NEXT-GEN PHARMA 4.

0 INDUSTRIAL REVOLUTION: TRANSFOR-

MATION OF AMEND TO AMELIORATION WITH THE INCORPO-
RATION OF ADVANCED DIGITAL TECHNOLOGY AND FACILITA-
TOR OF EXISTING PHARMACEUTICAL QUALITY SYSTEM
Neelesh Malviya*a, Manisha Dherea, Sapna Malviyab
Smriti College of Pharmaceutical Education, Indore
a

ABSTRACT

of indirect and stochastic activity due to the amount of uncertainty and dependence that exists. The latest developments are the
industrial revolution of Pharma 4.0, which in particular has shown great potential for transforming the production base with advanced

business models of pharmaceutical manufacturing. The way these technologies are used in the journey from data collection to the
remarkable digital maturity of Pharma 4.0 will determine the progress of the next generation pharmaceutical production. Achieving the

To achieve these goals, the paper adopts an editorial organization that is widely used in manufacturing plants assessing dependence
from the whole system level to a detailed granular level of incoming material processes.
Keywords:

INTRODUCTION
pharmaceutical industrial revolution, subsequent biological materials from simple hand tools to commercially
changes have led to production, from water and steam machinery available machines that can crush, grind, assemble and compress
to automatic and digital production which makes the production large amounts of wood. The second industrial revolution was
process more complex, automatic and sustainable so that people
integration lines with pre-set controls that included basic automatic
[1]
The term
controls and process controls that gave producers the ability to
set basic process parameters. In the pharmaceutical industry,
as the new level of planning and control of a whole series of
this has been seen as electronic-based compression, grinding,
product life cycles, aimed at the ever-increasing customer needs. compaction and compression of the tablet that allows for greater
[2]
The main objective of Pharma 4.0 is to meet the needs of each production and importantly more careful monitoring of process
customer affecting areas such as order management, research and and quality. The third industrial revolution was made possible by
development, production authorization, delivery to the processing the development and availability of computers and communication
and recycling of products.[3] The main difference between pharma technologies, such as network computing, the Internet, and
wireless communication. This technology allows for a high degree
role of the individual in the manufacturing environment. Industrial of automation of processes and tools, which in pharmaceutical
4.0 or Pharma 4.0 plays an important role for the human worker in production empowers concepts such as continuous production
[4]
Pharma and effective control.
Paradigm 4.0 promotes communication of tangible objects such as
sensors, devices and business assets, both individually and online.
[5]
Design and writing methods in all disciplines should be reviewed
and their relevance assessed in a modern, multidisciplinary product
development framework and adapted to standard, integrated
and differentiated approaches, process and IT solutions.[6] The
production process is divided into a number of subunits that
share information that only processes sequential steps increasing

complexity.[7]

REVOLUTION OF PHARMA 4.0

If Pharma 4.0 is the future, then Pharma 1.0 is the beginning
of the modern medical industry. The use of herbal or botanical
preparations as medicines has covered the history of civilization.
Only in the last two centuries have we seen major changes in the
way things are processed and used for medical purposes. Pharma
Fig. 1: Pharma Industries Revolution
The interaction of human computers helped to create
complex control and high-quality products and processes. Remote
sensors and monitoring reduce the need for human workers on

