SERIALIZATION –

CHALLENGES AND GOOD

PRACTICES IN PACKAGING
OPERATIONS BASED ON
EXPERIENCE OF TRACK AND
TRACE SYSTEMS

CONNECT
COLLABORATE
ACCELERATE TM

Serialization – challenges and good practices in packaging

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operations based on experience of track and trace systems
Contents
Contents............................................................................................................................................................................................................. 2

1.0 Introduction and background......................................................................................................................................................... 6

2.0 Glossary................................................................................................................................................................................................ 9

3.0 Track and trace, and OEE system performance .......................................................................................................................10

3.1 Considerations for reducing the impact of serialization and aggregation on OEE and system performance... 11

3.1.1 Choosing equipment ................................................................................................................................................................12

3.1.2 Process equipment flow .........................................................................................................................................................13

3.1.3 Manual operations and OEE..................................................................................................................................................14

3.1.4 Aggregation for optimal OEE and system performance..............................................................................................14

3.1.5 Considerations for system design for serialization and aggregation......................................................................18

3.1.6 Considerations for deviation management for serialization and aggregation....................................................18

3.1.7 Using serialization OEE data management for continuous improvement ...........................................................19

4.0 Serialization technology limitations in the pharmaceutical industry ................................................................................21

4.1 Software and hardware components of T&T systems....................................................................................................... 21

4.2 Implementation of new technologies..................................................................................................................................... 22

4.3 Variable market requirements................................................................................................................................................. 22

4.4 Standardization – the way forward......................................................................................................................................... 23

5.0 Decommissioning of serial numbers ...........................................................................................................................................24

5.2 100% reconciliation options and challenges......................................................................................................................... 24

5.3 Aggregation vs manual reconciliation as a solution for decommissioning.................................................................. 25

6.0 Training for serialization ...............................................................................................................................................................26

6.1 The need for specialized training on serialization............................................................................................................... 26

6.2 Training with L1–L5 systems .................................................................................................................................................... 27

6.3 L3 system – site-level support................................................................................................................................................... 28

6.4 L1/L2 system – Training activities on the line...................................................................................................................... 28

6.5 Exam and certification................................................................................................................................................................. 28

6.6 Dedicated training facilities/lines ........................................................................................................................................... 29

References.......................................................................................................................................................................................................30

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List of tables
Table 1: Serialization requirements overview of major markets (as of April 2021)3................................................................................................................................................................................ 8

Table 2: High-level print technology comparison and the impact on OEE ................................................................................................................................................................................................ 12

Table 3: Aggregation equipment changes and the potential impact on OEE............................................................................................................................................................................................ 14

List of figures
Figure 1: Serialization and aggregation packaging steps...................................................................................................................................................................................................................................... 7

Figure 2: OEE definitions................................................................................................................................................................................................................................................................................................. 10

Figure 3: Recommended typical serialization process flow on item level................................................................................................................................................................................................... 13

Figure 4: Recommended typical automated case packing aggregation flow sales unit to shipper case ....................................................................................................................................... 15

Figure 5: Recommended typical semi-automated aggregation flow sales unit to shipper case........................................................................................................................................................ 16

Figure 6: Recommended typical automated bundling aggregation flow sales units to bundle.......................................................................................................................................................... 17

Figure 7: Recommended typical aggregation of shipper cases to pallet (manual option).................................................................................................................................................................... 18

Figure 8: L1–L5 serialization system levels............................................................................................................................................................................................................................................................. 26

Figure 9: Example from a major pharmaceutical company’s internal SOP describing how local and global roles and responsibilities correspond to the
L1–L5 system and required training........................................................................................................................................................................................................................................................................... 27

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Authors
Janssen Roche
Fernandito Arroyo Bartosz Urbaniak
Pfizer Takeda
Ivor Kesic Michael Ritter

Contributors and reviewers

Fujifilm Diosynth Biotechnologies Novo Nordisk
Bente Post-Pedersen Steen Christiansen
Ferring Takeda
Ludovic Bennoit-Gonni Antonio Burazer
CSL Behring UCB
Warren Comerford Nicola Maggi
Sebastien Langlois-Berthelot
BioPhorum
Eli Lilly Scott Ewan
Robert Stapleton Jannika Kremer

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About BioPhorum
BioPhorum’s mission is to create
environments where the global
biopharmaceutical industry can collaborate
and accelerate its rate of progress, for the
benefit of all.
Since its inception in 2004, BioPhorum has become the
open and trusted environment where senior leaders of
the biopharmaceutical industry come together to openly
share and discuss the emerging trends and challenges
facing their industry.
Growing from an end-user group in 2008, BioPhorum now comprises over
110 manufacturers and suppliers deploying their top 5,000 leaders and subject
matter experts to work in eight focused Phorums, articulating the industry’s
technology roadmap, defining the supply partner practices of the future, and
developing and adopting best practices in drug substance, fill finish, process
development and manufacturing IT. In each of these Phorums, BioPhorum
facilitators bring leaders together to create future visions, mobilize teams of
experts on the opportunities, create partnerships that enable change and provide
the quickest route to implementation, so that the industry shares, learns and builds
the best solutions together.

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1.0
Introduction and background
According to World Health Organization (WHO) definitions, track and
trace (T&T) is a type of traceability model that attempts to track and
trace products through a supply chain. ‘Track’ is the ability to know
where a product is right now, and ‘trace’ is the ability to know where a
product has been within a supply chain prior to its current location.
The capability to trace something is, in some cases, interpreted as the
ability to verify the history, location or application of an item by means
of documented recorded identification.
To provide necessary functionality, each pack must be marked with a unique product
identifier (UPI) during packaging operations. Serialization is the process of defining,
assigning and affixing UPIs or unique serial numbers to product packaging at any level
to enable products to be traced through a supply chain. UPIs consist of a combination of
numbers (e.g. global trade identification number (GTIN), serial number (SN), batch number
and expiry date), unique to each pack. Serialized packs are often aggregated to shipping
containers and pallets to further enhance T&T. Aggregation is the documented parent/
child relationship between uniquely identified items and the uniquely identified outer
containers that they are contained within, used for the purposes of improving the efficiency
of serialization business processes involving data exchange and/or regulatory requirements.
Serial numbers are entered into a digital repository at the time of packaging and follow
products through the supply chain. Before a drug is sold or administered to the patient, its
authenticity can be checked by scanning the UPI and comparing the encoded values with
those stored in the national database1.

