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OVERVIEW
• Founded in 2006
• Headquarter in Mannheim (Germany)
• 15 offices across 3 continents (NA, Europe, Asia)
Digital Manufacturing
• Collaborative partner with SAP:
Since 2000
• SAP Software Solution and Technology Partner
Track & Trace
• SAP Services Partner
Since 2006
• SAP Consulting Partner
Mobile Solutions Cloud Solutions
• SAP User Since 2016
Since 2006
Warehouse Logistics
THE MOST SPECIALIZED PARTNER
FOR T&T AND THE MOST
COMPLETE T&T OFFERING
Movilitas Summary of Services Movilitas Areas of Services
▪ Stakeholder Management (Solutions Portfolio)
▪ Program Management
▪ SAP Track & Trace (ATTP, AII/OER, GTT)
▪ Project Management
▪ Requirements Gathering ▪ SAP GBT
▪ Blueprinting and Design ▪ Movilitas.Cloud and Mobile for T&T
▪ Implementation and Development ▪ Resourcing for T&T Experts
▪ Testing and Go-Live support
▪ Supply Chain Integrity
▪ Change management
▪ Training delivery
▪ Ongoing Support for operation of the
systems
▪ Support in QA/Validation
Movilitas
T&T Key Facts
▪ Movilitas has delivered (or is currently delivering) 65+ Serialization and Track & Trace projects since 2007
▪ Furthermore Movilitas has integrated it’s Track & Trace solutions (e.g. Movilitas.Cloud, SAP ATTP) system with various different partners.
▪ Movilitas has a broad range of SAP based as well as own developed solutions
▪ Movilitas is able to demonstrate today(!) full end to end serialization across all levels incl reporting functionality
▪ Movilitas has approx. 60 SAP Serialization and Track & Trace Solution consultants doing only and exclusively Serialization and Track &
Trace projects.
▪ This quantity and quality of expertise and resources is globally unique (even large integrators contract us!)
The introduction of wide ranging serialisation regulation by the Russian authorities will
pose significant challenges to all pharmaceutical companies who supply product to the
Russian Federation.
The Regulation
A quick look
Pharmaceutical Serialization Requirements in Russia
The Regulatory framework
The relevant decrees have all been passed by the Russian Parliament.
December: Federal law 61-03 (amended 425-03), introduces obligatory use of Data Matrices from 1/1/20
Order 2828 Dec 18th 2018, confirms CRPT as the permanent operator of the state MDLP reporting system
Decree 1556, Dec 14th 2018, defines the information to be included in the Datamatrix as well as defining the
basic reporting principles and requirements
There are some other related decrees, 1557, related to specific drugs (nosologies)
Pharmaceutical Serialization Requirements in Russia
The Timeline
The timelines are set and known
….. And highly aggressive
Coding/labelling
Impacts
Implications
Pharmaceutical Serialization Requirements in Russia
Implications
The Russian model is a full track and trace model; it is comprehensive and affects labelling, bar coding and
introduces serialization, aggregation and reporting requirements, including a unique concept; that of
applying a cryptographic signature to each GTIN/serial number combination. The impacts are therefore
pervasive:
▪ The packaging lines are impacted,
▪ The regulatory reporting requirements are extensive with potentially significant cost ramifications on
logistics operations,
▪ Due to the crypto-graphic requirement, there are key architectural design decisions to be made in the
manufacturing space, affecting the packaging lines and level 4 systems, especially for companies with
established serialisation systems for existing markets,
▪ CMO operations are impacted, again with potentially significant cost implications.
