COLLEGE OF BUSINESS AND ACCOUNTANCY - ENTREPRENEURSHIP DEPARTMENT

PHARMACEUTICAL INDUSTRY:
DRUGS / MEDICINE

Presented to the Faculty of Quezon City University

San Bartolome, Novaliches Quezon City
1st Semester, Academic Year: 2022-2023

In Partial Fulfillment of the Requirements for the Degree

Bachelor of Science in Entrepreneurship

By: SBENT_4H
Alcazar, Rey Ann P.
Caguete, Ira Jelly T.
Catarina, Cherry Ann S.
Caubat, Rizza Y.
Egoc, Rogen B.
Jazarino, Eden E.
.Gallego, Flomie Ann P.
Palermo, Reygeen S.
Torres, kissy Pearl F.
Yacap, Lara Joy M.

PROFESSOR:
MR. EMMANUEL GARCIA

OCTOBER 2022

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BRIEF HISTORY OF PHARMACEUTICAL INDUSTRY

The roots of the pharmaceutical industry lie back with the apothecaries and pharmacies
that offered traditional remedies as far back as the middle ages, offering a hit-and-miss
range of treatments based on centuries of folk knowledge. But the industry as we understand
it today really has its origins in the second half of the 19th century.

Whilst the scientific revolution of the 17th century had spread ideas of rationalism and
experimentation, and the industrial revolution had transformed the production of goods in
the late 18th century, the marrying of the two concepts for the benefit of human health was a
comparatively late development. The 2010s have seen the development of innovative new
classes of medicines, building on the greater understanding of the body since the genome
was first sequenced at the end of the last century. This knowledge of genetics and the
underlying cause of many diseases, including cancer, has resulted in powerful new drugs.

While the industry has made huge achievements in some areas, research into new
antibiotics has stagnated as they do not create the revenues big pharma companies are
looking for – and this comes at a time when the world is still coming to grips with the scale
of the threat from antimicrobial resistance.The future is bright for the pharma industry, but
maintaining public trust and preventing millions of deaths from antibiotic resistant bacterial
strains are two major challenges it must overcome as the century progresses.

DRUGS

A drug is a substance that when consumed by an organism causes a physiological or

psychological change. An organism is a living being. We, for example, are organisms, as are
other animals, bacteria, plants, and anything else that lives.

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TABLE OF CONTENTS

Page

TITLE PAGE i

HISTORY OF PHARMACEUTICAL INDUSTRY ii

TABLE OF CONTENTS iii

PHARMACEUTICAL INDUSTRY 5

A. BIG DATA AND ANALYTICS 5

1. Definition 5
2. Importance 5
3. Uses of Big Data 5
4. Utilization in Pharmaceutical Industry 6

B. CLOUD COMPUTING 8

1. Definition 8
2. Importance 8
3. Utilization in Pharmaceutical Industry 8

PFIZER INC 9
A. History 9
B. Classifications 9

1. Classification of Manufacturing Industry 9

2. Classification of Products 9

C. Manufacturing Operations Management 10

LEAN MANUFACTURING 11

A. Designing Manufacturing Process 11

1. Eliminating Waste 12
2. Deliver Process Improvements 12
3. Lean Six Sigma 13

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HOSHIN KANRI 14

A. Deming Cycle 14

1. Plan-Do-Check-Act 14
2. Relationship of Deming Cycle in Pharmaceutical Industry. 14
3. Adaptation of Deming Cycle 15
4. Distribution of Medicine 15
5. Chain Process 15

INVENTORY MANAGEMENT 16

A. Pharmaceutical Inventory System 16

B. Key Benefits of Pharmacy Software 16

1. Identifies Expired Items 16

2. Maintain Separate Registers/Folders. 16
3. Patients' Medical History 16
4. Barcode Labels 16
5. Automatic Delivery 16

C. Features of Pharmacy Inventory System 17

1. E- Prescription 17
2. SMS and Alerts
3. Multi Store and Multi-Location Support 17
4. User Management 17
5. Expiration Management 17
6. Re-Order Management 18
7. Reporting 18

DELIVERY PERFORMANCE. 19

SMED 21
A. Change Over 22

STAGES OF SMED 22
A. Classification of Medicines 24

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PHARMACEUTICAL INDUSTRY

The pharmaceutical industry discovers, develops, produces, and markets drugs or

pharmaceutical drugs for use as medications to be administered to patients (or self-
administered), with the aim to cure them, vaccinate them, or alleviate symptoms.
Pharmaceutical companies may deal in generic or brand medications and medical devices.
They are subject to a variety of laws and regulations that govern the patenting, testing,
safety, efficacy using drug testing and marketing of drugs.