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Figure 1: Serialization and aggregation packaging steps

Unit-level pack Bundle pack Case Pallet

serialization aggregation aggregation aggregation

T&T of pharmaceutical products through the supply chain industry still faces a number of technical challenges and
has become a common health authority requirement, dating limitations relating to regulatory expectations, with
back to Turkey in 2010 (see Table 1), even if not yet globally many pharmaceutical companies around the world still
standardized. Regulations around this topic are needed to transforming their packaging operations to meet them.
ensure that systems are in place to determine the authenticity
In response to these challenges, the BioPhorum Secondary
of medicines and to improve distribution compliance.
Packaging Team completed an industry benchmark on
An important benefit of T&T systems is to make counterfeiting
the serialization of sellable units. The purpose of this
harder. According to WHO estimates, counterfeiting of
benchmark was to identify common industry challenges with
medicines is responsible for one million deaths annually and
serialization and to broaden the knowledge of good practice,
10% of all drugs sold globally are fake. Global events such
industry capabilities and to identify the quickest route to
as the COVID-19 pandemic further increase these risks by
implementation and compliance with global serialization
disrupting the supply chain and increasing internet purchases2.
requirements (see Table 1). The benchmark was completed
The introduction of T&T regulations has driven specific in 2020 by 11 pharmaceutical companies and covered the
changes to industry packaging practices. Digital information following topics: governance, training, grading of print, overall
related to the drug has become a major quality-relevant part equipment effectiveness (OEE), decommissioning of serial
of the drug packaging process. UPIs must be applied, verified numbers, technology limitations, primary unit serialization
and transported together with the medicines. Any data and non-standard requirements.
discrepancies between the manufacturing and dispensing
The results of the benchmark survey were reviewed by the
of the drug will result in the product being suspected a
11 participating companies together with the additional
counterfeit and will lead to detailed investigation.
pharmaceutical companies in the BioPhorum Secondary
This paradigm shift has triggered considerable modifications
Packaging Team. This paper provides an overview of
to drug packaging processes and technologies. While
points to consider and good practices relating to the most
the purpose of most T&T regulations is primarily to fight
challenging areas identified during two workshops, in May
counterfeiting, additional uses, such as the fight against
2020 and in December 2020. The four most challenging
tax fraud or use for custom controls, introduce additional
areas discussed within the scope of this paper are: OEE and
non-related requirements that often do not follow
system performance; technical limitations; decommissioning
international standards. These non-standard requirements
of serial numbers; and training. This paper seeks to encourage
influence the technical requirements and established
dialogue between industry, regulatory agencies and T&T
processes in pharmaceutical operations, adding additional
system providers, by adding the unique perspective of the
complexity and challenges to the implementation and use
secondary packaging customer, summarized after several
of serialization on packaging lines. More than 10 years after
years of using such serialization systems.
the first introduction of serialization, the pharmaceutical

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Table 1: Serialization requirements overview of major markets (as of April 2021)3

Market/requirement Scope/traceability model Legislation Serialization requirements

enforcement

Argentina Full track and trace 2013 GS1 standards endorsed

Bahrain Full track and trace 2021 GS1 standards endorsed

Brazil Full track and trace 2022 GS1 standards endorsed (with ANVISA registry number to be encoded in the
DataMatrix in addition to GTIN)

China Full track and trace 2019 Revised regulation now endorses ISO-compliant standards (including GS1)
beside existing China e-code system

Ecuador Full track and trace 2021 (phased GS1 standards endorsed
approach)

EU – Falsified Point of dispense verification 2019 GS1 standards endorsed (with few countries requiring National Health
Medicines Directive Reimbursement Number to be encoded in the DataMatrix in addition to GTIN)

India – DGFT Full track and trace 2016 GS1 standards endorsed
requirements (export)

Indonesia Full track and trace 2021 (phased GS1 standards endorsed for prescription medicines (authentication)
approach)

Russia Full track and trace 2019–20 Unique crypto key and crypto code issued by Russian agency must be encoded
in the DataMatrix

Saudi Arabia Full track and trace 2020 GS1 standards endorsed

South Korea Full track and trace 2015 GS1 standards endorsed (with Korea Drug Code embedded in the GTIN)
(with optional aggregation)

Turkey Full track and trace 2010 GS1 standards endorsed

US – Drug Supply Chain Full track and trace 2018–23 GS1 standards endorsed (with US National Drug Code embedded in the GTIN)
Security Act (DSCSA) (phased
approach)

Key takeaways
•  he introduction of T&T regulations has driven specific changes to industry packaging practices. Digital
T
information related to drugs has become a major quality-relevant part of the drug packaging process. This
paradigm shift has triggered considerable modifications to drug packaging processes and technologies.
•  ore than ten years after the introduction of serialization, the pharmaceutical industry still faces a number
M
of technical challenges and limitations relating to regulatory expectations, with many pharmaceutical
companies around the world still transforming their packaging operations to meet them.
•  he top four challenging topics/processes related to serialization discussed in this paper are: OEE and
T
system performance; technical limitations; decommissioning of serial numbers; and training.

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2.0
Glossary
Aggregation – The documented parent/child
relationship between uniquely identified items and
the uniquely identified outer container that they are
contained within for the purposes of improving the
efficiency of serialization business processes involving
data exchange and/or regulatory requirements.
Decommissioning – The act of documenting the
disassociation of a unique identifier from a specific
instance of an object class, typically when the object no
longer exists or reaches the absolute end of its life cycle
(i.e. after destruction or consumption of a product).
GAMP® 5 – Good automated manufacturing
practice version 5; usually, the term GAMP® 5 is
used in reference to a guidance document entitled
GAMP® 5: A Risk-Based Approach to Compliant
GxP Computerized Systems, which is a system for
producing quality equipment using the concept of
prospective validation following a life cycle model.
Global trade item number (GTIN) – is the 14-digit
GS1 identification key used to identify products. The
key comprises a GS1 company prefix followed by an
item reference number and a check digit.
Grading – The process of qualifying a printed code.
Printed codes used for serializing pharmaceutical
products are graded according to eight different
parameters under the ISO 15415 standard.
GS1 – GS1 is a non-profit standards organization
that develop standards-based solutions to address
the challenges of data exchange.
Packaging levels – The hierarchy of product
packaging; each level includes a specific way of
protecting and identifying the product during
different types of handling. Recognized levels
include ‘primary’, ‘secondary’ and ‘tertiary’.
©BioPhorum Operations Group Ltd | September 2021
Point of dispense model – One of two track and trace
models currently used on the global market. In this model,
prior to dispensation in pharmacies or healthcare centers,
the serial code on the package of medical products is
validated by comparing it with the code provided by the
product registration holder4.
Reconciliation – A fundamental process step in the
pharmaceutical finished goods packaging process that
ensures all regulatory requirements for distribution and
sale of a medicine are met. Serialization reconciliation
ensures that serial numbers are used correctly for
finished products with traceability in each phase of the
pharmaceutical packaging process, beginning with the
generation of serial numbers, and ending with the supply
of serialized, finished goods to the market.
Serialization – The processes for, and results of, defining,
assigning and affixing unique serial numbers to product
packaging at any level.
Serial shipper container code (SSCC) – The GS1
identification key used to identify a logistic unit.
This unique identifier is comprised of an extension digit, a
GS1 company prefix, a serial reference and a check digit.
Trace – The ability to know where a product has been
within a supply chain prior to its current location.
Traceability – The capability to trace something. In some
cases, it is interpreted as the ability to verify the history,
location or application of an item by means of documented
recorded identification.
Track – The ability to know where a product is at any
given moment.
Track and trace (T&T) – 1. A type of traceability model
that attempts to track and trace products through a supply
chain. 2. (Colloquial) A term used to refer to any and all
traceability models.
Unique product identifier (UPI) – A unique serial number
in combination with a product code. A unique identifier
identifies a single instance of a product.
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3.0
Track and trace, and OEE
system performance
The OEE measurement is key to ensure equipment, in this case secondary packaging equipment, is performing well.
The OEE measurement supports continuous improvement initiatives within a company’s manufacturing network.
When used correctly, it allows a company to optimize capacity usage prior to any investment to bridge capacity
gaps. There are different OEE solution providers and different ways OEE can be interpreted, but essentially OEE
is calculated as described in Figure 2 and expressed as a percentage that identifies the manufacturing time that is
truly productive. Of the different levels of OEE, Level 2 is the most commonly used in the pharmaceutical industry.