Due to the impacts on the manufacturing processes as well as the logistics processes anyone supplying
to the Russian market needs to put in place quickly a number of concurrent analysis activities directed to
provide appropriate stakeholders with the information they need to make informed decisions
Pharmaceutical Serialization Requirements in Russia
Implications - Manufacturing
That’s one problem – but ACQUIRING the cryptos introduces new issues
So let’s have a look at the basics and what the implications of obtaining the cryptos might
be
And lets not forget that there may be a charge for the cryptos (as yet unspecified)
Accessible from L4 or L3
Crypto-graphic protection of the data
matrix bar code (digital signing of each
The “gateway API” is accessible from a level 3 or 4 system, from
specific data matrix) a custom built middleware if necessary (or indeed from a L5)
Gateway Hardware
API crypto server
Decision Point: L3 or L4 access to crypto-service
(Or L5)
Pharmaceutical Serialization Requirements in Russia
Implications - Manufacturing
Accessible from L4 or L3
Crypto-graphic protection of the data
matrix bar code (digital signing of each
specific data matrix)
Level 4 access to crypto service
Level 4 system requests the cryptos from the service, must
Cloud based
store and manage the crypto-serial pairs, distribute them to the
Crypto server lines as required (thus the line interfaces must change) and
report consumption to the crypto-service
Accessible from L4 or L3
Crypto-graphic protection of the data
matrix bar code (digital signing of each
If you have multiple line suppliers and multiple lines affected,
specific data matrix) then the level 4 system will be the logical system to request and
store the crypto-codes, and then hand them down to the level 3
systems with the serial numbers
Cloud based
Crypto server
If you can localise the lines and sites impacted, then there is a
serious case to use an L3 solution, BUT the necessity for
involving enterprise security to access external Russian services
from automation networks is something most Line suppliers will
Level 3 or 4 not have experienced before. Access to external entities will be
assessed and managed by the enterprise teams.
Gateway Hardware
API crypto server
Software version management will come into play as well. If
you have lines from supplier A which supply to Russia and lines
from Supplier A which don’t, either you have two interface
versions or you have significant regression testing
Pharmaceutical Serialization Requirements in Russia
Implications - Manufacturing
Accessible from L4 or L3
ATTP If you an SAP user and are using ATTP, then your only credible
option is to take the SAP FP for Russia, any custom
Lines development would be far too extensive and expensive, and far
too risky.
Russian specific serialisation implementation
[I do not believe there is an SAP option for OER/AII users]
Accessible from L5
CMOs
And …
2. The MaH may acquire the crypto-codes, distribute them to the CMO, and report
consumption (311)
3. The CMO may acquire the crypto-codes and report crypto consumption (311)
Depending on location
Pharmaceutical Serialization Requirements in Russia
Implications - CMOs
Crypto-service MDLP
Pharmaceutical Serialization Requirements in Russia
Implications - CMOs
Crypto-service MDLP
Pharmaceutical Serialization Requirements in Russia
Implications - CMOs
Crypto-service MDLP
Pharmaceutical Serialization Requirements in Russia
Implications - CMOs
Crypto-service MDLP
Pharmaceutical Serialization Requirements in Russia
Implications - Logistics
MDLP
MDLP
311 321 915 331 415 416
332 312 335 341
Usage Foreign Multi Foreign Move receive
Foreign Control FTS data receive
confirmation emission pack shipment order order
import samples importer
552 431 541/2 811 250 551 251/605 252/606 911 912 913 914 915 441 210
withdrawal Move place destruction relabelling recall Re-export Refusal Refusal Unit Unit Unit Unit Multi Move Query
sender receiver pack unpack extract append pack Unregistered SGTIN info
order
▪ All movements to the packaging hierarchies have to reported – this
means all typical serialised scanning operations (pack, unpack, sampling, Typical serialized scanning
destructions, etc
552 431 541/2 811 250 551 251/605 252/606 911 912 913 914 915 441 210
withdrawal Move place destruction relabelling recall Re-export Refusal Refusal Unit Unit Unit Unit Multi Move Query
sender receiver pack unpack extract append pack Unregistered SGTIN info
order
552 431 541/2 811 250 551 251/605 252/606 911 912 913 914 915 441 210
withdrawal Move place destruction relabelling recall Re-export Refusal Refusal Unit Unit Unit Unit Multi Move Query
sender receiver pack unpack extract append pack Unregistered SGTIN info
order
To summarise
impact impact
middleware impact
impact
Lines Level 4 Warehousing
ATTP or similar
impact
MDLP
Line systems
ERPs
impact
CMOs impact
Pharmaceutical Serialization Requirements in Russia
Critical
Considerations
Pharmaceutical Serialization Requirements in Russia
Critical considerations
… at programme initiation
1) There are a number of working groups that need to be set up to carry out the
necessary evaluations, make recommendations, assess impacts and risks
2) These evaluations need to be initiated quickly and in parallel, there are significant
decisions needed quickly and there are very considerable cost implications
3) These must feed into the programme steering or governance and result in
recommendations being submitted to the business stakeholders
Pharmaceutical Serialization Requirements in Russia
Critical considerations
PMO
Costs, risks, change, etc
Pharmaceutical Serialization Requirements in Russia
Critical considerations
Needs to provide clear set of recommendations across entire serialisation environment, options considered, options
discounted, design risks, impacts on all affected systems summarised, strategy
Working group needed to assess impacts on printing, and in particular whether the data
matrices can be printed/read to appropriate quality standards. MaHs will need full
impact cost assessments from suppliers as well as clear timelines for implementation.