Big Data and Analytics

Big Data is defined as an information asset with high volume, velocity, and variety, which
requires specific technology and method for its transformation into value. Big Data is also a
collection of information about high-volume, high volatility or high diversity, requiring new
forms of processing in order to support decision-making, discovering new phenomena and
process optimization.

Importance of Big data to Pharma

The primary goal of Big Data in the pharmaceutical industry is to assist companies in
making informed decisions related to business operations. Companies can make informed
decisions by examining a huge amount of data collected from a variety of sources, including
retailers, doctors, and patients, to name a few.

How does Big Data and Analytics used in Pfizer?

Pfizer works with innovative research partners across a range of disciplines to improve the
quality, speed and productivity of clinical research. Using digital tools, new ways of
collecting data and expanding access through diverse partnerships, Pfizer is developing
breakthroughs that change patients’ lives faster than ever before.

a. Digitizing Clinical Trials

Pfizer is using automation, artificial intelligence and predictive analytics to
modernize, streamline and simplify the development of medicines. Vast
quantities of data can be collected and analyzed with great precision, reducing
the risks of error and speeding the drug development process. Other
advancements in  remote data collection—including wearable devices and
mobile apps—are making it more convenient for people to participate in
clinical trials.

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b. Data Outside Traditional Clinical Trials

       Pfizer is using real-world evidence (RWE) to find new or expanded uses for our
medicines. This includes using data from electronic health records, registries and insurance
records, to paint a more holistic picture of how a new medicine could impact patients’ lives.
Real-world evidence can help improve both the design and execution of clinical studies and
in some cases, answer important clinical questions without the need to enroll new
participants into a clinical study. This is particularly important when traditional trials alone
do not provide sufficient data.

Utilizing Big Data in the Pharmaceutical Industry

Big data can be beneficial in the pharmaceutical industry due to the following applications:

i. Research and Development

The introduction of big data in the pharmaceutical industry will help business
leaders gain insights about various drugs and their usage.

ii. Clinical trials

Big data can help recruit patients using data such as genetic information,
personality traits, and disease status. 

iii. Drug Discovery

By leveraging big data in the pharmaceutical industry, researchers can utilize

predictive modeling for drug discovery.

iv. Drug Reaction

Pharmaceutical companies can mine social media platforms and medical forums
for ADRs and patient reviews.

v. Precision Medicine

Big data can be the key enabler of precision medicine, where diagnosis and
treatment of disorders are carried out using relevant data about a patient’s
genetic make-up, environmental factors, and behavioral patterns. 

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vi. Sales and marketing

The advent of big data in the pharmaceutical industry will allow business
leaders to analyze large volumes of data about customer behavior, the impact of
ad campaigns, and customer retention.

vii. Collaboration

To reap the benefits of big data in the pharmaceutical industry, business leaders
need to develop an effective adoption and implementation strategy.

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CLOUD COMPUTING

Cloud computing is the on-demand availability of computer system resources, especially

data storage and computing power, without direct active management by the user. Large
clouds often have functions distributed over multiple locations, each location being a data
center.

Importance of Cloud computing to Pharma

The Pharma industry is one of those industries that produce and process a large amount of
data almost daily. The data comes in all forms, clinical tests, and product research, and
market analyses. The clinical tests alone produce a large amount of information, crucial for
future research. By using cloud computing in the pharmaceutical market, the companies in
this sector can make their data management process easier and more efficient. The method
reduces overall cost and provides pharmacists with real-time access to data which the on-
going tests would generate simultaneously.