Figure 2: OEE definitions

Max operating time

Actual operating time No demand

Unplanned Planned Test and

Actual run time Setup
downtime downtime validation

Theoretical
Quality loss Speed loss
run time

Theoretical run time (1)

OEE 3 =
Actual operating time – Test and validation — Planned downtime

Theoretical run time

OEE 2* =
Actual operating time – Test and validation

Theoretical run time

OEE 2 =
Actual operating time

Theoretical run time

OEE 1 =
Max operating time

Produced quantity
(1) Theoretical run time =
Theoretical speed

Maximum validated speed of the bottleneck

Theoretical speed =
equipment of the line for a particular product (group)

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Before the introduction of serialization, secondary
packaging practices were well standardized across the
industry. Depending on the stock keeping unit (SKU) mix,
and the number of changeovers required to satisfy the
different requirements of varying market demands, the
OEE for a standard packaging process commonly achieved
levels of around 39%. However, higher OEE levels of
around 70–75% could reasonably have been expected in a
best-case scenario where a packaging line is dedicated for
a particular SKU. Many pharmaceutical manufacturers are
concerned about the potential negative impact of installing
serialization equipment on the packaging line OEE. A
recent survey of pharmaceutical companies who have
installed serialization and T&T systems, reported as much
as a 30% drop in OEE levels5.
3.1 Considerations for reducing
the impact of serialization
and aggregation on OEE
and system performance
Serialization requires upgraded packaging lines and a
good understanding of the T&T trade partner integration.
Upgrading lines includes careful consideration of market-
specific requirements because it impacts on equipment
needs (e.g. printers and aggregation machines). It is useful
©BioPhorum Operations Group Ltd | September 2021
to consider two main implementation scenarios when
deploying serialization on a pharmaceutical packaging line.
These require different levels of attention, but a similar
degree of standardization with respect to equipment,
validation and project management:
•  cenario 1: Installation of serialization and/
S
or aggregation equipment into a brand-new
packaging line
•  cenario 2: Installation of serialization and/
S
or aggregation equipment into an already-
operational packaging line.
The authors of this paper consider scenario 1 to be the
ideal scenario because serialization and/or aggregation
requirements can be considered in the machine design
from the outset. However, although raising more
challenges than scenario 1, scenario 2 is more common.
Technical challenges arising from scenario 2, which could
impact negatively on the OEE, are:
• Line stoppages caused by sub-optimal
serialization process, e.g. due to space constraints
or outdated equipment
•  ackaging line speed and space limitations
P
caused by print technology
•  eject rates, e.g. caused by online inspection and
R
grading of all printed codes (as per ISO 15415)6.
Serialization – challenges and good practices in packaging
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3.1.1 Choosing equipment consideration when choosing equipment is that artwork
requirements differ depending on the selected print
When choosing equipment for serialization, one needs to
technology. There are several factors to consider when
consider print equipment for item serialization, inspect on
choosing between the two major print technologies
sales unit and aggregation equipment. When introducing
available: laser and inkjet. Table 2 gives a summary of
serialization equipment into an existing packaging line
these factors and their potential impact on OEE. It should
(scenario 2), there may be limited options depending on
be noted that there are other aspects to consider than
the footprint of the packaging line. Another important
OEE when choosing print technology.

Table 2: High-level print technology comparison and the impact on OEE

Factors Laser Inkjet Potential impact on OEE

Expenditures, print quality, light resistance, No impact No impact No major/significant impact on OEE.
print quality human readable

Space/installation No impact No impact No major/significant impact on OEE.

Laser usually requires more space.

Dust - + Laser causes dust, due to ablation of the paint or varnish from
the material, which could cause the line to stop more often for
cleaning. Alternatively, it requires installation of a dust-extraction
system, which impacts the need for available space.

Cardboard requirements - + Laser requires more sensitive and constant cardboard quality (high
kaolin content) to ensure good print quality and low reject rate.

Line speed - + Inkjet allows higher speed of the conveyor belt (> 40m/min).

Maintenance needs + - Laser is generally more stable in terms of performance while inkjet
requires more maintenance (i.e. replacing the ink cartridges).

