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Procedia Manufacturing 51 (2020) 1673–1679

30th International Conference on Flexible Automation and Intelligent Manufacturing (FAIM2021)

30th International Conference on Flexible Automation and Intelligent Manufacturing (FAIM2021)
15-18 June 2021, Athens, Greece.
15-18 June 2021, Athens, Greece.
Operational
Operational Risk
Risk Management
Management in the Pharmaceutical
in the Pharmaceutical Supply
Supply Chain
Chain Using
Using
Ontologies and Fuzzy QFD
Ontologies and Fuzzy QFD
Juan Carlos Osorio Gómezaa*, Katherine Torres España aa
Juan Carlos Osorio Gómez *, Katherine Torres España
a
Universidad del Valle, Street 13 No 100-00, Cali, 760001, Colombia
a
Universidad
* Corresponding author. Tel.: +57 2 3212167-3572. del Valle,juan.osorio@correounivalle.edu.co
E-mail address: Street 13 No 100-00, Cali, 760001, Colombia
* Corresponding author. Tel.: +57 2 3212167-3572. E-mail address: juan.osorio@correounivalle.edu.co

Abstract
Abstract
Operational Risk Management is an important aspect of current Supply Chain Management activities. Supply Chain Risk
Operational
ManagementRisk Management
Systems involve atisleast
an risk
important aspect ofrisk
identification, current Supply Chain
prioritization, Management
and risk management. activities.
Risks inSupply Chain Risk
the pharmaceutical
Management Systems involve at least risk identification, risk prioritization, and risk management. Risks in the
supply chain can affect not only the company’s performance but also can affect human life. That is an important reason to manage pharmaceutical
supply
risks in chain can affect
the chain. Therenot
are only
manythe company’s
approaches toperformance
supply chain but
riskalso human
can affectthat
management life. on
focuses That is an important
operational reasonapproaches
risks. These to manage
risks in the chain. There are many approaches to supply chain risk management that focuses on operational risks. These
look to mitigate or eliminate the most critical risks in order to achieve the results that the chain expects. This paper presents a approaches
look to mitigate approach
methodological or eliminate theOntologies
using most criticalandrisks in order
Fuzzy Qualityto Function
achieve the results that(FQFD)
Deployment the chain expects. This
to eliminate paper presents
or mitigate the mosta
methodological approach using Ontologies and Fuzzy Quality Function Deployment (FQFD) to eliminate
important risks. Our proposal was applied to a pharmaceutical company in Colombia, particularly in the transport and storage or mitigate the most
of
important risks. Our
finished products for proposal was this
export. With applied to a pharmaceutical
approach company
the company defined in Colombia,
actions particularly
oriented to in the transport
the most critical risks. and storage of
finished products for export. With this approach the company defined actions oriented to the most critical risks.
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by Elsevier
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open accessPublished by Elsevier
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the CC BY-NC-ND license https://creativecommons.org/licenses/by-nc-nd/4.0/)
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This is an open access
access article under
article under the CC
the scientific BY-NC-ND
CC BY-NC-ND licenselicense (https://creativecommons.org/licenses/by-nc-nd/4.0/)
https://creativecommons.org/licenses/by-nc-nd/4.0/)
Peer-review under responsibility of the committee of the
Peer-review underresponsibility
Peer-review under responsibility ofof
thethe scientific
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Keywords: Operational risk, ontologies, fuzzy Quality Function Deployment, pharmaceutical supply chain
Keywords: Operational risk, ontologies, fuzzy Quality Function Deployment, pharmaceutical supply chain

