
via 2D barcodes, which appears to be the direction most pharma manufacturers are going for serialization for California. With the massive volume of drugs that pass through the large companies in the U.S. supply chain today, the use of inference by all parties in the supply chain will help prevent costs from skyrocketing, not to mention eliminate the introduction of new errors and theft (thus actually lowering the security of drugs in the supply chain).
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orders and update the corresponding e-pedigrees to reflect the shipment to their customer. However, some customers order in quantities large enough for the distributor to simply deliver one or more entire cases of a drug. In that instance, the distributor doesnt need to open the manufacturers case, and so they would rely on the manufacturers aggregation information to know exactly which unit-package serial numbers are being shipped to their customer, so they can update and pass the correct unit-level e-pedigrees to their customer. The distributor would pass on the manufacturersupplied aggregation information to their customer for the cases that were shipped, along with the e-pedigrees for the packages contained within them. Since the distributors customer will also want to receive their shipment as efficiently as possible, they will likely make use of the aggregation information to update the e-pedigrees that they received from the distributor so that they do not have to open every case and read the serial numbers on every package inside them. Notice that in this scenario, the manufacturer distribution center, the distributor, and the distributors customer are all relying on the accuracy of the aggregation information that was
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it on to their customer. That customer would then have to update the corrected e-pedigree, thus finally clearing the way to sell, return, or dispense the drugs. Thats a lot of very inefficient interaction. In the meantime, the drugs sit on the shelf unusable. So for inference to work, the manufacturers aggregation information must be 100% accurate. Failure to maintain accurate aggregation may have an effect on the availability of your brand in the market and confidence in the product, and result in shortages while inference issues are resolved.
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AGGREGATION
K E Y C O N C E P T
Aggregation refers to assigning child-level serial numbers (such as on individual packages) to a unique serial number at the parent level (e.g., a case), thus forging an electronic association between the children and the parent so that the numbers in the sealed container can be inferred. Each time goods are grouped, thats an occasion for aggregation: individual unit packages to bundles; bundles to cases; cases to pallets. Aggregation is essentially an electronic data representation of grouped goods, sometimes interchangeably used with hierarchy. Regardless of what you call it, the electronic representation must always match the physical, or else bad things will happen.
inspection and rework. The reason this works is that RFID doesnt require a line-ofsight to read. That is, the RFID reader can read directly through the corrugated case material and pick up all of the tags in a very short time. The benefit is that this operation would produce 100% reliable aggregation, and so inference (see inference) could be relied upon as a downstream strategy.
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those numbers with the case-level serial number for the case thats being loaded. The benefit of this type of inspection is that it requires minimal modifications to the packaging line, which lowers costs and reduces the validation burden. The drawback, however, is that its prone to unreliability. If a bottle is removed or falls off the line after that vision inspection occurs, the sequence of bottles will get out of sync by one. That means incorrect aggregation information is attributed to not only that case, but also every case after it. This risk can be reduced by maintaining the count of items and detecting when an item was removed after entering the case packer and another item is needed to complete the case. Camera inspection systems may be used to confirm a complete count, and control systems can eject cases with questionable aggregation. Inaccurate aggregation in a case packer would be a disaster from a data integrity standpoint. Which leads to the third, and likely most realistic, option for most pharmaceutical manufacturers: post-aggregation inspection. The way to always generate 100% accurate aggregation information is to read the unit-level serial numbers only
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Temporary bottom codes can be scanned in one image, after the grouping is formed.
Source: Omega Design
Temporary 2D code
Some vendors have come up with a workaround. It entails the use of a temporary 2D barcode that is ink-jet printed onto the bottom of all empty bottles. This barcode contains a unique bottle identification number, or bottle ID, that is unique for all of the bottles within the current batch of the drug being bottled. The purpose of this barcode is to keep
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track of each bottle as it progresses through the packaging line and into secondary packaging operationsshrink bundlers, cartoners, case packers, etc. As bottles emerge from the labeler, a vision system would verify that the 2D DataMatrix code (along with lot and expiration date) is readable. A second vision system would read the temporary 2D bottle ID code. The packaging line management system would then create a one-to-one relationship of the real serialized NDC number
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DataMatrix code containing serialized NDC is on the side of the bottle, separate from the temporary 2D code on the bottom.
Source: Optel Vision
encoded in the DataMatrix barcode with the temporary 2D code printed on the bottom. (This is not aggregationits a one-to-one relationship thats used only during the packaging process.) Once the bottles are shrink-bundled or grouped for loading into a case, a vision system would take a picture from the bottomthus capturing all of the temporary 2D codes in one image. Once the line system knows which bottles are in that
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1. Define where on the package you want to print. As in real estate, the three most important factors here
are location, location, location. Whether its on a top flap, one end flap, or both end flaps, the physical location of the code
2. Specify exactly whats going to be on the label. Prepare a label schema document for your coding/
Though early pilots relied on RFID, companies are standardizing on 2D DataMatrix code plus human-readable text.
Source: Almac Pharma Services
marking vendor that specifies exactly what elements are to be printed. You should also endeavor to have a drawing or rendering of what the finished, printed label should look like,
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2013
Install & validate serialization solutions.
2014
Manufacture to build product inventory.
2015
50% of all products serialized per California e-pedigree requirement.
4. Assess whether your existing coding equipment is serialization-ready. The trick here
is not in the printing of a 2D code, as even printers upwards of eight years old can do that. To be truly serialization-
1.800.444.4512
www.domino-na.com
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are typically going to be thermal ink-jet (TIJ), laser ablation coding, or some form of print-andapply. If you are switching away from CIJ, this means you may need to alter some internal processes and factor in some additional training of operational teams. Considerations will include substrate, line speed, material handling, and printer
mounting. For TIJ, dry time differences across similar carton stocks can be meaningful. Line speed constraints for laser are a function of substrate, lens size, code size and complexity, product pitch, code orientation, and power requirement. Line speed constraints for TIJ are dependent largely on the chosen
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TickTock
2015 is approaching
6. Vibration on the line can impact printing (and scanning). When choosing conveyor components
for the transport of bottles across areas of the production line where coding takes place, be on the lookout for potential vibration.
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Can the coder process serialized data quickly enough for the application? Does the coding system provide the ability for the host system to monitor Does remote troubleshooting exist?