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3.1.2 Process equipment flow take place as late as possible in the packaging process to
avoid data integrity issues, e.g. a commissioned carton
When implementing T&T on a new or existing line it is
is rejected by a reject mechanism or taken out of the
important to consider process equipment flow. A failure
line by the operator after final commissioning of the
to do so can introduce problems that may impact the OEE.
serialized carton takes place. These basic ‘standard’
For example, space constraints could result in a situation
design requirements should always be considered and
where print and inspect equipment must be positioned
cannot always be implemented in an existing packaging
in the cartoner itself, which could interfere with the
line. Figure 3 gives an example of a recommended typical
mechanical design and performance of the cartoner.
serialization process flow at item level.
The inspection station and the final commissioning of
the serial number for the printed sales unit should also

Figure 3: Recommended typical serialization process flow on item level

Image reproduced from www.systechone.com

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3.1.3 Manual operations and OEE
It is important to consider the impact of manual operations
when evaluating the OEE of a serializing line. For the
purpose of this paper two examples of manual operations
that the impact OEE of a line have been provided below.
 1: Product extracted from the line for purposes
such as in-process control need to be
decommissioned and marked with a dedicated
rejection status (as it is required by some
countries). This forces the operators to either
stop the line and perform manual operation (thus
reducing OEE) or to find a technical solution to
do this operation without line stops.
2: The manual handling of rejected products requires
operators’ training and solid procedures. A typical
example is a product rejected by the print and
check equipment but considered good after
human inspection. If this could be considered
acceptable in a non-serialized environment, it
becomes critical in a serialized one.
Table 3: Aggregation equipment changes and the potential impact on OEE
Aggregation equipment changes
• I mplementation of automated case packer (side loader)
and elimination of bundling step
• Implementation of pack by layer concept
©BioPhorum Operations Group Ltd | September 2021
3.1.4 Aggregation for optimal OEE and
system performance
Aggregation is the documented parent/child relationship
between uniquely identified items and the uniquely identified
outer container that they are contained within, to improve the
efficiency of serialization business processes involving data
exchange and/or regulatory requirements. It is not required
by all markets that do require T&T, but it is still important
to understand how it can decrease or increase the OEE of a
packaging line. The following sections of this paper give points
to consider for the implementation and impact of aggregation
on OEE at each step of the aggregation process.
Aggregation of sales units to shipper
Whenever possible, and if the business case makes sense,
the replacement of any manual aggregation process (e.g.
manual scanning) with aggregation per automated case
packer should be considered. There are several advantages
to, and positive impacts on, OEE of doing so. For example,
by implementing aggregation per automated case packer,
the bundling process step could be eliminated, as bundling
is usually in place when case packing is a manual operation.
Table 3 lists some aggregation equipment changes and the
potential impact on OEE. Figures 4 and 5 provide a typical
automated case-packing aggregation flow sales unit to
shipper case and a typical ‘semi’-automated aggregation
flow sales unit to shipper case as recommended by the
authors of this paper.
Potential impact on OEE
Increase of output and labor reduction
Increase of output and reduction of data integrity issues caused
by human errors during scanning
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Figure 4: Recommended typical automated case packing aggregation flow sales unit to shipper case

Image reproduced from www.systechone.com

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Figure 5: Recommended typical semi-automated aggregation flow sales unit to shipper case

Image reproduced from www.systechone.com

Aggregation of sales units to bundle (6-panel bundler) to a stretch-banding bundler (4-panel

bundler) bundling process to support a fully automated
In terms of automation and OEE, for applications
process. For applications requiring a bundle label, an
requiring a bundling aggregation and a bundle label,
inspection verifying the serialized code and variable
automated bundling equipment is the best option
data information on the label occurs simultaneously
for aggregation and the labeling process. Due to the
with the bundle group inspection to ensure maximum
implementation of serialization and aggregation, many
data integrity (see Figure 6).
companies decided to migrate from a full overwrapping

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Figure 6: Recommended typical automated bundling aggregation flow sales units to bundle

Image reproduced from www.systechone.com

Aggregation of shipper cases to pallet (manual option) In this scenario, the operator begins the process by
opening a new pallet on the pallet controller application
Automated palletizing of shipper cases and pallet
running on the mobile computer, usually using a hand-
aggregation are possible if automated equipment is
held scanner. When a pallet is opened on the mobile
available and fully connected with the serialization
computer, the operator scans the serialized code on the
system. This scenario is considered the best option in
case and places the cases on the pallet. The operator
regard to OEE as it renders the operator’s intervention
repeats this process until the pallet has reached capacity
minimal (only required when a partial pallet needs to
or until the last case has been added to the pallet (see
be closed) and reduces any opportunity for human
Figure 7). The pallet is automatically closed once the
error. When there is not a business case for automated
pallet has reached full capacity. Partial pallets can be
aggregation, then manual palletizing supports manual
manually closed on the mobile computer. For applications
pallet aggregation on the packaging line. In terms of OEE,
that require an online pallet label printed, the packaging
this option is not as good, but there are considerations
module downloads a unique serial number to the pallet
and a recommended typical process flow that can help
printer when the pallet is closed.
increase OEE for this scenario.

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Figure 7: Recommended typical aggregation of shipper cases to pallet (manual option)

Image reproduced from www.systechone.com

3.1.5 Considerations for system design for deviation management process may also require an
serialization and aggregation update to include the necessary steps to facilitate the
management of discrepancies related to serialization/
The GAMP® 5 ISPE standard provides pragmatic industry
aggregation and, by extension, the impact on the OEE.
guidance towards achieving compliant, computerized
Serialization-related discrepancies are most likely to be
execution systems that are fit for intended use. This
found during the reconciliation process. Reconciliation
standard describes a flexible, risk-based approach to
is a fundamental stage in the pharmaceutical finished
compliant GxP-regulated computerized systems, based on
goods packaging process that ensures all regulatory
scalable specifications and verification. GAMP® 5 provides
requirements for distribution and sale of a medicine
guidance to ensure that the serialization and T&T systems
are met. As part of good manufacturing practices
(L3/L2 systems) used for routine packaging activities are
(GMP), reconciliation ensures that the correct number
maintained in a validated state throughout the lifetime of
of finished goods materials have been used during
the system. It also requires that the system has controls
production. Serialization reconciliation ensures that
in place to ensure the integrity of the data managed
serial numbers are used correctly for finished products
by the system, enabling delivery of the correct market
with traceability in each phase of the pharmaceutical
UPI requirements from a technical perspective. Before
packaging process, beginning with the generation
applying GAMP® 5, it is essential to describe all roles and
of serial numbers, and ending with the supply of
responsibilities, and to ensure that these are aligned across
serialized, finished goods to the market. The deviation
functional departments and systems. This also serves as
management process in a pharmaceutical environment
a baseline for a role-based and focused training approach
is normally led by the quality department. Since the
described further on page 27.
introduction of serialization, additional resources
3.1.6 Considerations for deviation management from information technology, production, technical
for serialization and aggregation operation and engineering have also played an
important part during deviation investigations and
After considering requirements for implementation of
in resolution processes.
serialization and aggregation on packaging line(s), the