1. Introduction and risk monitoring (See Fig. 1). In this paper the first three
1. Introduction and risk
stages aremonitoring
considered.(See Fig. 1). In this paper the first three
Supply chain risk management is one of the most important stages are considered.
Supply
aspects chain
in the risk management
current supply chain,isand oneaccording
of the most important
to [1,2] there
aspects
are two classes of risks in the supply chain, operational risk,there
in the current supply chain, and according to [1,2] and
are two classes
disruptive risks.ofAlthough
risks in the supply chain,
operational riskoperational
has a lowerrisk, and
impact
disruptive risks.disruptive
Althoughrisk,operational risknot
hasconsidering,
a lower impact Fig. 1. Supply Chain Risk Management System [3]
compared with if they are that Fig. 1. Supply Chain Risk Management System [3]
compared
could significantly affect the company's performance. It is that
with disruptive risk, if they are not considering, the
could The pharmaceutical industry can be defined as a complex of
reasonsignificantly affect theforcompany's
because is important companiesperformance. It is the
and supply chains to The pharmaceutical
processes, operations, industry can be definedinvolved
and organizations as a complex of
in the
reason because is important for companies andOperational
supply chains to processes, operations,
take action
take action
towards the operational risks. risk discovery, development,andandorganizations
manufactureinvolved
of drugsin andthe
includes riskstowards
associated thewith
operational risks. Operational
people, processes, machines, risk and discovery, development,
medications [4]. and manufacture of drugs and
includes
external events and always is not possible to eliminate, soand
risks associated with people, processes, machines, in medications [4].
external events and always is notaction
possible to eliminate, Global pharmaceutical supply-chain risk mitigation has
these cases companies must take to mitigate them. so in Global
become pharmaceutical
an important issue insupply-chain
the corporate risk mitigation
boardroom has
[5]. The
these
Ancases companies
operational must take action
risk management to mitigate
system includesthem.
at least the become an important issue in the corporate boardroom [5]. The
pharmaceutical industry, in particular, is characterized by
identification, prioritization, and managementat least
An operational risk management system includes the
phases. pharmaceutical
highly technical industry, in particular,
core functions is development
that include characterized andby
identification, prioritization, and management
According to [3] supply chain risk management includes four phases. highly technical core functions that include development and
According manufacturing and this industry has specificities that
stages: risk to [3] supply chain
identification, risk management
risk prioritization, includes four
risk management, manufacturing
distinguish it fromand this
other industry
domains hasproduct
such as specificities that
perishability,
stages: risk identification, risk prioritization, risk management, distinguish it from other domains such as product perishability,
the crucial importance of safety and security, legislation and
the crucial importance of safety and security, legislation and
2351-9789 ©©2020
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theElsevier
CC BY-NC-ND Ltd.
CC BY-NC-ND license (https://creativecommons.org/licenses/by-nc-nd/4.0/)
license https://creativecommons.org/licenses/by-nc-nd/4.0/)
This is an open
Peer-review
Peer-review access
under
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of the CC BY-NC-ND
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2020.
Peer-review under responsibility of the scientific committee of the FAIM 2020.
10.1016/j.promfg.2020.10.233
1674 Juan Carlos Osorio Gómez et al. / Procedia Manufacturing 51 (2020) 1673–1679
2 Osorio J.C- Torres K/ Procedia Manufacturing 00 (2019) 000–000
jurisdictional quality guidelines, and special conditions for
storing and distributing different types of products [6].
Complex global supply chain networks increase the
possibility of a negative impact of potential supply chain
disruptions on firm performance [7].
The pharmaceutical industry is also facing tremendous
uncertainty and fluctuations in demand, which may challenge
its business sustainability in both local and international
markets [8].
Although the pharmaceutical firms cannot entirely eliminate
the risk portfolio they face in their daily operations, they can
enable an environment conducive for responsive risk mitigation
[9].
The supply chain of pharmaceutical products is
characterized by high complexity, and supply and delivery
channels to customers are limited and highly regulated. The
complexity is considered as one of the main barriers to