Source: Domino
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BottleTracker
Ideal Association Station for Track & Trace
North America +1 418 688 0334 United Kingdom +44 7805 800 381 Belgium +32 475 50 6966 France +33 610 59 1948 Asia +91 9099 37 5045
optelvision.com
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returned, resulting not only in unnecessary costs, but also in product shortages. How to avoid this? Thats where what is known as barcode grading comes in. The readability of any barcode can be graded on a scale of 0.0 to 4.0 (F to A). Grades are based on many different parameters, including sharpness of edges, quiet zone, overlap of bars or symbols, relationship of one square to another within a 2D code, etc. So it is entirely possible for the first package of the run to have a grade B, and the last package to end up with a grade D
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Verify to ISO Standards Check for Duplicate Numbers Inspect for Print Defects Control Waste HDMA Compliant 21 CFR Part 11 Compliant Ready
www.lvs-inc.com
+1-770-487-6414
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validation change might require three signatures: the person initiating the change, one level up, and the plant manager. A validation change at the corporate levelsay for a change in a business process may require 15 or 20 signatures. Thats two weeks versus two days. That two-week process simply wont fly with all the changes that serialization requires. As a direct Sample User Requirement result of dealing Specification for with serialization, serialization some companies Download this user requirements are issuing revised starter document complete with sample language that you can internal procedures modify and adapt to your own needs. for how they handle validation changes at DOWNLOAD the corporate level, bit.ly/serialize-sample-urs to streamline such Source: ProPharma Group, Inc. validation changes.
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Section Four
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166,000 Pharmacies
Figure 1. Proportions of the three primary segments of the U.S. pharmaceutical supply chain. Counts for the manufacturers and pharmacy delivery points are from the HDMA (2009). The number of pharma distributors was estimated based on the list of corporate entities found in the Authorized Distributors of Record (ADR) lists of several large pharma manufacturers found on the Internet. Keep in mind that more than 90% of the volume of drugs passing through the supply chain goes through only three distributors.
Figure 1 shows a view of the supply chain where the vertical scale shows something closer to the true proportions between those three segments. The most striking thing about this view is that it shows
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UP TO 1,400 CONNECTIONS
Source: RxTrace
Figure 4. View of the U.S. pharma supply chain from a typical distributor. The typical distributor in the U.S. buys their drugs from most of the drug manufacturers, and sells those drugs to many pharmacies. The three largest distributors each sell and deliver to tens of thousands of pharmacies.
company must deal with to a minimum. While the traditional approach with AS2 is to exchange digital certificates, other techniques do exist to simplify establishing encryption and security for exchanging trading information and certifying the exchange. These include techniques used for consumer online banking, health information, and business virtual private networks (VPN). AS2 actually provides for encrypted communications while
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Bell-Mark has a full line of Ink Jet printers capable of printing UDI, Serialized Codes, Logos, Barcodes, Variable Data, Product Info and much more on a wide range of materials.
? W O N K U O Y DID
Printed with the 600dpi, InteliJet HD Print small or large characters, graphics and bar codes
02
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e-Pedigree Compliance
The Race Is On
continued
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Source: 105 pharmaceutical manufacturers and contract packagers surveyed October 2012 by Healthcare Packaging
Whatever your answer is, multiply it by the total number of trading partners.
to establish, test, and validate an electronic data connection with a single external trading partner (see chart). One things for certainthat time frame will almost certainly be measured in months, not weeks. In addition to the connectivity, CMO/CPOs have to figure
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1. Make sure your serialization solution can interface to multiple client company ERP systems. Most serialization solutions are designed to
interface to enterprise systems within a single company, but not all of them are designed to connect to ERP systems across multiple companies. In other words, the plant-level serialization solution at a given CPO must not only talk to that CPOs enterprise-level serial number management solution (such as SAPs Aii module), it must talk to the Aii module (or equivalent) at each of its pharma client companies and keep that data separate. This is a challenge specific to CMO/CPOs that they need to keep in mind when shopping for a serialization solution. To simplfy the exchange of serialization information, many companies are turning to time-tested and widely used solutions
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2. Be flexible in receiving or originating serial numbers. Most pharma client companies will choose to
allocate serial numbers and send them to the CMO/CPO, but there may be some occasions where the CMO/CPO needs to originate the numbers. The serialization solution must be flexible enough to handle either requirement (or serial numbers generated by government agencies). CMO/CPOs will need to figure out how to easily toggle from their own serial number management to a clients (or a governments) with each job.
3. Support serialized and non-serialized product from the same customer. We will be living in a mixed
serialized and non-serialized world for the foreseeable future. Your systems should be able to handle both simultaneously.
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5. Determine how to support varying label requirements. Your system will need to account for the The INTEGRA 95XX Series Barcode Verifiers
Verify the barcode Identify the problems Simplify the process Certified by GS1 US HDMA Compliant 21 CFR Part 11 Compliant Ready
following customer requirements: Summary of actual requirementFor example, full serialization versus an enhanced encoding.
www.lvs-inc.com
+1-770-487-6414
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In addition to serializing packages at the item level, OPSIS supports aggregation at the case and pallet level. To date, aggregation at Almac has been a manual process, including case and pallet label scanning, due to the small batch sizes involved. Almac says the potential for automatic aggregation of units
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DRIER
RED CUBE
VISION SYSTEM
16
Almac engineered its own portable serialization system utilizing off-the-shelf components and its own custom software.
exists; however, use of this function has not been required so far. OPSIS provides for controlled handling of rejects, rework, quality assurance sampling, and in-process checks. Batch-specific label information is set up well in advance of production by the scheduling department, and is approved
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34% Dont
know
33% Yes
How are exceptions handled? Do you have the ability to handle both serialized and nonserialized product?
32% No
Source: 105 pharmaceutical manufacturers and contract packagers surveyed October 2012 by Healthcare Packaging.
Lack of awareness of trading partner readiness signals a lack of attention being paid to this critical part of the serialization puzzle. E-pedigree isnt done in a vacuumby definition it means connecting to someone outside your four walls.
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Section Five
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Network EPCIS
Pedigree
(DPMS, EPCIS)
Government Reporting
Mobile Authentication
LEVEL 3: Site level/Serialization manager LEVEL 2: Packaging line automation network LEVEL 1: Devices
Acsis, Xyntek-Antares, Mettler-Toledo, Optel Vision, Seidenader (Krber Medipak), Systech, etc.
Barcode Printer
RFID Reader
Code Reader
Applicator
Plant and DC
Enterprise
Network
that people typically focus on during pilot testing. But theres more to serialization integration than serial number management. To create recipes within the serialization solution, a lot of material master data that has nothing to do with the serial number itselffor example, GTIN information, package item information, multipack counts, case counts, pallet counts, and variable formats for label filesneeds to flow into the serialization solution as part of a recipe. That data resides in enterprise systems. Figuring out how it gets into the serialization solution is the trick. During pilot testing, its common for this type of information to be entered manually into the serialization system. But when youre running 15or 50packaging
A proper serialization program extends way beyond the packaging line, up through the enterprise and out to the entire extended supply chain.