Utilization: Cloud Computing Speeds Up The Drug Discovery Process.

The research and development of a single drug can span over many years and Cloud-based
high-performance computing will help researchers access virtually unlimited storage and
computing resources that can help organize resources and guide initial surveys.

Cloud Computing Enables Seamless Collaboration

In such cases, the cloud can help companies come together to share a common platform
while keeping their independent data safe and secured. Thus, cloud computing in the
pharmaceutical industry enables a quick, efficient and secure way to deliver the value of
their work. 

Cloud Computing Ensures Secure Data Sharing During Clinical Trials

The solution is to bring clinical trial management into the cloud computing infrastructure.
Having one centralized “console” in the cloud from which to query, receive and archive
feedback vastly speeds up the clinical trial process. It also helps researchers aggregate
clinical data and analyze them at the granular level. Thus, cloud computing in the
pharmaceutical industry for clinical trials ensures professional-grade security and discretion
of valuable collaborative input. 

Cloud Computing Supports Pharma Marketing Operations

Implementing cloud computing in the pharma industry also maximizes cost efficiency,
improves communication among marketers, and optimizes the digital media spend that
could save millions of dollars. This is how cloud computing in the pharmaceutical industry
supports marketing operations.  

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BRIEF HISTORY OF PFIZER INC.

Pfizer Inc. is one of the leading companies in the pharmaceutical industry along with
the biotechnology industry. The business was established in 1849 by Charles Pfizer and
Charles F. Erhart, two cousins from Germany. In Brooklyn, New York, operations were first
centralized. Pfizer Inc., with its headquarters on 42nd Street in Manhattan, New York City,
United States, is now led by Albert Bourla. The company is involved in developing and
manufacturing prescription medications for patients all around the world. Pfizer Inc.
consists of professionals devoted to finding cures for various diseases. They are committed
to producing medicines to protect people against illnesses. Every medicine will keep their
bodies healthy and help people to continue living.

Pfizer Inc. uses science to improve the lives of people suffering immunological,
cardiovascular, and neurological illnesses. The company's scientists do ongoing research to
develop its pharmaceutical products. It is to ensure that their medicines are effective and
high-quality products. The company now concentrates its innovation efforts on oncology,
vaccines, anti-infectives, inflammation and immunology, internal medicine, and rare
diseases. The Pfizer-BioNTech COVID-19 vaccine, also known as Comirnaty, is the
company's well-known product, and in 2021 it earned about 36.8 billion dollars. Pfizer Inc.
continuously produces vaccines to be distributed globally to protect people against the risk
of COVID.

Classification of Manufacturing Industry and Classification of Products

Pfizer Inc. belongs to the manufacturing industry and is classified as a large

industry. The manufactured products of Pfizer Inc. are considered as consumer products
which consumers purchase to consume since their pharmaceutical products are effective,
safe, and high quality. The company has 39 manufacturing sites worldwide. There are 125
different countries where they sell pharmaceutical products. In 2021, the company’s revenue
amounted to $ 81.29 billion. The highest percentage of that revenue is from the United
States, and the rest came from other countries. As of now, the total number of employees
globally is 79,000 in 2021.

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Manufacturing Operations Management

Pfizer Inc. is using digitization in its supply chain to adapt to the rapid changes in
the pharmaceutical industry. The company created their own Portable Continuous Miniature
Modular (PCMM) manufacturing platform that helps in improving their manufacturing
process. The production of pharmaceutical products is faster than ever before, which means
from weeks to minutes. The platform also lowers the cost of producing pharmaceutical
products and retains its high quality standards. The PCMM manufacturing platform is a tool
for increasing company productivity and ensuring that they can produce quickly for the
benefit of people.

In addition, the Highly Orchestrated Supply Network (HOSuN) was launched in

2015 by Pfizer Inc. It is an innovation for the improvement of the company's global supply
chain. The HOSuN is used to monitor the current demand status of products across the
world. It is efficient for the company in order to have proper demand information, which is
useful since there are medicines that take months to be produced. The demands will be met
and the sufferings of people will be solved. Pfizer Inc. is constantly researching for
innovations in their processes, which allow the company to manufacture efficiently in order
to improve the lives of other people.