performance and efficiency improvements of a pharmaceutical
supply chain [9].
There is no room for error as it might directly affect health
of population and nations. This is the reason why the costs of
stock outs for pharmaceutical products cannot be expressed
only in monetary terms [10].
Pharmaceutical industry is known as one of the strongest in
R&D industries that paid comparatively less attention to
development of supply chain technology. A considerable
increase in the number of generic production companies,
require that the pharmaceutical industry to turn its attention to
challenges in supply future demand forecasting and inventory
management, thus confirming the importance of the
effectiveness of a supply chain for the industry [10].
Performance of pharmaceutical companies as a main player
in pharmaceutical supply chain has significant effect on supply
chain management efficiency. Risk identification and
mitigating them in pharmaceutical companies not only can lead
to process optimization, productivity increase and minimizing
business risk, but also will help health systems to meet goals of
supply chain management; Accessibility, Quality and
Affordability [11]. Fig. 2 show a typical pharmaceutical supply
chain [10].
Product Flow
Product Flow
Fig. 2 Pharmaceutical supply chain [10]
2. Literature review
2.1. Risk management in pharmaceutical supply chain
The pharmaceutical industry takes the second lead among
the most profitable industries in the world. A small disruption
in pharmaceutical supply chains can have a detrimental effect
on the health of individuals [12].
The pharmaceutical industry can be defined as a complex of
processes, operations and organizations involved in the
discovery, development and manufacture of drugs and
medications [4]. The pharmaceutical industry in particular is
challenged by constant advancements of its development and
production functions [13]. A more sustainable pharmaceutical
supply chain should be implemented to match future operations
and management of the pharmaceutical products across the
entire life cycle [14]. For this, risk management is an important
activity in the modern pharmaceutical supply chains.
Supply of medicine as a strategic product in any health
system is a top priority. Pharmaceutical companies, a major
player of the drug supply chain, are subject to many risks.
These risks disrupt the supply of medicine in many ways such
as their quantity and quality and their delivery to the right place
and customers and at the right time. Therefore, risk
identification in the supply process of pharmaceutical
companies and mitigate them is highly recommended [4].
Various risks arise with outsourcing logistics in the case of
pharmaceutical supply chains. To maintain a competitive
advantage, organizations must manage risks proactively. To do
that, risks need to be identified and assessed [13].
While pharmaceutical supply-chain risks are often related to
a lack of information visibility or deviations in the information
and physical drug flows from upstream to downstream,
increased knowledge of essential risk management procedures
and structures can significantly improve the ability of decision
makers in implementing appropriate mitigation treatments for
identifiable risk portfolios [5].
According to [7] organizations have to focus on developing
risk management practices to mitigate the disruptive impact of
risk drivers.
Some recent works that consider risks in pharmaceutical
supply chains can be mentioned such as [15], in this paper they
considering the multidimensional nature of pharmaceutical
supply-chain risk, used a fuzzy TOPSIS methodology to
prioritize risks.
[12] presented an integrated hybrid approach that can be
applied for supplier selection and designing a resilient supply
chain. The approach is based on data envelopment analysis
(DEA) and mathematical programming model. They proposed
a fuzzy DEA model to evaluate the efficiency of each potential
supplier. Then, based on the obtained efficiency, a two-stage
possibilistic-stochastic programming model was formulated
for supplier selection and determining resilience strategies
under disruption and operational risks.
[16] developed a study to investigate the risks in the
Pharmaceutical Supply Chain in Ghana. Their main
conclusions were the principal risks associated with the
 Juan Carlos Osorio Gómez et al. / Procedia Manufacturing 51 (2020) 1673–1679
Osorio J.C- Torres K / Procedia Manufacturing 00 (2019) 000–000
pharmaceutical supply chain include difficulty in obtaining raw
materials, the unethical attitude of pharmacists and chemical
sellers, low income of consumers, poor inventory management
and reverse logistics not being encouraged in the
pharmaceutical industry in Ghana.
In [17] they analyze optimal risk mitigation strategies for a
single firm that is exposed to supply chain disruption risk. They