Working assumption here is that you need to treat the line solution as a “black box”,
solely responsible for acquiring and managing the serial/crypto pairs, and that this black
box can meet the crypto/serial reporting (311) consumption confirmation.
[BUT there remains the question of what do you do if you need to reprint the labels in
the warehouse? How does the warehousing system obtain new serials and associate
cryptos? Is it licensed to do so? Or do you simply “write off” in the warehouse?]
But if you can keep it simple and localise impact to one line supplier, minimal number
of sites, then L3 solution could be the cheapest initial solution. But only “IF”
Pharmaceutical Serialization Requirements in Russia
Critical considerations
MDLP reporting and Warehousing does NOT scale well for Russia
The more warehouses involved in receiving , shipping and distributing product for Russia, the more complex it becomes, its more of a “J”
curve than a simple linear increase of complexity.
At the simple end of the spectrum: if for example you have 1 warehouse in Russia and 1 warehouse operator – it can be relatively simple,
get the Russian warehouse operator to do the MDLP reporting
At the complex end of the spectrum: if you have multiple warehouses all shipping to Russia, and they have significant warehouse
movements between batch release and shipping, with complex shipping routes and you have external warehouse operators in Russia –
reporting and reconciliation, maintaining integrity across multiple warehouses, the reporting system and the MDLP escalates into being
potentially hugely complicated
The more you can simplify and reduce the number of involved logistics nodes, especially logistics nodes that impact hierarchies, the
easier and cheaper it will be
Pharmaceutical Serialization Requirements in Russia
Critical considerations
Source shipping warehouse Customs bonded warehouse Russia Distribution warehouse Russia
Pharmaceutical Serialization Requirements in Russia
Critical considerations
MaH Source shipping warehouse Customs bonded warehouse Russia Distribution warehouse Russia
Pharmaceutical Serialization Requirements in Russia
Critical considerations
Source shipping warehouse Customs bonded warehouse Russia Distribution warehouse Russia
Pharmaceutical Serialization Requirements in Russia
Critical Considerations
1. MaH is responsible for MDLP reporting, CMOs may request the crypto-
codes on behalf of the MaH and report the commissioning (via 311)
2. Clear definition of responsibilities for CMOs defined and agreed
3. Data, interface and reporting specified and agreed
4. Reporting obligations a matter of contractual necessity
5. Existing and potentially new commercial and production strategies
should be assessed and the reporting requirements around crypto-
CMO working group confirmation agreed
6. Timelines and costs on options to be assessed and quantified
Pharmaceutical Serialization Requirements in Russia
Critical Considerations
Outsourcing and A key decision is “what system” is going to be responsible for the MDLP
partnerships reporting? Which “node” in the logistics chain is the “cheapest”, i.e. reporting
from “where” has the least impact?
For organisations with complex logistics set-ups, using Russian operators who
can offer MDLP reporting services, warehousing services may be a serious
consideration, exchanging capital development costs for recurring annual
operational costs may be an expedient option, either initially or longer term.
Pharmaceutical Serialization Requirements in Russia
Critical Considerations
SAP considerations
Connectivity Options planned for mid 2019
▪ Direct Connection
o ATTP* provides the capabilities to generate most of the required messages for
file exchange. Events will be stored on a customer file share to be uploaded
manually to RU Government system with FP2
o Connection is planned with ATTP 2.4
▪ Gateway Connection
o SAP plans the gateway option to connect to the RU Government system
depending on the specific requirements in Russia – similar to EU
Boundary Conditions
▪ Both options require the RU Country Pack for ATTP.
▪ ATTP provides readily formatted messages through the RU country package. ICH does
not perform mapping for regulatory reporting messages.
▪ 1.SAP is in alignment with customers for deeper process integration into ERP processes and documents.
▪ 2. SAP to release soon updated interface specification for russian exchange scenarios: SNRequest/Response and Business
Partner connection.
Pharmaceutical Serialization Requirements in Russia
Critical Considerations
Conclusions
For all but the simplest serialisation setups, supplying the Russian market presents very significant
challenges:
▪ Impact on lines
▪ Impact on manufacturing processes and systems
▪ Impact on logistics processes and systems
▪ Impact upon partners
Questions
Pharmaceutical Serialization Requirements in Russia
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