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LEAN MANUFACTURING

Designing Manufacturing Process

Global pharmaceutical companies are borrowing "lean" manufacturing principles,

which have long been used in other industries, to reduce the time and money it takes to
release their products. Lean manufacturing is essentially removing non-value adding
activities or waste from the production system.

The relevance of the Lean approach to pharma is at first most evident when applied
to manufacturing. In high-value areas where one output becomes an input for the next phase
of the process, streamlining, standardization, and cross-functional coordination offer a
solution to chronic problems such as long cycle times and excess inventory. By
standardizing processes and platforms, Lean efforts can increase the productivity, efficiency,
and flexibility of a global supply network. Lean programs aim to optimize global capacity
and inventory while ensuring an uninterrupted supply of needed medicine.

Lean can help drug companies do far more with fewer resources. It can also engage
and transform the pharma culture in far-reaching ways. These changes won't happen
overnight, though it took Toyota 50 years to refine its Lean production system. Pharma
doesn't have that luxury of time, but ambitious, persistent companies with a clearly defined
business system can get it right a lot faster than that and the payoff will be worth the pain.

Pharmaceutical companies continually strive towards innovative new treatments

that help people live longer and healthier lives. These therapies are developed,
manufactured, marketed and distributed around the world by pharmaceutical companies
every day. Here, we look at some of the key contributions of the industry, and the reasons
why pharmaceutical companies are so important to patients, society and the life sciences
industry.

Pharmaceutical manufacturers are under constant pressure to fast-track innovation

and increase the speed at which they introduce successful drugs to market. Various scientific
advances are fueling a fresh wave of pharmaceutical manufacturing innovation. These
advances are supported by the U.S. Food and Drug Administration (FDA), which is helping
accelerate the industry’s throughput of lifesaving medicines and therapeutics by taking a
more pragmatic approach to regulation.

In recent years, ownership and management of the means of production are shifting
from larger pharmaceutical companies to contract manufacturing and contract development
organizations.Drug companies like Pfizer are increasingly using contract partners
strategically to fill capacity and expertise gaps to produce their branded drugs. 

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Having a strong manufacturing partner, it is hoped, will help them better manage the costs
and risks of development, quality control, and regulatory compliance more effectively.

How does the Pharmaceutical Industry eliminate waste? 

Pharmaceutical manufacturers are being compelled to reduce waste in their

production processes by challenging economic conditions, international competition, and
laws that raise the environmental obligations of chemical companies. Some businesses make
an effort to keep garbage out of landfills, while other businesses concentrate on a zero-waste
plan. This approach aims to eliminate waste whenever possible and reduce or reuse it in
other contexts rather than just reducing the amount of garbage going to landfills. Rising
commodity prices provide us with a chance to consider waste as both a limited resource and
a potential concern. Thus, executing a zero-waste plan can be considered a key business
imperative rather than just a choice. In the past, it has been common practice to reduce
waste by recycling, reusing, or repurposing things as well as by turning them into energy.
The systematic methodology also finds cost-saving opportunities and potential
improvements in the waste material collection, handling, and packing.

Some pharmaceutical corporations run their own on-site garbage disposal or waste
treatment facilities, and some keep a fleet of waste vehicles on the road. The majority of
pharmaceutical companies that carry out these activities have scaled back their operations or
intend to do so soon because funding these services can be a financial burden. Maintaining
waste-treatment operations may not only yield a poor return on investment, but it may also
be incongruent with the objective of eliminating waste.

In order to find possibilities and solutions for execution, an effective environmental

action plan needs a thorough review. A comprehensive zero-waste approach can lower
environmental hazards while providing economic benefits.

How does the pharmaceutical industry deliver process improvements? 

To ensure the health and safety of patients, the pharmaceutical sector must adhere
to strict quality and safety standards. Baumer UK provides dependable and potent industrial
cameras as well as user-friendly sensor systems for the highest level of product quality and
defense against counterfeiting. For the pharmaceutical sector, these solutions provide quality
and process control, from manufacturing to packaging and shipping.