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3.1.7 Using serialization OEE data management
for continuous improvement
Pharmaceutical packaging operations can learn a great
deal about how to improve their overall OEE by collecting
and analyzing serialization data (e.g. output and downtime)
from a machine, packaging line or a whole packaging area
over a longer period of time.
When serialization data is contextualized with data
from Manufacturing Execution System (MES) and
Enterprise Resource Planning (ERP) system data sources,
it allows data analytics to explore and compare specific
events in production that give insight into how to increase
efficiency. For example, by comparing serialization
data between shifts, variation in performance between
different shift teams can be identified and any need for
additional training and knowledge sharing between the
teams can be recorded as an action. Serialization data
can also be used to analyze unplanned downtime during
production of a high-value product. If the equipment is
fully utilized in such a case, any OEE reduction has a direct
impact on the financial result of the site and therefore
needs to be addressed.
©BioPhorum Operations Group Ltd | September 2021
After contextualization of serialization data for the
continuous improvement of OEE, the next step is to
use artificial intelligence (AI) to run predictive analysis
of packaging lines. To use AI effectively, increasing the
number of data points and collecting data from the entire
process (not only from packaging) are recommended.
Additional data sources could be any environmental
data such as humidity in granulation (which could have
an impact on the output and quality of the compression
process step). Laboratory data from the Laboratory
Information Management System (LIMS) is another
valuable data source for use in AI data analytics. These
very large data sets, when combined, enable companies
to set up AI models to define a self-learning algorithm.
Examples of AI algorithm-enabled use cases include:
• Predicting maintenance
• Predicting best equipment parameters
to reduce setup time
• Maximizing process yield
• Predicting tolerance violation
(e.g. “I am going to have a problem in 1 hour …”).
Serialization – challenges and good practices in packaging
19
operations based on experience of track and trace systems
 Key takeaways
• There is a concern about the potential negative impact of installing serialization equipment on the
packaging line OEE. A recent survey reported as much as a 30% drop in OEE levels.
• I nstallation of serialization and/or aggregation equipment into a brand-new packaging line is considered the
better scenario over installation into an already operational packaging line, because requirements can be
considered in the machine design from the outset.
• I t is important to consider process equipment flow when implementing T&T; failure to do so can introduce
problems that may impact the OEE.
•  eplacement of any manual aggregation process (manual scanning) with aggregation per automated case
R
packer should be considered.
• I n terms of automation and OEE, for applications requiring a bundling aggregation and a bundle label,
automated bundling equipment is the best option for aggregation and labeling processes.
•  utomated palletizing of shipper cases and pallet aggregation is considered the best option with regard to
A
OEE as it renders the operator’s intervention minimal.
•  ince the introduction of serialization, additional resources from information technology, production,
S
technical operation and engineering have also played an important part during deviation investigations and
in resolution processes.
• The mandatory GAMP® 5 ISPE standard provides pragmatic industry guidance towards achieving compliant
computerized execution systems, but it is also essential to describe all roles and responsibilities, and to
ensure that these are aligned across functional departments before applying GAMP® 5.
• By collecting and analyzing serialization data (e.g. output and downtime) and contextualizing it with MES and
ERP data sources, industry packaging operations can learn much about how to improve their overall OEE.
• There is an opportunity for industry to use serialization data and AI predictive analysis for continuous
improvement of packaging lines.

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4.0
Serialization technology
limitations in the
pharmaceutical industry
4.1 Software and hardware components of T&T systems
UPIs used in T&T systems must be unique. They must adhere to an agreed standard, and they must be printed,
verified and stored in a repository at the time of packaging. To fulfill these requirements, every packaging line
must be equipped with an IT infrastructure to facilitate printing and verification of required data. Such
fundamental changes to the technical configuration of manufacturing lines and packaging processes require
potential investment in the range of $100,000 or more. Such systems may also generate significant
challenges in the end-to-end supply chain process.
There are a number of T&T systems, developed by multiple months before being fully completed. In this fluctuating
manufacturers and retrofitted to thousands of packaging environment, where new features and regulations
lines around the globe. Each of these systems is best are announced relatively often, it can happen that
described as proprietary technology. The theoretical the new version of software is released before the
number of different permutations of packaging line models previous one has been fully implemented. Therefore,
and T&T systems is almost infinite. At the same time, the peak performance of lines is hard to achieve due to
lack of global standardization of T&T requirements means reoccurring qualification activities.
that systems cannot be designed in a future-proof way.
One solution to this problem, often applied in the
New regulations are announced frequently, which drive
industry, is to schedule line upgrades during the planned
software and/or hardware changes on the lines. New
maintenance shutdowns. However, as not all lines are
features and requirements, combined with security or end-
shut down at the same time, scenarios for running
of-life upgrades to operating systems, require a much more
different versions of the T&T software at the same site
frequent schedule of line changes. This contrasts with the
must be available. System suppliers must ensure that
upgrade schedule for traditional lines, which more often
new versions of software and hardware are backwards
than not, once installed, are rarely, or never upgraded.
compatible. Big, disruptive changes to systems, even
System providers have a seemingly impossible task – though they may accelerate innovation, are in fact the
to develop and test new versions of software, ensure most difficult to implement.
that they are free of errors and work in each possible
An important consideration (compared to a solution)
configuration. As a result, new releases have unexpected
for the pharmaceutical company is to factor in the
bugs or broken features that require remediation
product configurability when selecting a provider solution.
prior to implementation on commercial lines. As a
A product which is flexible and configurable enough to
consequence, the end-user – the pharmaceutical
be adapted to changing requirements could increase the
industry – must perform extensive testing cycles before
return on investment (ROI) and may also reduce the time
attempting qualifications, which in some cases may take
to implement modifications.

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4.2 Implementation of 4.3 Variable market requirements
new technologies Regulatory expectations from many countries see varied
As T&T technology slowly matures, regulatory agencies requirements regarding the layout of the readable part
and system manufacturers are looking at different ways of the UPI on the box. Variations include the need for
of improving functionality. One example of recent change manufacturing date in addition to expiry date, a range
is the implementation of ‘crypto codes’ by the Russian of date formats or other country-specific information.
Federation in 2020. This additional layer of security Some markets require specific barcode formats instead
is intended to improve product safety. This seemingly of the more standard data matrix. Given that each new
simple, single change of adding additional characters to format requires separate validation and change control,
the readable data and the data matrix code has a knock-on this added complexity increases the risk of errors, affects
effect of triggering multiple essential technical changes to processing and introduces additional verification steps.
packaging lines. The impact of changes to printed packaging materials must
also be considered, as it generates not only additional
Extending the example, the additional data to be coded
costs, but also affects the sustainability of the packaging.
in the data matrix exceeded the existing capacity of the
The industry must ensure that every imprinted pack is
codes with only two possible solutions: increasing the size
properly encoded and can be read by the end customer7.
of the code or increasing the code’s density.
Grading systems are affected by variations in the same
Increasing the size is possible only if there is enough way as the printers are, therefore, any steps towards
space on the packaging box. Alternatively, increasing standardization of requirements will have a great benefit
the code density requires higher resolution of print to verification.
and verification systems, which will have a knock-on
impact on the hardware and could potentially affect
the readability of the codes at the point of dispense.
In addition, to accommodate the change, extensive
software modifications were required. The requirements
proposed by the Russian Federation precipitated
discussions between regulators and industry to find a
compromise position, without which, disruption to the
supply chain was possible.
It is reasonable to expect that similar changes may be
requested in the future as technology evolves. Blockchain
is being evaluated as a potential next step in serialization.
This could bring a need for more data transfer and
encoding, more computing power and tighter integration
with ancillary systems. Future requirements can very
quickly outgrow the capabilities of installed hardware,
driving further investments to keep systems current.
Continuing dialogue between regulatory agencies,
pharmaceutical industry and system suppliers is essential
to ensure readiness for the future, patient safety and to
keep costs to healthcare systems low.