analyzed the three risk mitigation strategies for the
pharmaceutical company using an optimization model.
[5] presenting a decision model that takes into consideration
the risks of outsourcing logistics in the pharmaceutical supply
chain. To risk identification and assessment they used a multi-
criteria model using ELECTRE III.
In [8], they proposed a decision model, based on the
Analytical Hierarchy Process (AHP) method to identify and
analyze the risks occurring in the supply chains of the
pharmaceutical industry and, for evaluating risks in
pharmaceutical supply chains.
In recent work, [18] using a systems dynamics model to
study the effect of production stops because of quality
breakdowns on operational and financial performance. They
consider different forms of customer adaptation to varying
service levels ranging from no response at all to a very strong
reaction that is only extremely slowly reverted. They used the
simulation experiments to analyze the behavior of operational
and financial performance indicators over the stable phase of
the market cycle of a patented drug when breakdown
characteristics, product characteristics, and inventory levels are
varied.
Considering the importance of the pharmaceutical sector
and the current literature about the operational risk
management, this paper presents a methodological approach to
operational risk management in pharmaceutical companies that
involve a novel approach using ontologies to risk identification
and FQFD to risk prioritization.
2.2. Ontologies
An ontology defines a common vocabulary for researchers
who need to share information in a domain [19]. They include
not only the conditions that are defined explicitly, but it also
includes the knowledge that can be inferred [20].
An ontology defines the terms used to describe and represent
an area of knowledge. They encode knowledge in a domain and
also the knowledge that extends the domains, in this sense, they
make the reusable knowledge [20]. Ontologies have been used
in different fields. In risk management, we can mention some
recent applications such as [21 - 28].
In the specific case of the pharmaceutical supply chain we
can mention [22], they developed an ontology using the
OWLGRed tool from a UML model to risk management in the
medicines supply chain in Morocco, principally in the public
hospitals which handle the purchase, storage, and distribution
of pharmaceuticals in these institutions.
In [28] an ontology for risk identification is proposed, this
was used in the ground transportation activities. See Fig. 3
1675
3
Fig. 3 Ontology to operational risk identification [28]
2.3. Fuzzy Quality Function Deployment - FQFD
Quality Function Deployments (QFD) is a well-known tool
used principally in product design and development, but it has
transcended these applications and it has been included as a
multi-attribute decision-making tool.
Fuzzy Logic incorporates the ambiguity inherent to reality
and present in the linguistic judgments of the experts in the
organization. It is defined as a tool that helps to express
mathematically the intermediate values present in real
situations, which are far from a simple yes or no, a true or false.
There are intermediate values when using qualitative variables
related to expert judgment or preferences from people. Fuzzy
Logic becomes important to make these models closer to the
realities in organizations [29].
Joining QFD and Fuzzy Logic enables us to involve
ambiguity present in judgments and subjective evaluations of
those involved in the process, to improve the results of its
application. In recent years, the fuzzy quality function
deployment (FQFD) has become a widely used quality tool
developed to satisfy customer need in product design and
development [29].
Some of the most recent papers that use QFD or FQFD in
risk management are [29–37].
3. Methodological approach
We propose a methodological approach using ontologies to
risk identification, fuzzy QFD to risk prioritization, and cause-
effect diagram to define actions oriented to risks mitigation or
elimination. Fig 4 presents the most important activities in each
phase.
The ontology classes were defined according to [28] and
they are: risks, occurrence probability, sources, processes,
impact and managerial strategies, and processes have
subclasses transportation and warehousing. That idea is sharing
information related to risks across the whole supply chain.
First and using the ontology developed the operational risks
are defined. For this, the queries shown in table 1 are used; it
takes into account the occurrence probability and the impact
magnitude. Both values (in linguistic variables) are included in
the ontology for each one of the risks.
1676 Juan Carlos Osorio Gómez et al. / Procedia Manufacturing 51 (2020) 1673–1679
4 Osorio J.C- Torres K/ Procedia Manufacturing 00 (2019) 000–000