To improve the customer experience, processes can be streamlined. Creating

processes that are more effective will lead to better bottom-line results. To cut costs and
waste, shifting from defect detection to defect prevention Processes should be standardized
throughout the production division.

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To remove barriers in the manufacturing process, process improvement

necessitates and enables personnel to better grasp the current status of how a process runs.
Each pharmaceutical product or service is the end result of a process that involves learning
the skills necessary to eliminate waste, duplication of effort, or inefficiency in order to
support the crucial growth of an organization and its production process.

Employees and industrial processors can minimize waste and production

downtime through continual process improvement. This can be accomplished by putting a
Lean Six Sigma process in place.

Lean Six Sigma

Lean Six Sigma offers a methodical technique to assist staff in developing their problem-
solving abilities to create a strong problem-solving culture within organizations, providing
advantages across the board for industrial applications. Because of this procedure, "finding a
better approach" becomes a daily task to maintainable enhance procedures inside the
Pharmaceutical Industry.

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HOSIN KANRI

The Deming Cycle is a four-step iterative problem-solving method used to enhance

organizational procedures. Its full name is Plan-Do-Check-Act (PDCA). It encourages
continual improvement based on a strategy or plan that is put into practice, thoroughly
considered, and then assessed.

Plan:
Investigate the scenario as it stands in this stage to comprehend the nature of the issue at
hand completely.

Do:
to determine the true issue by doing a data analysis, creating a solution plan, and putting it
into practice.

Check:
must keep an eye on the results of the execution strategy and, if necessary, find
countermeasures to further enhance the solution. After finishing, conduct a second check to
address any achievements and shortcomings and to allow for future improvements based on
the lessons learned.

Act:
Put your suggestions and solutions into action. Determine the effectiveness of the remedy,
and then either adopt it into regular work procedures or discard it.

Relationship of Deming Cycle in Pharmaceutical Industry.

In  pharmaceutical  industries,  they  have  to follow  several procedures  in  order  to
maintain  their  high  quality  of  the products. The guidelines known as Good
Manufacturing Practices are adhered to by all pharmaceutical firms (GMP). GMP is
essential in the pharmaceutical sector to guarantee that production is conducted in a safe and
healthy manner. GMP also keeps an eye on the production of pharmaceutical and food
products to make sure everything is in order and under control. 

As the Covid-19 pandemic arises in different areas of the world many

pharmaceutical industries are producing and searching for the ideal vaccinations that can
eliminate the Covid-19 virus as it spreads over the world in different regions. Time goes by
and different vaccines were introduced but the virus continues to evolve and develop new
forms and different variants. And that appears to be the problem facing each pharmaceutical
company that developed a vaccine. And one of the pharmaceutical companies to release and
introduce its vaccine is Pfizer.

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How is Pfizer able to adapt and how does the deming cycle / PDCA help their R&D?

With expertise and technological skills in Basic Research, early CMC Development,
Clinical Development, Clinical Serology and Diagnostics, and Operations, Pfizer R&D is a
fully integrated, international operation that develops assets from discovery through
registration and beyond. Pfizer Vaccine R&D places an early emphasis on end-to-end design
of vaccine production processes. To create scalable processes from program inception
onward, professionals take into account both vital biological features and strong engineering
and manufacturing principles."Pfizer continues to study novel conjugation and carrier
systems in Vaccine R&D to generate a better immune response."

Pfizer is committed to look and produce a vaccine that can help everyone fight
against COVID 19. They used PDCA (plan, do, check, & act) to monitor their progress in
R&D. As they tried different methods and combined different chemicals or formulas to
bring out the best vaccine to fight the virus. 
Plan: They conduct an investigation and evaluate the sample of the virus and the outdated
vaccine that was applied in a related virus case.
Do: The Pfizer R&D team should pinpoint the issue or the vaccine's shortcomings and make
necessary improvements.
Check: After finishing their work on a potential vaccination, they move on to testing it.
Act: As they monitor the vaccine's development, they go on to the next step, which is very
important and dangerous since it will show whether the vaccine is actually effective and
capable of battling the virus in some way.