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operations based on experience of track and trace systems
4.4 Standardization –
the way forward
Many of the topics discussed in this paper relate to the
need for standardization. With respect to regulatory
requirements, commonly accepted approaches decrease
the risk of failures, reduce the cost of implementation and
ultimately improve patient safety.
The GS1 standards are widely endorsed by the healthcare
industry8. Beyond alignment, this common, global
serialization standard facilitates implementation of new
technologies into the system and enables functionalities
beyond serialization and T&T9, for example:
• Bedside scanning of drugs
• Recall administration
• Inventory management
• Automated data sharing.
The COVID-19 pandemic showed the importance of global
availability of protective equipment and diagnostic tests,
as well as effective treatments. It brought into sharp focus
the vulnerability of the global supply chain with respect to
robustness and agility. Global endorsement of standard
codification of packaging enables quick approvals, limits
the need for country-specific redressing activities,
improves the sustainability of packaging and, ultimately,
allows for drugs to be available more quickly and more
cheaply to patients.
While industry is striving for standardization of regulatory
requirements, a reduction of complexity of its systems
should also be a priority. Different systems must be able
to exchange data in a safe and error-free way. A full
implementation of standards defined by GS1 and Open-
SCS to facilitate optimal system design and integration is
needed, as well as co-existence of multiple vendors within
one packaging site10.

Key takeaways
•  undamental changes to the technical configuration of manufacturing lines and packaging processes
F
require potential investment of around $100,000 or more.
•  he lack of global standardization of T&T requirements means that systems cannot be designed in a
T
future-proof way. Future requirements can very quickly outgrow the capabilities of installed hardware,
driving further investments to keep systems current. Continuing dialogue between regulatory
agencies, pharmaceutical industry and system suppliers is essential to ensure readiness for the future,
patient safety and to keep costs to healthcare systems low.
•  ith respect to regulatory requirements, commonly accepted approaches decrease the risk of failures,
W
reduce the cost of implementation and ultimately improve patient safety.
• I ndustry is striving for standardization of regulatory requirements; the GS1 standards are widely
endorsed by the healthcare industry.
• Reduction of systems complexity should be a priority. Different systems must be able to exchange
data in a safe and error-free way. A full implementation of standards defined by GS1 and Open-SCS to
facilitate optimal system design and integration is needed3, as well as co-existence of multiple vendors
within one packaging site10.

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operations based on experience of track and trace systems
5.0
Decommissioning of serial numbers
5.1 Regulations and requirements
Reconciliation is a fundamental process of the pharmaceutical finished goods packaging process that ensures
all the regulatory requirements for the distribution and sale of a medicine are met. Serialization reconciliation
ensures that the serial numbers are used correctly for finished products with traceability in each phase of the
pharmaceutical packaging process, beginning with the generation of serial numbers, and ending with the supply
of serialized, finished goods to the market. In short, encoded serial numbers, printed on folding boxes, need to
be accounted for.

5.2 100% reconciliation options
and challenges
According to a requirement of the EU regulation of the
Falsified Medicine Directive (FMD) Q&A document
(version 18 question 8.6): “serial numbers that are not
actually used as data elements in unique identifiers should
not be uploaded and stored in the repositories system as
they represent a security risk for the system.”
For many companies, interpretation of this Q&A has
led to an assumption that the number of serial numbers
which are not accounted for should be close to 0%.
In other words, 100% reconciliation. The reconciliation
requirement is essential in order for effective safety
features and counterfeit detection. However, the
statement in the EU FMD Q&A leaves room for
interpretation and discussions are ongoing as to
whether the translation of a goal of non-accounted
serial numbers close to 0% is accurate.
Decommissioning is the act of documenting the
disassociation of a unique identifier from a specific
instance of an object class, typically when the object no
longer exists or reaches the absolute end of its life cycle
(i.e. after destruction or consumption of a product) and
is an important part of the serialization reconciliation
process11. Usually, decommissioning of the serial numbers
printed on to a folding box takes place at the location of
sale or point of dispense. This can be at a public pharmacy,
a hospital or a wholesaler. However, during packaging
and application of this unique identifier on to the folding
box, damage or loss can occur as well. If, at that moment,
the serial number has already been applied to the folding
box with the status ‘active’, the serial number on this
folding box needs to be decommissioned. The majority
of current systems for manufacturing serialized (not
aggregated) product are not able to perform automated
100% decommissioning of all lost packages from one
batch. Therefore, 100% reconciliation on lines without
aggregation is a manual or semi-automated task; this
is time-consuming and can have lines not running for
hours. If an additional decommissioning or aggregation
is not performed, all numbers produced are reported
to regulatory repositories, i.e. the numbers released to
regulators/repositories are correct but only a percentage
of the numbers are in the market due to unaccounted
losses, for example QC samples.