Pharma Times - Vol. 54 - No. 12, December 2022 8


parameters and metrics. The fourth industrial revolution combines
state-of-the-art production technology to create integrated,
human involvement. The experience gained in the automated
and digital environment of Pharma 3.0 empowers the widespread
transformation into Pharma 4.0 in pharmaceutical production.
While Industrial 3.0 saw rapid development of individual operations
and tools, Pharma 4.0 promises the development of all production
systems and infrastructure. In such a case, performance data
business and operational decisions that directly affect production
outcomes. The advent of Pharma 4.0 forces us to visualize what
and how it could affect the performance of drugs and regulations.
There will be new operational paradigms due to digitalization,
automation and real-time data integration that should provide
better quality than six sigma in pharmaceutical production - in
both small and large molecular drug products. The COVID-19
public health emergency has highlighted the need for productive
technology that responds to the changing need and reduces
dependence on human intervention. For example, automated and
robotic operation may be necessary when dealing with limitations
of people working close to others. Here we will outline the future of
the pharmaceutical industry and the potential regulatory, technical
and operational challenges that need to be addressed in order for
the public to achieve the full potential of Industry 4.0.
The term Pharma 4.0 refers to the fourth industrial revolution
(AI), Internet of Things (IoT), robots and advanced computers to
dramatically transform the production environment. Pharma 4.0
is characterized by integrated, independent, and self-organized
production systems. New thinking will be needed to acquire
Pharma 4.0 pharmaceuticals and overcome current production
infrastructure, operations, and regulations. Although implementing
the advanced technologies and production methods required for
higher output power, improved production security, improved
reduction.
How Pharma 4.0 Technologies Could Be Deployed In
Manufacturing Of Pharmaceutical Product
Fig. 2: Deployed in manufacturing of pharmaceutical product
Integrated autonomous systems and robots combine real-
time and online data with industrial production processes and
external and internal information. For example, in pharmaceutical
production, external information that includes variables such as
supplier goods, patient experience, market demand and public
health emergencies may be combined with internal information
such as power and resource management, modeling and simulation
results, and laboratory data. Integrating internal and external data
sources enables responses, monitoring, control and forecasts that
have not been seen in real time. The result is a well-regulated, highly
connected, digital and priced chain of medicines to be produced.
NEED FOR PHARMA 4.0
o convert conventional equipment into self-discovery and self-
study equipment.
in a collaborative environment.
Pharma 4.0 aims to build an open, intelligent production
platform for an industrial network information application.[9]
Real-time data monitoring, product status and positioning and
adherence to production control instructions are the main
requirements of Pharma 4.0.[10]
CONCEPT OF PHARMA 4.0
The term ‘Pharms 4.0’ is often referred to as the fourth
revolution of the pharmaceutical industry and encompasses a
set of technological advances that have a profound impact on
the current industrial environment. At this stage, the Pharma 4.0
domain is analysed, with a future production vision enabled by this
new production paradigm. In addition, key elements in this concept
of disagreement have been introduced to better understand the
Fig. 3: Concept of Pharma 4.0
Background Of Pharma 4.0
Pharma 4.0 is a concept that has emerged over the years due
to technological advances and disruptive developments in the
an article published in November 2011 by the German government
as a result of the 2020 high technology strategy.[11] The concept
draws on previous ideas and ideas that emerged over the years. The
industrial climate has changed dramatically in the last few years
as a result of successive innovations and disruptive developments,
that took place centuries ago.[12]
improved productivity and efficiency using steam power, the
second allowed mass production using electricity while the third
Pharma Times - Vol. 54 - No. 12, December 2022 9