PACKAGING
Source: Pfizer & Tracelink
DISTRIBUTION
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2. All trading partners must follow a common interpretation of EPCIS events and extensions for each use case. This includes:
1. All trading partners must adopt the EPCIS guidelines in the same way. This includes:
Which combination of EPCIS events is used for each use case Which event business steps and dispositions are used Which GS1 US Healthcare extension data elements are used
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EXCEPTIONS In the world of serialization, an exception is an event that happens in the supply chain that interferes with or is not part of the expected flow of goods from manufacturer to wholesaler/distributor to pharmacy/clinic/hospital. Examples include damaged product, returns, incorrect pedigree information, etc. A working group within GS1 is currently maintaining a list of such exceptions (see next page ) with an eye toward augmenting the EPCIS business vocabulary to account for them.
3. Watch out for dependencies, repurposed data elements, and precedence relationships:
supply chain partners. A classic example is the relationship between the commissioning event and the aggregation event. If your software assumes that the event time for when the aggregation occurs must always be after the commission time, it creates a potential point of failure. Thats because it is possible for the item- and case-level aggregations to have identical event times, depending on how aggregation capture is implemented on the packaging line. Overly restrictive rules that make assumptions about one event preceding the other could cause product to be rejected by a downstream trading partner. If in doubt, check with your supply chain partners to confirm you are both following and interpreting guidelines in the same way before you begin exchanging event data.
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exceptions. The list can be found in the current Rx Guideline (www.gs1us.org/RxGuideline). The next version of the guideline is expected to provide the choreography of EPCIS events that trading partners can use to address problems if they occur.
Exception 12: Pedigree Contains Incorrect Product Information Exception 17: Received Physical Product From An Unidentified Sender
Exception 13: Pedigree Exception 18: Missing Contains Incorrect Reference# Information Exception 9: Physical Inventory Exception 19: Could Not Read Overage (Concealed Overage) Pedigree Data Due To Security Exception 14: Pedigree (Or Mismatch EPCIS Ship Event) Not Received Exception 10: Physical By Customer Inventory Shortage (Concealed Exception 20: Pedigree Data Shortage) Not In Correct Format Exception 15: Undelivered Shipment Exception 11: Pedigree Exception 21: Good Product Contains Incorrect Customer/ Damaged Barcode Or RFID Location Information Exception 16: Lost Shipment
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3. Different companies may request different formats with different data element names depending
on their EPCIS implementation.
4. Supply chain master data changes over time. Package configurations, dosage changes, and other
product details may change over time. A manual data exchange process is an inefficient (and tough to validate) way of transmitting those updates. As you scale your deployment, it becomes important to automate the file format and the method for exchange. Some thoughts to keep in mind as you ponder supply chain master data:
motivated by challenge
When it came to nding the right partner for integrating key checkweighing equipment into their pharmaceutical demo line, Omega Design Corporation chose Thermo Fisher Scientic. Omega Designs dedicated serialization lab required a reliable solution to demonstrate data sync on their line; Thermo Fisher Scientic rose to the challenge, delivering a reliable, accurate solution.
driven by commitment
For more information on Thermo Scientific pharmaceutical product inspection solutions visit: www.thermoscientific.com/checkweighers
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Verify who is asking or providing information about the product: Legitimate company in the supply chain? Have they actually had possession/ownership of the item they are asking about? Verify who is answering my questions: Legitimate company in the supply chain? Are they who they say they are? Can I trust the answer to my question?
the vectors of attack. It is possible for someone to pose as the manufacturer and falsely pass EPCIS data to a wholesaler/ distributor. (A secure communication mechanism such as AS2 is designed to prevent such hijacking of identity.) The fundamental question is one of authentication: How do
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PILOT TESTING
Section Six
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2. Assess the impacts on line efficiency and uptime. This breaks down into several sub-areas:
M easure and record impacts to line efficiency D efine mitigation plans to reduce line efficiency impacts D efine inventory build-up plans to mitigate risk of inventory
stock-outs during serialization implementation
1. Understand the potential organizational impacts. This could mean gaining a better understanding
of the implementation process, the impact on company resources to roll out serialization, the need for external support, and the costs, or assessing the feasibility of the requirements
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We started our first serialization pilot test prior to 2011 We started our first serialization pilot test in 2011-2012 We will start our first serialization pilot test by 2013
Source: 105 pharmaceutical manufacturers and contract packagers surveyed October 2012 by Healthcare Packaging
As of October 2012, nearly half of respondents have yet to begin pilot testing.
5. Assess how trading partners prefer to receive serialization and aggregation data. Some may prefer
ASN, though the industry is moving toward EPCIS.
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Unit RFID read rates during packaging Unit RFID read rates during distribution Unit 2D barcode read rate Case label reject rate Pallet label reject rate Unit-to-case aggregation exceptions Case-to-pallet aggregation exceptions Unit/case/pallet aggregation accuracy Duplicate serial number exceptions Time to serialize one lot
Average time to process a pallet shipment Time for unit-to-case aggregation Time for case-to-pallet aggregation Time for case-to-pallet disaggregation Serialized ASN exceptions Pedigree creation/processing/signing exceptions Integration exceptions between serialization Integration exceptions between EDI
and RFxcel infrastructure and EDI
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9. Assess network-centric pedigree models as they are defined. There are several models defined by GS1
that consist of variations on centralized, semi-centralized, or distributed. You may want to try different models to assess the pros and cons of each approach.
8. Identify exceptions and best practices for handling exceptions. Currently not all supply chain
events can be depicted in EPCIS. These exceptions tend to consist of reverse logistics such as returns (possibly due to shipping errors) or recalls (for a complete list, see pitfalls). This
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Picking partners
While it may be tempting to focus solely on internal testing for your pilot, its not a true test unless a trading partner can scan your code and reconcile that with the e-pedigree data youre sending. Identifying pilot partners is not so much a matter of willingness, since many may express interest, but rather a question of whether they have capabilities in place to receive serialized product and serialized data. They also need a commitment not only from their organization but also from their solution providers to work with you to test the process. Finally, they need to have the dedicated resources in place to be able to follow through with all of the work associated with a pilot test.
Management of all subcontractors and schedules Changes in packaging equipment hardware and software A ddition of new equipment to enable serialization
(printing, inspection)
System troubleshooting IQ, OQ / PQ T raining of operational personnel and other site functional
groups
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1. Exchange and pre-test samples of serialization encoding and carriers, such as sample
2D DataMatrix barcodes, before starting the pilot to flush out barcode reader and format compatibility issues.
3. Exchange and process EPCIS events in test systems before starting the supply chain pilot to flush out issues quickly. This can save a lot of
time in the supply chain pilot process, especially for EPCIS interoperability issues such as supply chain master dataexchange requirements, consistent use of EPCIS event and extension data for supply chain use cases, consistent use of company and location identifiers in EPCIS events, and precedence relationships of EPCIS events (see pitfalls for common interoperability issues).
2. Agree on how EPCIS events and vocabulary will be exchanged. Test the communication link (e.g., AS2 or
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4. Consider producing more serialized product than you need for your current pilot. That allows you to
respond to trading partners that request serialized product for their pilots without having to touch your production line.