4. Results

The methodology was applied in a pharmaceutical

laboratory dedicated to the development, manufacture and
marketing of pharmaceutical products and functional foods for
human consumption since nationally and internationally.
The organization has more than 100 years in the market,
and currently, the company has a production plant dedicated to
the manufacture of various pharmaceutical forms in the city of
Santiago de Cali, Colombia.

4.1. Risk Identification

For the identification of risks, ontology developed by [28]

was used. In this particular case, the main risks related to
transport and storage were included. To include these risks, the
bibliographic review was carried out and additionally included
Fig. 4 Methodological approach those that had previously appeared in historical records (see
table 2), in addition, for each of the risks the probability of
Table 1. Queries to risk identification
occurrence and the impact, according to the structure of the
Probability Impact ontology developed and using the linguistic scale shown in
Very Low Very Hight Table 3.
Low High
Table 2. Main Risks in transport and storage in pharmaceutical companies
Low Very High
Risk number Risk name
Medium High
R1 Storage temperature conditions outside
Medium Very High acceptable limits
High High R2 Improper handling of finished product
High Very High pallets
Very High Medium R3 Poor packaging
Very High High R4 Poor pest control in storage warehouses and
transport vehicles
Very High Very High
R5 Cross-contamination of finished product
R6 Product contamination
Once the risks are identified, the next step is prioritizing
them. For risks prioritization the FQFD approach its proposed. R7 Primary packaging material failures
In figure 3 the FQFD has presented according to [29] The result R8 Bad road conditions
is risk ranking that considers the impact of all risks in the R9 Product defects
company strategical objectives, particularly some of them R10 Vehicles breakdowns
related directly with processes in the study. R11 Disruption in the cold chain
Previous to phase 1, it is necessary to define the team
R12 Crime, theft and terrorist acts
(experts of the company that are directly involved in the
decision process) and the processes for which risk prioritization R13 Improper fleet
will be conducted. Another fundamental issue that is required R14 Invasive inspections by regulators
before phase 1 is that risks have been identified and thoroughly R15 Pressure changes during transport that cause
covered according to the knowledge of experts, company damage to the products
historical information, from the supply chain and secondary
information sources [29]. Table 3. Linguistic scale and equivalent triangular fuzzy numbers [38]
To define the mitigation or elimination actions the Ishikawa Linguistic variable Triangular fuzzy number
chart is proposed. And once the most important risks are Very Low (VL) (0,1,2)
avoided or mitigated, the company must continue with the
Low (L) (2,3,4)
other risks in a continuous improvement cycle.
The defined actions must be included in the ontology in the Medium (M) (4,5,6)
managerial strategies class in order to serve as relevant High (H) (6,7,8)
information for future processes in the operational risk Very High (VH) (8,9,10)
management process by the company or any other echelon in
the chain. To define which of the identified risks would go to the
prioritization phase, queries were generated in the ontology
 Juan Carlos Osorio Gómez et al. / Procedia Manufacturing 51 (2020) 1673–1679 1677
Osorio J.C- Torres K / Procedia Manufacturing 00 (2019) 000–000 5

according to the following possible combinations of the R7 Primary packaging material 286 High
probability of occurrence and impact (see Table 1). failures
In applying the queries in the ontology, the results presented R4 Poor pest control in storage 241 Medium
in Table 4 were obtained. It is important to notice that not all warehouses and transport vehicles
of the queries had results because not all combinations exist in R3 Poor packaging 225 Medium
the risks present in this process. With these risks, prioritization R9 Product defects Product defects 225 Medium
is carried out, in accordance with the proposal for the R2 Improper handling of finished 223 Medium
implementation of the FQFD presented in [29]. product pallets
R11 Disruption in the cold chain 223 Medium
Table 4. Identified Risks
R14 Invasive inspections by regulators 212 Medium
Query Probability of Impact Risk Number
occurrence R5 Cross-contamination of finished 206 Medium
product
Q3 Medium High R4, R5, R6, R9
R6 Product contamination 201 Low
Q6 High High R2, R3, R7, R13,
R14
Q7 High Very High R11
Table 8. Reference values to risk prioritization
Criticality Level Reference value
4.2. Risk Prioritization
Very Low 46
According to the FQFD methodology, What's and their Low 126
weights are shown in Table 5, and How's and their respective Medium 206
weights in Table 6. High 286

Table 5. What´s and Weights of them Very High 366

What´s Weight
Physical security in the process (7,8,9)
4.3. Risk Management
Product in good condition (6,7,8)
To define actions oriented to risk mitigation or elimination,
Optimal cold chain (7,8,9) the cause analysis was developed. Table 9 shows the main
Good hygiene practices in the transporter vehicle (5,6,7) causes according to the cause analysis categories, related to the
Full load delivery (4,5,6) first critical risk “improper fleet”.

Table 9. Causes analysis for Risk “improper fleet”

Category Possible cause Observations
Table 6. How´s and Weights of them Machine Vehicles in bad There is no checklist for the
How´s Weight conditions verification of each vehicle,
which validates that they meet all
Product delivery on time (27,38,52)
the requirements agreed between
Delivery of the requested quantities (30,42,56) the company and the transporter
Complaints associated with product breakdown (34,47,61) Environment Cleaning Temperature control is a vital
Logistics cost of transportation (29,40,54) conditions and factor in the transport of
temperature are pharmaceutical products,
Rejection of bad product (20,31,43) not met during however this parameter is not
transport being checked properly, because
there is no vehicle inspection
Finally, Table 7 shows the prioritization in which, it is clear guide.
that the risks R13 (Improper fleet) and R7 (Primary packaging
Methods No verification There is no checklist, which
material failures) are the most critical and therefore, those that of vehicle allows the person in charge of the
must be addressed as a priority by the company. Table 8 shows conditions inspection of the vehicles, to
the baselines that were considered in accordance with the check the optimal condition of the
FQFD to establish the level of criticality of the risks examined. same, before the entry of the
It is important to clarify that these values change from cargo and after it.
application to application because these values are calculated Methods There is no The currently used transport
according to the weights of what's and how's are used for risk certification providers are not covered under
program for the supplier certification program,
prioritization. transport i.e. the contract between the two
providers parties is not covered under a
Table 7. Main Risks in transport and storage in pharmaceutical companies
quality agreement and the
Risk Risk name Final Risk Classification supplier is not regularly audited
number priority for verifying their compliance.
Index
R13 Improper fleet 288 High
1678 Juan Carlos Osorio Gómez et al. / Procedia Manufacturing 51 (2020) 1673–1679
6 Osorio J.C- Torres K/ Procedia Manufacturing 00 (2019) 000–000