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5.3 Aggregation vs manual
reconciliation as a solution
for decommissioning
Aggregation of serialized products can eliminate the
need for decommissioning of serial numbers by the
manufacturer. Under this paradigm, only serial numbers
that are packed on a final pallet are recognized by the
aggregation software and therefore only these numbers
are communicated to the regulatory agencies. All losses
or damages that occur during the packaging process are
accounted for automatically. The software system is
designed in a way that these ‘non-packed’ serial numbers
are set to an ‘inactive’ status automatically. The risk to
the patient of receiving a counterfeit product is also
significantly reduced. Therefore, implementation of an
aggregation approach can be a good option, even if it is
not (yet) required by the receiving country. However,
100% aggregation requires an upgrade of the packaging
lines and is often weighed against the fact that only some
countries require it.
When not using an automated aggregation process, a
manual process can be established in order to perform
the reconciliation of serial numbers continuously for
serialized batches. This method also has its limitations
when considering larger batch sizes, where losses can be
high, and decommissioning becomes time-consuming.
Software systems – in-line or off-line – can be established
to account for losses during the manufacturing process.
Off-line systems can be especially helpful when managing
deviations, allowing the current line to be used efficiently
for the production of another batch.
The implementation of serialized products has focused
attention on losses due to the increased number of serial
numbers that are sent to the repositories. Regardless of
whether a company performs 100% manual reconciliation
or uses aggregation, and in terms of the OEE, the
percentage of loss should be continuously reduced, good
line design is the best option and key to avoiding damage
or loss and the need for decommissioning in the first place.

Key takeaways
•  he statement in the EU regulation of the FMD Q&A document (Version 181 question 8.6) leaves room
T
for interpretation and discussions are ongoing as to whether the translation of a goal of non-accounted
serial numbers close to 0% is accurate. Many companies interpret this as 100% reconciliation.
• Aggregation of serialized products can eliminate the need for decommissioning of serial numbers by
the manufacturer, but 100% aggregation requires costly line upgrades and is often weighed against the
fact that only some countries require aggregation.
•  egardless of whether a company performs 100% manual reconciliation or uses aggregation, and in
R
terms of the OEE, the percentage of loss should be continuously reduced, good line design is the best
option and key to avoid damage or loss and the need for decommissioning in the first place.

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6.0
Training for serialization
6.1 The need for specialized training on serialization
After it is created, each SN is assigned to a certain product or SKU and can be used only for this product. This SN
is then transferred between all servers/systems included in the process of serialization. These servers/systems
are called L1-L5 (Level 1 through Level 5, see Figure 8). As such, serialization is an integral part of production and
release specification. In markets where it is required, serialization is considered a critical quality attribute as it is
not possible to release a product unless correct serialization is verified. As with any GMP procedure, serialization
training is mandatory.

Figure 8: L1–L5 serialization system levels

Level 5:  Global-level software and system that enable management of all serialization
and regulatory data with partners, customers and regulatory authorities

Level 4: Company-level software and systems that enable management of

all serialization and regulatory data and business processes

Level 3: Site-level software and systems that verify the integrity of

information submitted to the enterprise system

Level 2: Production line software and systems that manage devices that serialize and pack
product and support device integration with site systems for conducting warehouse operations

Level 1: Device software and systems, e.g. cameras, printers, vision

inspection, rejection and materials-handling on the line

Training is an area of serialization with which the industry
is struggling. There are aspects of serialization that are
highly technical and elements of the process that are both
virtual and practical. In addition, variability in intentional
regulation has led to various technical requirements from
health authorities in different markets. This, in combination
with a lack of industry standards, has led to the need
for different requirements for serialization training for
functions at different sites. For example, training for one
market’s serialization requirements does not apply to every
market and it is therefore necessary to develop specialized
training for many of the supplied markets. Any training
for serialization needs to reflect these aspects and, just
as aseptic processes have specialized training, the same
should apply for serialization.
The best-case scenario would be that specific
requirements for markets should be standardized so that
an operator on the line does not need to be trained on
market specificities. Given that this is not the current state,
the following sections have been written with existing
variabilities and all system levels in mind (operators,
regulatory, etc.)

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operations based on experience of track and trace systems
6.2 Training with L1–L5 systems updates. Identifying correct serialization training for
each role is challenging, since a multidisciplinary team of
Implementing and maintaining a serialization training
subject matter experts (SMEs) needs to work together
plan is essential to organizing effective use of serialization
to allocate the right trainings to each role. Also, the
in a pharmaceutical company. A training plan has
bigger the company or site, the more complicated the
to be available for each company role/position that
training plan can be. Figure 9 gives an example of how
interacts with the L1–L5 systems. Existing curricula
local roles and responsibilities correspond to the L1–L5
need to be updated with additional training required for
system and the corresponding training required. Mapping
serialization/aggregation. Since serialization/aggregation
training to the L1–L5 levels helps ensure implementation
processes are still new and changing, training plans often
of serialization/aggregation training to all required
have to be created from scratch and will need frequent
employee roles/positions.

Figure 9: Example from a major pharmaceutical company’s internal SOP describing how local and global roles and responsibilities correspond to the L1–L5 system
and required training