2. Getting adequate testing time on production lines can be a major challenge. Especially for highrevenue products and highly utilized production lines, it can
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7. Give your wholesaler/ distributor a headsup when the first serialized pilot
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continued
4. Dedicate a project management resource to each external vendor. This helps properly manage
delivery.
With the most Track and Trace labeling installations in the industry, LSI can prescribe a hardware and data integration solution within your budget. Our integrated solutions serialize and verify relationships from the unit, bundle, case, and pallet levels with both 2D barcode and RFID technology. Contact us today for a free consultation on your Track and Trace initiatives at 201.405.0767 or lsi@labelingsystems.com
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Printing and reading codes 1. Move 2D barcodes away from other barcodes on the label. Multiple barcodes, such as a UPC/EAN and a
DataMatrix, on a label should be separated so that scanning is more efficient and accurate. This is especially important for hand scanningin some situations operators had to cover a traditional linear barcode with their finger so that it would not be read.
2. Use a fixed barcode scanner on the conveyor that can read across the conveyor. 3. Watch for vibration. It can affect both printing and
scanning.
4. Make sure label roll changes on label printers dont cause serial numbers to get out of sync. In
one pilot, when the printer ran out of labels, the system buffered
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7. Use rails and clear covers to control access to serialized items on the packaging line. This helps to
control sampling and product movement.
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4. Disaggregating units from a case (or cases from a pallet) before aggregating to a shipment is inefficient. Manual rework and aggregation is extremely
labor-intensive and error-prone. A process is needed that supports scanning once to perform both functions.
2. Physical keyboards are easier to use than virtual ones. On-screen keyboards are difficult to use and
slow down the process.
3. Adding serialized barcodes on cases in addition to normal barcodes may cause confusion. Workers may not know which barcode to scan;
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Easily manage your pilot with the tools and resources provided Find pilot partners through GS1s industry network C onnect with industry members that can share experiences
specific to your pilot
Get started quickly using a ready-made pilot structure Join established pilots Design your own pilot based on individual readiness and needs
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4. Create a process for bleeding out nonserialized inventory while you are introducing serialized
inventory and managing what gets shipped to whom.
2. Coordinate with your customer service personnel when initial pilot orders are placed to permit such
orders, even though they are for (smaller) nonstandard ordering quantities.
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6. Create differentiated processes for managing nonserialized and serialized product at the unit, case, and pallet level.
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Section Seven
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Ask our roster of supplier experts in the Serialization Playbook expert network!
Franco Diaz Mark Shaffer Tim Lydell
Product Manager Packaging Security, CCL Label Phone: (201) 370-2120 fdiaz@cclind.com
Pharmaceutical Business Dev. Mngr., Domino Phone: (609) 306-0298 mark.shaffer@ domino-na.com
CEO, Label Vision Systems, Inc. Phone: (770) 487-6414 x229 timl@lvs-inc.com
Bill Minaeff
Dean Hornsby
Director of Bus. Dev. for Consumer Pkg. Goods, Matthews Marking Sys. Phone: (412) 526-1327 hornsby@matw.com
Lee Brown
Jean-Pierre Allard
Serialization Product Manager, Optel Vision Phone: (418) 688-0334 x6211 jean-pierre.allard@ optelvision.com
Business Dev. M anager, Omega Design Corp Phone: (413) 537-9906 Unitlevel@omega design.com
Michael Stewart
VP Business Development, PharmTech Phone: (847) 281-8924 mstewart@pharm techinc.com
Leonard R.Valeo
Sales Manager Serialization Solutions, Seidenader Phone: (609) 647-5051 valeo@kmedipak.com
Philippe Maraval
VP Sales and Marketing, Weiler Labeling Systems Phone: (847) 812-6263 pmaraval@weilerls.com
Kevin Zarnick
Pharma Industry Mgr-NA, Thermo Fisher Scientific Phone: (814) 449-2874 kevin.zarnick@ thermofisher.com
Elliot O. Abreu
Senior Vice President, Xyntek, Inc. Phone: (215) 493-7091 x227 elliota@xyntekinc.com
Hendrik Harms
Mngr Sales & Bus. Consulting, Werum Software & Systems AG Phone: +49 4131 8900-833 harms@werum.de
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CCL Label
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CCL Label
technologies will be tailored to meet your unique business requirements, strategic goals, and existing technologies here, now, and in the future. CCL will work with you to ensure regulatory compliance with domestic and foreign laws, and we will support you with secure, quick-to-market global launch capabilities, through a coordinated network of manufacturing facilities and dedicated professionals.
Contact CCL Label today to gain more knowledge on how we can help you fulfill all your serialization needs.
products and healthcare supply chains. Proven Anti-Counterfeiting, Brand Protection, and Diversion technologies are employed to protect healthcare stakeholders from todays immediate challenges through tomorrows 2015 drug pedigree requirement. KEY SERIALIZATION CONTACT
Franco Diaz, Product Manager - Packaging Security PHONE: (201) 370-2120 LOCATION: Hightstown, NJ EMAIL: fdiaz@cclind.com
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Domino
A thorough understanding of serialization A breadth of technologies to meet varying needs A global presence and proven scalability
Domino brings more to the discussion
Domino has committed significant resources throughout the years to develop and implement global solutions that comply with all relevant industry standards and regulations, such as 21 CFR Part 11, GAMP 5, CFIA, and the U.S. FDA. Close collaboration with OEMs, vision system manufacturers, and integrators on these projects has led to excellent overall performance of the system, not just the code quality, to the satisfaction of customers, and has thus led to the successful implementation of the statutory requirements.
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Domino
Interaction with global regulatory bodies, such as GS1, ensures that Domino remains at the leading edge of requirements to ensure solutions are reliable, scalable, and future-proof.
Mark Shaffer, Pharmaceutical Business Development Manager PHONE: (609) 306-0298 LOCATION: Gurnee, IL EMAIL: mark.shaffer@domino-na.com
COMPANY: Domino
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Labeling Systems
Labeling Systems
With more Track & Trace labeling and marking solutions in the field than any other leading labeling equipment manufacturer, Labeling Systems (LSI) is uniquely qualified to integrate Track and Trace technology into any packaging line. The first critical piece of tracking the chain of custody of a product occurs right on the packaging line. Precise and consistent product handling, marking, inspection, and data gathering are required to introduce accurate data into the front end of the serialization management software. LSI has the expertise and experience to
COMPANY:
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Labeling Systems
design a complete solution from the unit, bundle, and case to the pallet level. Labeling Systems has the disciplined project management to coordinate, design, and manufacture heavy-duty pressuresensitive labeling equipment integrated with laser and ink-jet coders, vision systems, RFID technology, and data management software to deliver a successful Track and Trace solution. LSI Track and Trace system controls are based on the industry standard Rockwell Automation (Allen-Bradley) PLC platform, and the labeling and marking equipment is built to stand up to the abuses and demands of a24/7 production line.