electronics and IT.
The fourth emerging industrial revolution, commonly referred to
as Industrial 4.0, includes rapid and disruptive changes that include
digital production, network communication, computer technology
and automation and many other relevant fields.[13] This new
industrial paradigm encompasses a set of technological advances,
companies that will use these technologies. In addition, Pharma
4.0 will lead to radical changes in the industrial and manufacturing
industries, have a strong impact on all price chains and offer a set
of new opportunities in terms of business models, manufacturing
technologies, new job creation and organization.
Future Manufacturing Vision
The future of productivity as predicted by Pharma 4.0 involves a
comprehensive integration of the universe, in which every producer
automatically exchanges information, triggers actions and self-
regulation. This method of production that aims to create intelligent
processes is characterized by small digital production networks
that operate without human intervention and automatically control
their operations according to the changes and needs of their
environment. The concept of Pharma 4.0 can be seen as a relatively
new approach that will integrate the digital and physical worlds.
Researchers and companies have differing views on the
concept and ideas of Pharma 4.0 but there is consensus on the
key factors that underpin future production vision: [14]
(i) Smart factory (ii) Smart products
(iii) Business models (iv) Customers
The term 'smart' comes in the middle of the Pharma 4.0
However, the possible meaning of this concept that meets the
opinion of a few authors can be associated with independent
and independent devices that can communicate in real time and
interact in a smart environment with other intelligent devices,
decision making and action-based actions. from the information
obtained.[15]
Pharma 4.0 is a new production concept that focuses on the
creation of smart products and processes, through the use of
smart machines and the conversion of conventional production
systems into intelligent industries. The Smart Factory is one
of the key drivers of this new industrial revolution, driven by a
number of developments including integration, digital production
These production solutions allow for the creation of an intelligent
environment throughout the value chain, allowing for the operation
new interconnected real-time connections between all production
equipment (sensors, actuators, conveyors, machines, robots, etc.),
of more complex market needs.
Intelligent products can be described as CPS because of
its ability to allow communication between the physical world
and the abstract world. These products are characterized by a
number of important features such as computation, data storage,
data storage about its production process and provision of
information on additional production and maintenance steps. In
addition, intelligent products have a high degree of autonomy,
Pharma Times - Vol. 54 - No. 12, December 2022 10
being able to detect and interact automatically with their physical
environment during its life cycle. Business models are heavily
a new way of communicating between supply chains. Business
modelling is changing over the last few years due to new industrial
and market demands and new business models are emerging,
allowing for the creation of collaborative environments. There are
many opportunities to improve processes for creating value and
integration with a value chain, in order to achieve the power of
self-organization and real-time integration and communication.
Customers are an integral part of every business model and
between value chains and enhances customer experience. The
high level of integration and exchange of independent information
will allow real-time needs to change. In addition, smart products
will provide relevant information to its users about their conditions
and usage limits. In short, smart factories are connected to a value
chain to meet market needs and integrate the integration between
machinery and construction materials through limited connections.
Smart appliances and smart products are tracked for the rest of
their lives, allowing for a high level of customization. Pharma 4.0
brings the emergence of new business models that better meet
the changing needs of customers, using real-time communication
capabilities throughout the supply chain.[16]
Micro Perspective For Pharma 4.0
The small concept of Pharma 4.0 presented in Figure 2 mainly
combines horizontal integration with direct integration between
intelligent factories but is also part of the end-to-end engineering
size.
The smart industry as a module for creating value at the highest
level of integration contains modules to create different values for
low levels of integration such as production lines, production cells
or production channels. Smart factories will use renewable energy
as an independent supply in addition to the supply provided by an
intelligent external grid.[17] That way the industry will be a power
supplier and consumer at the same time. A smart grid and a smart
factory power management system will need to be able to meet the
changing needs of power supply and response. The provision of
clean water to create value modules within a smart factory is also
consistent water pumps. Horizontal integration at a smaller point
design. Inbound and outbound goods from or to factories as part
half. point and destination. Autonomous transport vehicles such
as Guided vehicles (AGVs) will be used to identify indoor vehicles
creation modules for the integration of goods and products and
transportation systems. For this purpose, goods and products
contain identification systems, e.g. RFID chips or QR codes.
in the value chain. Direct integration with network production
creation: product, equipment and individual, and different levels
of integrating value-generating modules from production channels
through production cells and production lines to intelligent factories.
This interaction is between different levels of integration and
includes linking modules to create value and different functions of
a value chain, e.g. marketing and sales, service, purchase, etc.
 Fig. 4: Micro Perspective for Pharma 4.0
Factory pricing module is compatible with embedded Cyber-
Physical-System. Building materials, e.g. mechanical tools or
integration tools, which use sensor systems to identify and
locate value-generating features, such as products or people, Fig. 5: Opportunities for Pharma 4.0 in Manufacturing
and to monitor production processes, e.g. cutting, assembling, or
transport processes. Depending on the smart data monitored, the
actuators used in the building materials can respond in real time

and exchange of intelligent data between value-generating objects,

between quantitative modules and transport and between different
levels of integration with different value chain functions is done
through the cloud.[19]

Opportunities For Pharma 4.0 In Manufacturing

The key driving characteristics and requirements for most
day-to-day production activities across all industries are meeting
the objectives, quality, and cost while ensuring a safe working
environment for all. However, meeting these goals is becoming
product growth and sophisticated processes, high diversity of
customer demand and preferences, and constant pressure from
this hard-working climate faced by most manufacturers offers the
opportunity for unique AI capabilities in addition to standard tools
and methods. In particular, the common problem-solving task
that involves searching for root causes lends itself well to AI tools
that can detect and distinguish different patterns, indirectly from
hidden performance and performance data from a plant engineer.
Today, large amounts of continuously generated data are produced
by machines, sensors, controls, and staff records, etc. Data
can be categorized as follows: (1) location data collected by the
surrounding environment, e.g. power, (2) production performance
data recorded in control systems, e.g., time stamps or past time for
each component for each operating station, machine malfunction
time, starvation / blocking, idle time, and shift schedule, (3)
measuring or checking data from product quality tests, e.g.,
product range, form, and balance. Embedded in all of this big data
important indicators for solving complex problems while providing a
consistent understanding of the actual meaning of the parameters
in other visible aspects of the system or process. Combined with
the ability to comprehend high-resolution data, AAI provides the
ability to convert large amounts of complex production data into
practical and insightful information which has become common
in today's industry.[20]
Fig. 6: Pharma 4.0 Collaboration
Issues And Challenges In Pharma 4.0
The discovery of new technologies has led to the development
of the industry from the initial adoption of machine systems,
to modern automated assembly lines, to adapt and adapt to
changing market needs and requirements. Challenges such as
situations.[21] There are certain challenges and important issues
that arise during the implementation of Pharma 4.0 in the current
manufacturing industry are presented as
Wise Decision Making and Negotiation: In a smart production
system it requires more independence and community skills as
key components of self-planning systems while today’s system
has 3C capabilities i.e., a lack of independence in systems.[22]
High Speed IWN Protocols: The IWN network used today may
high-volume data transmission but is higher than the bizarre
network in the production area.[23]
Producing Large Accurate Data and Statistics: It is a
challenge to ensure the high quality and integrity of the
data recorded in the production system. Data companies’
incorporate different data repositories with different syntax
data analysis.[24]
System Modelling and Analysis: In system design, minimizing
dynamics and completing the appropriate control model,