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operations based on experience of track and trace systems
Given that serialization and aggregation are relatively new
processes, there are two additional points to consider.
First, there is generally no long-term experience with the
processes in the pharmaceutical industry so developing
experts in serialization/aggregation processes should be
part of the overall training goal.
Second, once established, the L1–L5 serialization system
needs to be developed, modified and updated to reflect
changes in market variability. For this reason, periodic or
corrective retraining is highly recommended and systems
need to be established that will successfully identify when
the retraining needs to be performed. If an employee
fails to perform a job role effectively, then corrective
retraining is necessary to put them back on the right track.
Periodic retraining is sometimes required for specific
operational steps that are performed less frequently to
ensure employees can always perform tasks according to
standard operating procedure (SOPs).
Classroom training is most appropriate for a wider
audience, including employees working on different
functions and positions. It is effective for presenting the
general concepts of serialization, the flow of process
steps and is applicable for all serialization levels (L1–L5).
However, for L1, L2 and L3 system levels, additional
considerations and accommodations need to be made to
the virtual and practical nature of the tasks.
6.3 L3 system – site-level support
L3 system activities include the creation and maintenance
of a proper database for each type of product. It is
essential that product master data are correctly
configured, e.g. finished product code, product name and
product GTIN. This prevents product mix-up at server
level, based on assigned designation. Once the database is
correctly configured, serial numbers can be transferred.
In order to train people for these critical activities, it is
recommended to establish a dedicated L3 training team.
Training should be completed in a classroom with access
to a training environment for an L3 system. If all training
participants have access to the system (e.g. on a laptop)
this could be a form of on-the-job training (OJT). For
this type of training, a ‘sand-box’ L3 system is necessary
to ensure the training does not impact the commercial
database or commercial production. If classroom training
is hard to organize, virtual (online) training is a good
alternative. As a general rule, smaller groups are more
effective for both classroom and online training.
©BioPhorum Operations Group Ltd | September 2021
6.4 L1/L2 system – Training activities
on the line
L1/L2 activities on the line include start of serialized batch,
unit pack serialization process and exceptions handling on
L2 and L1 systems. If aggregation is required, additional
process steps including serializing higher packaging levels
(e.g. bundles, shipper cases and pallets) and aggregating
serialized products are implemented.
For these types of activities, the best approach to training
is individual OJT on the packaging line, where possible, on
a dedicated training facility/line. This type of training is
mandatory in the secondary packaging operator training
curriculum. This training should include serialized batch
start, printer/labeler/camera system setup, product
serialization, exception handling and end-of-batch
procedure. Exception handling includes manual changing of
serial number status, decommissioning damaged products
and sampling serialized products on the line. If the operator
works on a packaging line with aggregation, additional
steps should be included in the training, such as aggregating
unit of sale to a shipper case, and exceptions handling such
as de-aggregating unit of sale from the shipper case, and
reworking. During batch start procedure, the importance of
connecting to the correct product database and preventing
mix-up, should be explained. During the end-of-batch
procedures, for cross check and comparison of quantities for
active serial numbers and quantities of finished products,
packed on pallets must be demonstrated.
6.5 Exam and certification
After training is completed, an internal training exam
is recommended to certify that the employee has been
trained. Having a certifiable exam can help showcase
transferable industry knowledge and will motivate trainees
to be fully engaged with training. The results of the exam
will also provide immediate feedback on the efficacy of
the curriculum/training plan so these might be adjusted to
address where trainees are underperforming. The exam
could be in the form of a practical exam, where the trainee
performs selected activities on the line alone, e.g. starting
a batch, decommissioning a product manually or serializing
several products. Exams in the form of real-production
scenarios can be very beneficial to assess if the trainee
is capable of performing tasks efficiently or if additional
training is needed.
Serialization – challenges and good practices in packaging
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operations based on experience of track and trace systems
6.6 Dedicated training facilities/lines
This type of OJT is time- and resource-consuming and
cannot be performed on a commercial batch. It can cause
unwanted production downtime and has to be planned
well ahead according to scheduled daily/weekly/monthly
production plans. For these reasons, a dedicated training
facility or line is recommended so that training can be
performed in a dedicated environment without impacting
commercial production. The added benefit is that the
training facility is constantly available for practical
training. A training facility can have various production
configurations that do not have to be validated and can
be modified or inactivated according to training type.
This variability enables training to be focused on one
aspect of the process while disabling other process steps
and functions, which cannot be carried out on commercial
equipment/recipes without validation.
Other than for training purposes, dedicated training lines
could be used for L2/L3 system testing and validation.
This can be achieved by assessing a level of equivalence
between the test line and the production line on a
functional level. A common example of a dedicated
training line is a print and check machine in conjunction
with a case packer/palletizer: this line would allow
to recreate the most common serialization scenarios
present on a line. Such line would also be useful during
investigation of root causes to verify assumption and
recreate problematic scenarios.
It is recognized that building a dedicated training facility
is a costly and time-consuming process. Maintaining a
dedicated training facility/line also has its challenges:
it should cover all commercial line components and
functionalities; keeping the training facility line up to date
with commercial lines is time-consuming and software
updates, new configurations and functionalities have to be
constantly added to keep up with the commercial lines.
For this kind of training, a dedicated training team needs
to be established and maintained. This team can specialize
in serialization/aggregation training topics, and focus on
developing, writing and improving training materials and
procedures. The team should include both experienced
trainers and serialization/aggregation SMEs. This team
should be constantly informed about real commercial
production challenges, deviations and investigations.
Real production will give this training team feedback
on any training materials that could be improved, e.g.
with more detailed process step descriptions or adding
additional workarounds for new challenges that were
initially overlooked. Setting up a dedicated team has
to be carefully organized and planned well in advance.
Forming a team can be a challenge since serialization is
a relatively new process, and serialization/aggregation
SMEs are scarce. Additionally, general SMEs, despite
having wide knowledge about end-to-end serialization
processes do not have specific knowledge required on
the line. Therefore the only logical choice is to include
SMEs who are experts in specific activities performed on
the line. Since serialization processes on the line include
a wide range of different activities, the training team
should be multidisciplinary to cover the range of topics
required related to IT, quality, engineering, automation
and production.

Key takeaways
•  training plan has to be available for each company role/position that interacts with the L1–L5 systems
A
and existing curricula should be updated with additional training required for serialization/aggregation.
•  eveloping experts in serialization/aggregation processes should be part of the overall training goal, to
D
adjust for lack of experience of training for serialization in the industry.
•  ue to market variability and frequent system updates, periodic or corrective retraining is highly
D
recommended and systems need to be established that will successfully identify when retraining needs
to be performed.
•  ince serialization processes on the line include a range of different activities, the training team should
S
be multidisciplinary to cover the range of topics required related to IT, quality, engineering, automation
and production.
• Certifiable exams can help showcase transferable industry knowledge and will motivate trainees.
•  dedicated training facility or line for L1–L3 level training is recommended to avoid unwanted
A
production downtime.

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References
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https://cdn.who.int/media/docs/default-source/substandard-and-falsified/policy-papers/policy-paper-traceability-
en.pdf?sfvrsn=cee6e351_12&download=true
2  orld Health Organization, Substandard and falsified medical products (January 31, 2018)
W
https://www.who.int/news-room/fact-sheets/detail/substandard-and-falsified-medical-products
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Best Practices, webinar February 4 2021
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7 European Commission Directorate-General for Health and Food Safety Safety features for medicinal products for human
use, Questions and Answers May 2021 https://ec.europa.eu/health/sites/health/files/files/falsified_medicines/qa_
safetyfeature_en.pdf
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industry 2015 https://www.gs1.org/sites/default/files/docs/healthcare/endorsement_paper-hd.pdf
9 McKinsey & Company Strength in unity: The promise of global standards in healthcare
http://www.gs1.org/healthcare/mckinsey
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https://cdn.who.int/media/docs/default-source/substandard-and-falsified/policy-papers/policy-paper-traceability-
11 
en.pdf?sfvrsn=cee6e351_12&download=true World Health Organization Policy paper on transferability of medical products
October 2020

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Permission to use
The contents of this report may be used unaltered as
long as the copyright is acknowledged appropriately
with correct source citation, as follows ‘Entity,
Author(s), Editor, Title, Location: Year’

https://doi.org/10.46220/2021FF002

Disclaimer
This document represents a consensus view, and as
such it does not represent fully the internal policies of
the contributing companies.

Neither BioPhorum nor any of the contributing

companies accept any liability to any person arising
from their use of this document.

The views and opinions contained herein are that of

the individual authors and should not be attributed to
the authors’ employers.

Serialization – challenges and good practices in packaging

©BioPhorum Operations Group Ltd | September 2021 31
operations based on experience of track and trace systems