Labeling Systems is a division of Pro Mach, a leading provider of integrated packaging products and solutions. Working with other Pro Mach brands, LSI Track and Trace systems can seamlessly interface with entire packaging and production lines.
Jack Roe, V.P. and General Manager PHONE: (201) 405-0767 LOCATION: Oakland, NJ EMAIL: jr@labelingsystems.com
COMPANY:
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The LVS 7500 offers 100% print quality inspection and barcode verification capabilities for use with Thermal Transfer Printers and other media. Built on the powerful LVS 7000 software platform, the LVS 7500 functions include master-to-label comparison (blemish detection), barcode verification (1D and 2D), barcode validation, optical character recognition (OCR), optical character verification (OCV), field matching, and number/data validation. The LVS 7500 provides a cost-effective means to identify defects, avoid liability, reduce re-work, and control waste resulting from labeling or print quality errors.
LVS is ISO 9001:2008-certified, which validates LVS commitment to all our clients and guarantees that continued improvement and compliance is achieved. KEY SERIALIZATION CONTACT
Tim Lydell, CEO PHONE: (770) 487-6414 x229 LOCATION: Peachtree City, GA EMAIL: timl@lvs-inc.com
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Laetus
The Secure Track & Trace System (S-TTS) of Laetus meets all expectations
The modular and flexible system of the German Laetus GmbH, the warrantor of high-quality security solutions, covers all known regulations for identification marks and can easily be adjusted to future specifications, such as the recently released EU directive 2011/62/EU. Whether it is necessary to fulfill requirements in Turkey, Brazil, the USA, Europe, or any other region in the world, Laetus offers an up-to-date solution. Successful worldwide pilot projects have proven that global players trust Laetus in every aspect. In addition, Laetus has repeatedly replaced less efficient solutions with its S-TTS. The powerful and highly adaptable system was developed with stringent requirements of pharmaceutical, cosmetic, and food
COMPANY: Laetus
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Laetus
productions in mind. It ensures a smooth marking and verification process from packaging to warehousing up to the point of dispensing. Laetus already realizes regimentations such as the French CIP, the E-Pedigree according to California law, or the serialization and aggregation of folded boxes as required by ITS Turkey. Secure Track & Trace can be connected to all common ERP Systems and provides a complete data transfer. The systems simple operation ensures quick and comfortable handling and reduces the potential for errors during the training process. The Secure Track & Trace software can work with a variety
COMPANY: Laetus
of printers, enhancing the systems flexibility. For example, solvent free UV colours can be applied and instantly dried with the UV DOD printer redcube offered by Laetus sister company, Hapa. Immediately thereafter, the printing is checked by a camera. To guarantee quality, the barcode can be checked throughout production according to ISO/IEC standards and ensures excellent readability in the supply chain. Laetus offers continuous software support based on Service Level Agreements. Track & Trace projects with Laetus stand for comprehensive consultation and support, long-term investment safety, and the highest process quality.
Bill Minaeff, Area Sales Manager PHONE: (973) 983-2700 LOCATION: Branchburg, NJ EMAIL: bill.minaeff@laetus.com
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Optel Vision
as EPC verification and aggregation inspections. Each PharmaProof instance can be considered a slave to a local LineMaster system where serial number observations and verifications are reported. Each PharmaProof instance tracks products on the line and controls localized hardware such as cameras, diverters and RFID readers. LineMaster: Fundamentally, the LineMaster system creates, manages and logs EPCIS Aggregation and Object event data into a local database as items are encoded, commissioned, decommissioned, destroyed, aggregated or deaggregated. At the end of each pallet or the complete packaging lot (configurable), the time stamped events are sent to the servers EPCIS repository. In addition to the above, each LineMaster can pull the process order attributes directly from the plant ERP. Attributes such as lot number;
Optel Vision ADDRESS: 2680, boul. du Parc Technologique, Qubec, Qubec G1P 4S6, Canada
PHONE: (418) 688-0334
WEB: www.optelvision.com
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Optel Vision
connected to a line level centralized point, the LineMaster, in order to distribute serial number information.
Rework Station Multiple Users using Handheld Scanner C ontrol of all Line Coders and Printers R e-insertion Zone Management Product Tracking and Ejection Turnkey Installation
EPCIS Compliant Repository Number Range Management Product Authentication Integration Services
COMPANY:
Optel Vision ADDRESS: 2680, boul. du Parc Technologique, Qubec, Qubec G1P 4S6, Canada
PHONE: (418) 688-0334
WEB: www.optelvision.com
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PharmTech
COMPANY: PharmTech
ADDRESS: 14048 Petronella Drive, Suite 201, Libertyville, IL 60048 WEB: www.PharmTechInc.com
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PharmTech
opportunities that can justify and offset the projects expense. We believe each client should receive more than just compliance from this initiative, so we build the identification of business value into our proposals.
PharmTech has been working with leading pharmaceutical manufacturers since the introduction of the California legislation and has been involved in recent projects such as:
Evaluating solutions providers Serialized data share and systems interoperability Implementing industry standards for location and product Piloting for serialized product and trades Mapping current & future state processes Long-range planning & Impact analysis Revising strategy in response to legislation and industry shifts
KEY SERIALIZATION CONTACT identification (GS1 standards)
Michael Stewart, VP Business Development PHONE: (847) 281-8924 LOCATION: Libertyville, IL EMAIL: mstewart@pharmtechinc.com
COMPANY: PharmTech
ADDRESS: 14048 Petronella Drive, Suite 201, Libertyville, IL 60048 WEB: www.PharmTechInc.com
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Seidenader
Seidenader
The Seidenader serialization solution consists of the MLS enterprise gateway software, the Process Manager line-level serialization software, and strategic line-level devices, including In-Sight smartcamera technology. MLS provides the site-level serialization gateway between your business and packaging systems. The MLS technology can ultimately manage the data flow directly with multiple enterprise connections as dictated by the overall serialization process. Such processes include: reporting interface to access typical performance metrics of line-level serialization activities. Process Manager is the primary GUI at the line level, and is responsible for managing all serialization processes, intelligent device communications, and standard equipment interfaces. Process Manager also acts as the primary vision interface for the InSight smart-camera technology. The Process Manager Vision Interface allows the end user the ability to easily configure the In-Sight camera technology, as well as make the serialization data exchange between the cameras and the Process Manager database seamless. The above suite of products is integrated together to form the overall Seidenader serialization
MLS can historically archive and make available pertinent production data required for your business, while providing a browser-based
COMPANY:
WEB: www.kmedipak.com
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Seidenader
operator audit trail, serial number reconciliation, counters, batch data, and alarms. Support for Active Directory Authentication. This security configuration provides our clientele the ability to authenticate all users and groups at the plant floor against their local Microsoft security domain. Use cases can be altered as your packaging process evolves without necessitating a reengineering of the entire serialization solution. Support for centralized palletizing and/or post-lot rework scenarios based on overall client requirements on a plant-by-plant basis. A flexible architecture designed to meet the needs of the pharmaceutical contract packaging industry at both the line and enterprise levels.