According to the causes previously identified, two actions
aimed at risk mitigation are proposed, which would solve the
four confirmed causes:
• To establish quality assurance programs that provide for
procedures to certify that all operations have been carried
out by the requirements, standards, and procedures
applicable. Also, it is important to make use of certified
transport providers oriented to the adoption of quality as a
strategic decision for the organization, and international
regulations on issues of transport for pharmaceutical
products.
• To establish checklists, which allow the person in charge of
the inspection of vehicles within the organization, to check
the optimal condition, before and after the entry of the cargo.
Table 10 shows the main causes according to the cause
analysis categories, related to the second critical risk “Primary
packaging material failures”.
Table 10. Causes analysis for Risk “Primary packaging material failures”
Category Possible cause Observations
Methods No studies on Within the process of research and
packaging product development, before this is
performance in released to the market, transport tests
the development are not included to verify the behavior
stages of the materials during the same.
Methods No controls in during the manufacturing process
process for weight controls are carried out,
primary hardness, friability, particles, others,
packaging depending on the pharmaceutical form,
performance however, filtration tests to verify the
verification correct sealing of the product are not
part of the routine.
Materials Low material The chemical compatibility of the
compatibility materials has been demonstrated in the
stability studies; however, these studies
have not included in their tests the
physical compatibility of the
packaging materials to verify their
behavior over the lifetime product
packaging, it is proposed to include in-process controls to
detect failures before the product is shipped to the customer:
touch measurement, winery filtration tests, and waterproof
testing.
All the mitigation or elimination proposals must be included
in the ontology to take into account these in the future when
risks with similar causes will be identified.
5. Conclusions
The pharmaceutical sector is highly regulated, as products
that have a direct impact on consumer health are handled,
therefore it is recommended in the use of logistics suppliers
with experience in this field, which have the relevant
accreditations and follow good pharmaceutical storage and
transport practices.
It is recommended to involve the transport tests and product
filterability within the product development process, as this
allows, within the experimental batches to define the
suitability, not only of the chemical formulation and its
behavior in the time, but also the compatibility of the product
– packaging, packaging - packaging, and its behavior during
the storage and transport phases, where other types of variables
such as cargo vehicles, roads, atmospheric pressure changes,
intervention by regulatory entities, etc.
Operational risk management is very important to have a
unified language because it helps to information sharing about
both risks and actions to avoid or mitigate them. The Ontology
approach is a very powerful tool in this aspect.
Risks prioritization is a fundamental phase in operational
risk management because according to risk priorities
companies establish actions to manage them. FQFD
demonstrated that it is a powerful tool in the risk prioritization
process, especially when this prioritization considers the
strategic objectives of the company.
References

According to the causes previously identified, two actions
aimed at risk mitigation are proposed, which would solve the
three confirmed causes:
• It is proposed that, within these stability studies, in addition
to verifying the compatibility of materials in chemical terms
(pH, concentration, impurities, etc.), physical compatibility
tests should be carried out, for example, in cases where there
are relationships such as cap - pot, for liquid and semi-solid
pharmaceutical forms or aluminum-PVC, in case of solid
pharmaceutical forms. This to identify product filterability
during transport, i.e. the test would consist of packaging
experimental product and sending it with the corresponding
primary, secondary and designed packaging, to a ground
route, maritime and air, to identify whether factors such as
tracks, pressure changes, and material sealing, are affecting
the behavior of the same during storage and transport.
• In the case of the product that is already circulating on the
market, and did not have within their stability study physical
compatibility tests of their primary, secondary and tertiary
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