Pharma Times - Vol. 54 - No. 12, December 2022 11

 systems should be modelled as an automated production
system. Research is still ongoing on a complex system.[25]
Cyber Security: With the growth of communication and the
use of standard communication protocols that come with
Industrial 4.0, the need to protect critical industrial systems
and production lines and system data from cyber security
threats is growing exponentially.
Modularized and Flexible Physical Artifacts: When working
and used together for distribution. There is therefore a need to
create a modular and intelligent transfer unit that can reshape
production lines.
Investment Issues: The issue of investment is a common
problem in many new technology-based campaigns in
in the industry.
Conclusions
Pharma 4.0 technology has the potential to transform the
robotic and computer-aided development. In particular, a series
of pharmaceutical supply, distribution, production processes
The smart industry of the future will take on unique features
road to full adoption of Pharma 4.0 will require development and
innovation dealing with large amounts of data, computer and
automated risks and challenges. Both industries and regulators
develop the skills to prepare intelligent production systems:
modelling and simulation, sensor systems, data management,
data analysis, computer engineering and control methods needed
to support autonomous systems, performance intelligence and
computer infrastructure. Business-level systems such as quality
management and training may need to be reconsidered. We
are beginning to identify known or hidden risks associated with
eventually develop regulatory frameworks that support Industrial
4.0. The adoption of the advanced production technology of
Industry 4.0 may pose a challenge to the current regulatory
framework, as many regulations were developed in the industry
2.0 standard mass production paradigm.
The integration of international controls will be instrumental
in encouraging the industry to embrace new production
technologies. The initial investment aimed at both capital and
operating costs of converting buildings or building new ones may
be barriers to entry for others. As with any investment, Pharma 4.0
may not offer immediate returns. However, the long-term value
of this new production concept should make the business issue
of adopting new technologies with more control, fewer errors,
more reactions, and fewer drug shortages. The biggest winner
of Industry 4.0 in pharmaceuticals, however, should not be drug
from high quality medicines with the most reliable supply chains
REFERENCES
1.
2.
3.
systems 2016; 2-7.
Pharma Times - Vol. 54 - No. 12, December 2022 12
4.
A Review of Research Issues and Application Examples. International
Journal of Automation and Technology 2017;11;4-16.
5. Sipsas K, Alexopoulos K, Xanthakis V, Chryssolouris G. Collaborative
approach. 5th CIRP Global Web Conference Research and Innovation
for Future Production, Procedia CIRP 55 2016;236-241.
6. Rennung F, Luminosu CT, Draghici A. Service Provision in the Framework
Social and Behavioural Sciences 2016;372-377.
7.
Aerospace, Indus
Lee J, Kao HA, Yang S. Service innovation and smart analytics for
Industry 4.0 and big data environment, Product Services Systems and
Value Creation. Proceedings of the 6th CIRP Conference on Industrial
9.
10. Almada-Lobo F. The industry 4.0 revolution and the future of
11.
12.
modeling to predict pharmacokinetic parameters of severely ill patients.
Adv. Drug Deliv. Rev. 2003; 55(9):1233-1251.
13.
warfarin dose optimization. Pharmacogenomics 2016;17(2):121-131.
14. Shimizu H, Yasuoka K, Uchiyama K, Shioya S. Bioprocess fault
15.
network modelling of continuous wet granulation using a twin-screw
extruder. Int. J. Pharm. 2017;521:102–109.
16.
and high-dimensional visualization in cancer detection, diagnosis, and
management. Ann. N. Y. Acad. Sci. 2004;1020:239-262.
17.
19.
network and curve estimation in pharmacokinetics of losartan in rabbit.
20.
manufacturing: from batch to continuous production. J. Pharmaceut.
Innov. 2015;10(3):191-199.
21.
open innovation in the pharmaceutical industry. Drug Discovery Today
2013;23-24:1133-1137.
22.
network analysis for predicting human percutaneous absorption taking
account of vehicle properties. J. Toxicolog. Sci. 2015; 40(2);277–294.
23.
Sci. Eng. 2020;142(11):16.
24. Ekins S. The Next Era: Deep Learning in Pharmaceutical Research.
Pharm. Res. 2016; 33(11),2594-2603.
25.
Biochem. Eng. Biotechnol. 2013;132:35–63.