Leonard R. Valeo Sales Manager - Serialization Solutions PHONE: (609) 647-5051 LOCATION: Clearwater, FL EMAIL: valeo@kmedipak.com
COMPANY:
WEB: www.kmedipak.com
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Kevin Zarnick, Pharmaceutical Industry Manager - North America PHONE: (814) 449-2874 LOCATION: Boalsburg, PA EMAIL: kevin.zarnick@thermofisher.com
COMPANY:
Thermo Fisher Scientific ADDRESS: 127 Dearing Drive, Boalsburg, PA 16827 WEB: www.thermoscientific.com/productinspection
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Providing Labeling and Coding Solutions to the Pharmaceutical Industry for over 20 Years
Tailored Solutions for Shifting Requirements:
WLS knows that in many industries the one-size-fits-all concept does not apply. As our mission line says, through customer listening and customized thinking we have developed flexible standard platforms tailored to our customers shifting requirements. As e-pedigree compliance dates close in, WLS is uniquely qualified to work with pharmaceutical and medical device companies as a partner in their serialization and track-and-trace implementation efforts. With more than 20 years of experience in providing labeling, coding, and precision-engineered systems to the pharmaceutical and medical device industry, WLS is at the forefront of delivering customized solutions backed by a culture of unwavering customer care.
Experience with high-speed precision handling of bottles, vials, Experience with integration, installation, and service of most major
coding and vision platforms and technologies, including ink-jet, laser, and RFID
Experience interfacing to a wide range of data management software U.S.-made equipment with unsurpassed service
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Coding and inspection of unlabeled bottles, vials, cartons, etc. (bright Labeling of bottles, vials, syringes, injector pens, medical devices, etc. Serialized coding and inspection of labels prior to an existing labeling
machine with the SPS-100 print stand, or by retrofitting to a new X-4 labeling head
Coding and inspection of labels on a new WLS labeler using the new
X-4 labeling head
Concept design and prototyping Fabrication and assembly of synchronous indexing and continuousmotion platforms
Philippe Maraval, VP Sales PHONE: (847) 812-6263 LOCATION: Chicago, IL EMAIL: pmaraval@weilerls.com
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Central Repositories: SAP (Auto-ID Infrastructure AII, Object Event Repository OER) IBM (Info Sphere Traceability Server ISTS, Websphere
Sensor Events WSE)
Support of EPC Tag Data Standard for electronic product Standard interfaces: Line Controllers: Uhlmann, Seidenader, Systech International,
etc.
Independent of ERP systems and line controllers Rich product-based functionality out of the box Covering global anti-counterfeiting requirements Analysis of OEE
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PAS-X TRACK & TRACE: independent solution to ERP systems and line controllers
Manufacturing IT Business Platform is used by 16 of the worlds top 30 pharmaceutical and biotech companies in more than 600 installations. Founded in 1969, the IT company employs about 470 people at its headquarters in Lueneburg, Germany, and at nine other locations in Germany, France, Switzerland, the United States, Japan, and Singapore. KEY SERIALIZATION CONTACT
Hendrik Harms, Manager Sales & Business Consulting PHONE: +49 4131 8900-833 LOCATION: Lueneburg, Germany EMAIL: harms@werum.de
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Xyntek-Antares
Integration Analysis; Development of User Requirements and Functional Requirements Specifications; full integration from plant floor to enterprise systems; electrical and mechanical line modifications; GMP systems validation; Training, Support, and Project Management.
Xyntek-Antares
1. Experience from Production Lines
With over 270 serialization lines and over 110 full aggregation lines in production, the Xyntek-Antares Solution is based on unique experiences and lessons learned embedded into our hardware & software platforms, integration services, and project implementation procedures. This experience was gained throughout Europe. On January 1, 2012, Turkey became the first country to enforce the T&T regulations for all the pharmaceuticals sold in its territory. The Xyntek-Antares Solution fully automated over 50% of the lines in Turkey, including the largest production plant (24 full aggregation lines, operating at an average of 2 shift/day) and the largest distribution center (annual shipment of over 150M boxes/1 million cases).
2. Global Footprint
Three strategic locations in the U.S., and 18 centers in Europe offer development and operations support to countries wherever track & trace regulations emerge. Xyntek-Antares provides our clients with local and global support to enable real business change, coupled with quality technical services from cost-effective locations around the world.
3. Turnkey Services
For more than 25 years, Xyntek-Antares has provided a complete set of professional consulting and technology integration services to support the pharmaceutical industry in all phases of Serialization and e-pedigree. Including: the development of Serialization & Implementation Strategy Plans; Corporate, Site, and Line engineering assessments; Line Retrofit & Systems
COMPANY:
Xyntek, Inc. ADDRESS: 301 Oxford Valley Rd, Bldg 1402A, Yardley, PA 19067
PHONE: (215) 493-7091
WEB: www.xyntekinc.com
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Xyntek-Antares
7. Ability to Integrate from Shop Floor to the Enterprise
Our technical team has commissioned over 110 full aggregation lines to meet the various Track &Trace regulations. We have in-depth knowledge and have established business relationships with best-in-class technology vendors, including Enterprise applications, Packaging OEMs,and manufacturers of cameras, printers, and labelers. With this experience, we have the ability to integrate encoding and machine vision technology at various points of unit serialization through case and pallet aggregation, as well as integrations between the packaging lines to ERP, EPCIS, and other IT business systems.
Optional checkweighing, labeling, and tamper-evident modules. OmniVision: Bottle serialization module for bottle commissioning with optional printing of a dummy code under the bottle to facilitate bundle/case aggregation. Bundling: Various modules equipped with high-resolution cameras to read all DataMatrix codes inside the bundle/wrap; and print, apply, and verify the bundle label. Case Packing: Four modules to support manual case-packing operations by performing the reading of several DataMatrix codes at the same time. The solution minimizes any source of error that may arise from manual case packing. Palletizing: Module that enables manual aggregation of cases to pallets.