How Pfizer handles the distribution of their medicines?

Pfizer continuously and actively monitors the flow of their medications. With more
than 200 suppliers globally and more than 40 Pfizer-owned locations, they operate one of
the most modern supply chain management systems in the industry, offering capacity and
redundancy when needed. The production and supply chain teams at Pfizer have been
working constantly to ensure that patients continue to have access to the world's supply of
their medications. They created an extraordinary and comprehensive contingency strategy in
order to keep control over the activities of their location, and also make use of cold chain
procedures.

How is Pfizer utilizing a cold chain process to distribute its vaccine?

"We have developed packaging and storage innovations to be fit for purpose to meet
the needs of our global network. We have specially designed, temperature-controlled
thermal shippers utilizing dry ice to maintain recommended temperature conditions for up to
10 days unopened. The intent is to utilize Pfizer-strategic transportation partners to ship by
air to major hubs within a country/region and by ground transport to dosing locations."

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INVENTORY MANAGEMENT

Pharmaceutical Inventory System

A pharmacy inventory system, also known as pharmacy management software, stores data
and systemizes and controls the medication process at the pharmacy. As time goes on,
healthcare technology advances in order to automate healthcare management.

Using pharmacy software systems, an inventory system for pharmacies allows for the
control of medicine stock and the selection of the appropriate medicine. A pharmacy
inventory system can help a pharmacist improve pharmacy management services. Patients
prefer pharmacies to doctor's visits for minor illnesses, and a pharmacy management system
can prescribe over-the-counter medications. The automated inventory system pharmacy
improves medication management and automates drug delivery.

Key Benefits of Pharmacy Software

A pharmacy system allows pharmacists to run their businesses more efficiently by providing
integrated care services.

Identifies Expired Items: Because it does not generate bills for expired products, a
pharmacy stock inventory system is an excellent way to manage pharmacy operations. A
pharmacy inventory control system alerts the store owner to expired medications and assists
the store owner in purchasing new items in a systematic manner.

Maintain Separate Registers/Folders: A pharmacist can keep a separate register that

contains information about all the drugs that are stored in a pharmacy folder. This keeps
track of the composition of medicines and informs the user of available substitutes, which
can be life-saving in an emergency.

Patients' Medical History: A hospital pharmacy inventory management system can

enable store owners and pharmacists to monitor the patient's treatment in accordance with
the safety standards that have been established. A standardized pharmacy inventory system
allows pharmacists to access and review patients' medical histories.

Barcode Labels: All products are given a barcode label before being distributed to
pharmacies and stores. Using the most recent pharmacy software, an automated inventory
system pharmacy promotes automated medication labeling and printing expiry dates of
medicines. In addition, the pharmacy inventory system aids in calculating the number of
labels required.

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Automatic Delivery: One of the most intriguing features of pharmacy inventory

systems is the ability to automatically assign orders to various distribution channels. This is
determined by the item's supply date and the number of days required to deliver the order to
the customer via pharmacy inventory management software.

7 Features of Pharmacy Inventory System

1.        E- Prescription

It is an essential feature of a pharmacy inventory system that provides patients with a

user-friendly option and reduces errors. To manage refills, pharmacies can use the electronic
prescription feature of prescription management software. It also enables doctors to send
new refills directly into pharmacy operating systems, allowing for faster medication
dispensing. In a pharmacy database management system, e-prescription analyzes data and
eliminates all confusion in delivering the correct prescription medicines.

2.        SMS and Alerts

Pharmacists can use electronic pharmacy systems to send text messages to patients
notifying them when their prescriptions are about to expire. Patients can then let the
pharmacist know if they need a refill by responding to the message sent by pharmacy
inventory software. It improves practice management as well as patient engagement. The
status updates allow pharmacists to stay in touch with patients, increasing patient
satisfaction.

3.        Multi Store and Multi-Location Support

This pharmacy inventory software feature enables users to manage stores in multiple
locations using a prescription management system. It allows hospitals to view data and
exchange electronic data on stock levels, sales, and returns from multiple stores in a single
inventory management software. A hospital inventory management software generates
detailed reports for the entire chain of stores, providing the user with a comprehensive view
of profit, loss, stock levels, and so on.