Elliot O. Abreu, Senior Vice President PHONE: (215) 493-7091 x227 LOCATION: Yardley, PA EMAIL: elliota@xyntekinc.com
COMPANY:
Xyntek, Inc. ADDRESS: 301 Oxford Valley Rd, Bldg 1402A, Yardley, PA 19067
PHONE: (215) 493-7091
WEB: www.xyntekinc.com
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Section Eight
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Serialization Glossary
Aggregation The act of assigning child-level serial numbers (such as on individual packages) to a unique serial number at the parent level (e.g., a case), thus forging an electronic association between the children and the parent. Each time goods are grouped, thats an occasion for aggregation: individual unit packages to bundles; bundles to cases; cases to pallets. Aggregation is essentially an electronic data representation of grouped physical goods. Sometimes interchangeably used with hierarchy. Regardless of what you call it, the electronic representation must always match the physical, or else bad things will happen (see discussion about inference). Certification One of the components of a pedigree, as the California Board of Pharmacy defined it. (Certification of EPCIS Electronic Product Code Transaction Authenticity. A certification Information Services. EPCIS is an under penalty of perjury from a EPCglobal standard of GS1 that responsible party of each source of a specifies a uniform way to electronically prescription drug that the information transmit between trading partners a contained in the pedigree is true and detailed representation of supply chain accurate. (B&P 4034(b).) The law events. E-pedigrees can be formed by requires that the pedigree identify the combining this information with supply individual (on behalf of each recipient) chain master data such as product, certifying delivery or receipt of a given company, location, and state of product dangerous drug, and further that the as it moves between organizational pedigree include a certification under boundaries (for example, from a penalty of perjury from a responsible pharma manufacturer to a wholesaler/ party for each source of the dangerous distributor). The pharmaceutical drug that the information contained in supply chain appears to be coalescing the pedigree is true and accurate. The around EPCIS as a way to electronically board anticipates that the required exchange e-pedigree information. certifications, of delivery or receipt, and of the truth and accuracy of the Exceptions In the world of pedigree, will be achieved by use of or serialization, an exception is an in combination with digital signatures. event that happens in the supply
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Serialization Glossary
chain that interferes with or is not part of the expected flow of goods from manufacturer to wholesaler/ distributor to pharmacy/clinic/hospital. Examples include damaged product, returns, incorrect pedigree information, etc. A working group within GS1 is currently maintaining a list of such exceptions (see pitfalls ) with an eye toward augmenting the EPCIS business vocabulary to account for them. E-pedigree An electronic pedigree (e-pedigree) refers to a record containing information as defined currently by the California State Board of Pharmacy, subject to change. For example, California law requires pedigrees to include information regarding each transaction resulting in a change of ownership, change of custody, or both, of a given prescription drug, from sale by a manufacturer, through acquisition and sale by one or more wholesalers, manufacturers, repackagers, or pharmacies, until final sale to a pharmacy or other person furnishing, administering, or dispensing the prescription drug. In some locations, a pedigree can be created in a paper-based form, but in California, pedigrees must be electronic and must be maintained in an interoperable system, ensuring compatibility throughout all stages of distribution. GLN Global Location Number is part of the GS1 System of standards. It is a simple tool used to identify a location and can identify locations uniquely where required. The GS1 Identification Key is used to identify physical locations or legal entities. The key comprises a GS1 Company Prefix, Location Reference, and Check Digit. A GLN is always 13 digits long. GTIN Global Trade Item Number. An identifier for products developed by GS1, uniquely identifying a specific product from a specific manufacturer. GTINs may be 8-, 12-, 13-, or 14-digits long. Inference Refers to the ability of a downstream trading partner to read the serial number of a case (or pallet), and infer that the individual-unit package-level serial numbers match the e-pedigree information supplied electronically by the upstream trading partner, without having to physically open the case and rescan each item.
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Serialization Glossary
Interoperability Generically, this refers to the ability of data or information created by one computer system to be read by another. In terms of serialization, it can have multiple meanings. At the level of the physical flow of packages and cases, it can mean the ability of a trading partners scanning systems to be able to scan a barcode (or RFID tag) generated by the manufacturer or contract packager. At the e-pedigree or data-sharing level, it typically refers to the ability of a trading partner to be able to read (or query) another trading partners data via a common protocoltypically EPCIS. Master data Persistent, nontransactional data that defines a business entity for which there is, or should be, an agreed upon view across the organization. Supply chain master data Persistent, non-transactional data that defines a business entity for which there is, or should be, an agreed upon view across the supply chain. Any other terms we should include? Let us know.
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Web resources
Here are some links to additional resources that you may find helpful as you start to work through your serialization plan. Applicability Statement 2 (AS2) 2015 Readiness Workshops by GS1
Regulatory
California Board of Pharmacy E-Pedigree Law website California Board of Pharmacy background and summary of CA ePedigree law
Pilot testing
U.S. Implementation Guideline: Applying GS1 Standards to U.S. Pharmaceutical Supply Chain Business Processes to Support Serialization, Pedigree and Track & Trace (Source: GS1) GS1 2015 Readiness Pilot website
Standards
GTSH Standard and Implementation Guide from GS1 GS1 Traceability White Paper EPCIS overview EPCIS Frequently Asked Questions GS1 Drug Pedigree Messaging Standard
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Links to resources
Other Resources
GS1 Healthcare US Pharmaceutical Supply Chain Open Industry Call Have we missed any important links? Let us know.
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Downloads
Although you may recall seeing some of these downloadable resources sprinkled throughout the Playbook, weve gathered them all in one convenient spot for you, no extra charge:
Download the complete results of the Healthcare Packaging survey measuring serialization readiness, and benchmark your company.
DOWNLOAD
Source: ProPharma Group, Inc.
DOWNLOAD
Source: Healthcare Packaging
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Bibliography
1. RxTrace: Consultant Dirk Rodgers made his entire blog available to us. Articles we drew from heavily include: Attributes Of A Global Track & Trace Application, Feb. 14, 2012 U.S. Pharma Supply Chain Complexity, May 23, 2011 Who Will Decide Which Pedigree Model You Will Invest In, July 30, 2012 Your GS1 Company Prefix: An Enterprise Resource, April 23, 2012 GS1 StandardsBetcha Cant Use Just One!, April 2, 2012 California Pedigree Law: Historic Change To Commerce, June 14, 2010 Pharma Serialization ROI, Jan. 3, 2011 The Surprise Consequence of the California Pedigree Law, March 5, 2012 Pharma Aggregation: How Companies Are Achieving Perfection Today, March 26, 2012 Master Data, Supply Chain Master Data and Instance Data, Sepember 30, 2009 2. Track and Trace for Pharmaceutical Industry, White Paper by Ken Fallu, Marketing Director, Optel Vision. 3. Telephone interview with Ken Fallu, Marketing Director, and Jean-Pierre Allard, Serialization Solution Manager, by David Newcorn, Healthcare Packaging, August 2012. 4. Telephone interview with Mark Feher, Mettler Toledo, by Bob Sperber, Healthcare Packaging, August 2012. 5. Telephone interview with Elliot Abreu, Senior Vice President, Xyntek, by Jim Chrzan, Healthcare Packaging, September 2012. FORWARD PLAYBOOK ADD COMMENT 6. Serialization and Track & Trace Project Management Dos & Donts, PowerPoint presentation, Mark Hallowell, Barry-Wehmiller Design Group, at Pharma Exchange, July 10-11, 2012, Chicago, an event hosted by Mettler Toledo. 7. Live Skype presentation by Virginia Herold, California Board of Pharmacy, Pharma Exchange, July 10-11, 2012, Chicago, an event hosted by Mettler Toledo. 8. Planning Serialization For Pharmaceutical manufacturers, by Gail Dutton, Life Science Leader. 9. Telephone interview with John Lewis, Cognex, by Bob Sperber, August 2012. 10. Voice of the experts: Serialization implementation challenges, by Jim Chrzan, Healthcare Packaging, August 21, 2012. 11. Retooling For Traceability: Ten Steps, White Paper by Josh Capogna, McRae Integration, and John Lewis, Cognex. 12. Telephone interview with Ron Pulincari and Kris Biernbaum, Cognex, by David Newcorn, Healthcare Packaging, August 2012. 13. Enabling Serialization Implementation, Power Point Presentation by Dave Mason, Packaging Engineering Consultant, at Pharma Exchange, July 10-11, 2012, Chicago. 14. Telephone interview, David Mason, Packaging Engineering Consultant, by David Newcorn, Healthcare Packaging, August 2012. 15. The news behind the news: Global serialization, by Jim Chrzan, Healthcare Packaging, September 7, 2012. 16. A Guide To Pharmaceutical Serialization, by Gunter Schilpp, Life Science Leader. 17. Serialization need not be complex, by Jim Chrzan, Healthcare Packaging, July 11, 2012. BACK TO CONTENTS
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Bibliography
18. Serialization urgency: Industry has failed to sound the alarm by Jim Chrzan, Healthcare Packaging, July 12, 2012. 19. Deploying Serialization and Track & Trace in the Global Regulatory Environment, PowerPoint presentation by Bill Fletcher, Managing Partner, Pharma Logic Solutions, LLC, at Pharma Exchange, July 10-11, 2012, Chicago. 20. A Guide to Pharmaceutical SerializationChoosing the Right Equipment Supplier, White Paper by Mettler Toledo. 21. Serialization: How Will You Track Every Item?, Siemens Totally Integrated Automation, July 3, 2012. 22. Telephone interview with Len Valeo, Sales Manager - Serialization Solutions, Seidenader (Krber Medipak), by David Newcorn, Healthcare Packaging, September 2012. 23. Written responses to questions from Healthcare Packaging, October 2012, by Len Valeo, Sales Manager - Serialization Solutions, Seidenader (Krber Medipak). 24. Written responses to telephone interview questions provided to Healthcare Packaging, September 2012, by John DiPalo, COO, Acsis. 25. Pilot Report: Lessons Learned About Serialization and Pedigree Using GS1 Standards, GS1 US Healthcare. 26. Telephone interview with Almac Pharma Services serialization team (Pauline Glenholmes, Business Projects Manager; Sean Mulholland, Senior Quality Compliance Officer; David Downey, VP Commercial Operations; Geoff Sloan, VP Manufacturing Operations), by David Newcorn, Healthcare Packaging, September 2012. 27. Written responses to telephone interview questions provided to Healthcare Packaging by Almac Pharma Services. 28. Global pharma packager plants flag in U.S. soil, Contract Packaging, September 2012. 29. Written responses to telephone interview questions provided to Healthcare Packaging, September 2012, by Stephen McIndoe, Vice President, Consulting, Be4ward. 30. Written responses to telephone interview questions provided to Healthcare Packaging, September 2012, by Michael Stewart, Strategic Business Planning, Track & Trace Projects, PharmTech, Inc. 31. California 2015 Serialization & e-pedigree: Strategic Planning, White Paper by Michael Stewart, Strategic Business Planning, Track & Trace Projects, PharmTech, Inc., June 2012. 32. GS1 Track and Trace standards and implementation, PowerPoint presentation by Bob Celeste, Director, GS1 US Healthcare, at Pharma Exchange, July 10-11, 2012, Chicago. 33. Telephone interview with Bob Celeste, Director, GS1 US Healthcare, by David Newcorn, Healthcare Packaging, September 2012. 34. Healthcare Supply Chain Traceability, White Paper by GS1, October 2010. 35. Telephone interview with Greg Cathcart, CEO, Excellis Healthcare, by David Newcorn, Healthcare Packaging, September 2012. 36. Telephone interview with Shabbir Dahod, President/CEO Tracelink, by David Newcorn, Healthcare Packaging, September 2012. 37. Telephone interview with Neville Nol and Benoit David, Endeavor Consulting Group, by David Newcorn, Healthcare Packaging, September 2012. 38. Verification and Vision System Considerations, by Jean-Pierre Allard, Serialization Solution Manager, Optel Vision, Packaging Machinery Technology, September/October 2012.
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Bibliography
39. Laser Coding for Serialization PowerPoint presentation by Mark Shaffer, Pharmaceutical Business Development Manager, Domino, at Pharma Exchange, July 10-11, 2012, Chicago. 40. Printing and Coding Requirements, by Bill Bonaccorsi, Director of Marketing, Domino, in PMT Magazine, September/October 2012. 41. Telephone interview with Omega Designs Glenn Siegle, President; Randy Casperson, VP/Marketing; Len Dubee, Director of Manufacturing; and Chris Siegle, by David Newcorn, Healthcare Packaging, August 2012. 42. Coding and Marking in the Pharmaceutical Industry, PowerPoint presentation by Chris Riley, Business Unit Manager, Videojet Technologies Inc., at Pharma Exchange, July 10-11, 2012, Chicago. 43. Telephone interview with Chris Riley, Business Unit Manager, Videojet Technologies Inc., by David Newcorn, Healthcare Packaging, August 2012. 44. Telephone interview with Rich Bahr, President, MGS Machine, by Bob Sperber, Healthcare Packaging, August 2012. 45. Pfizer and TraceLink: Track and Trace / Serialization Pilot Insights, Webinar, April 2012, featuring Peggy Staver, Director of Product Integrity, Pfizer; and Barry Sommerville, Director of Global Market Logistics IT, Pfizer. 46. Global Trade Item Number definition, Wikipedia. 47. Healthcare Packaging Survey of 108 pharmaceutical companies, SeptemberOctober 2012. 48. Master data entry, Wikipedia. 49. GLN definition from Wikipedia. 50. California Board of Pharmacy Q&A document. 51. Study Proves RFID Technology Safe for Use with Biologics, Yahoo! Finance, July 25, 2012. 52. Researchers find Biologics Not Harmed by RFID RF Signals, RFID Journal, March 25, 2011. 53. Research shows RFID is safe to use with biologics, RFID24-7, July 30, 2012.
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