4.        User Management

User management in pharmacy management solutions allows different users to have

different levels of access. Access to various features of pharmacy management software
may be restricted for different users in order to implement simple management.

5.        Expiration Management

Expiry management is a required feature for integrated pharmacy management

solutions. Expired products can cause huge losses for pharmacies. Medicines are typically
purchased in bulk in any pharmacy, with varying MRPs and expiry dates. As a result,
pharmacists may lose track of each medicine's expiry date and mistakenly keep it on the

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shelves. This can be avoided by incorporating an expiry management feature into a

healthcare pharmacy management system. It can alert pharmacists to near-expiry
medications, which they can sell or return to the supplier.

6.        Re-Order Management

Expiry management is a required feature for integrated pharmacy management

solutions. Expired products can cause huge losses for pharmacies. Medicines are typically
purchased in bulk in any pharmacy, with varying MRPs and expiry dates. As a result,
pharmacists may lose track of each medicine's expiry date and mistakenly keep it on the
shelves. This can be avoided by incorporating an expiry management feature into a
healthcare pharmacy management system. It can alert pharmacists to near-expiry
medications, which they can sell or return to the supplier.

7.        Reporting

The reporting feature of the cloud-based pharmacy inventory system provides

valuable insights into pharmacy operations. Pharmacies deal with a large number of patients
on a daily basis and have large amounts of health informatics stored in the pharmacy's
computerized inventory system. Data in a pharmacy inventory system can be used to
improve business strategy or to aid in the certification or inspection process.

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10 WAYS TO IMPROVE EFFICIENCIES IN THE PHARMA SUPPLY CHAIN

1. Cutting out the middle man (wholesaler.) This will do three things:

1) Speed up the distribution process as the company will be delivering directly to the
customer.
2) Cut costs by cutting out the middle man.
3) Sell more product: with better prices the companies will be more competitive and
outsell competitors.

2. Improvements in tracking product, which will cut down  counterfeits and competitors
copying products. This will help the pharmaceutical companies to stay ahead of the
competition and be more efficient.

3. Improve technology in the manufacturing process. This will help:

1) The products to be created quickly and efficiently.

2) Better technology will help product cost to be reduced and sold at a more
competitive price. This will ensure dominance over competitors.
3) Upgrading manufacturing equipment and processes to make manufacturing product
more efficient.

4. Shift manufacturing outsourcing to new markets like India and China. This will cut costs
as labour is cheaper here and products can be made more cost effective. When this is done it
will allow pharmaceutical companies to be more competitive and cut costs in the
manufacturing of their products.

5. Quality Control will be increased. This will ensure better quality products. Sales will
increase with improved quality. There will be less wastage from substandard product that
cannot be sold. When proper analysis of the quality of a product is done it can save
disastrous recalls that hurt the company and can cost a substantial amount of money. With
the pharmaceutical Industry there is little room for mistakes and substandard product as
peoples’ lives can be at risk. Additionally the industry itself is highly competitive and sub
quality product can mean that contracts will move to competitors.

6. Analysing how money is being spent and where it is going is a factor. In order to cut costs
an initial financial analysis must be done. It will then be possible to know where to cut costs
and how to make budgeting better.

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7. Cutting costs in areas where there is wastage and money is not being used efficiently.
There are always areas in any company that are not working as efficiently as they could.
Too much money can be squandered in places where less investment would be equally
effective.

8. Supply chain analytics should be done. What do we mean by this term? It is when a
company scrutinises their whole supply chain process. They can assess which areas it needs
to be improved and made more efficient. The supply chain itself is quite a complex affair.
The management are dealing with several suppliers and working on a global basis. This
makes supply chain analytics quite hard to do. Questions need to be asked in order to
analyse the supply chain correctly:

1) Examine which suppliers are the best and most efficient: some suppliers are better
than others. The more efficient the suppliers are the better the supply chain will
work.
2) Impaction of different factors can affect the Supply Chain. The impact of various
elements like weather or the rise and fall of fuel prices on the delivery system will
affect cost of supply.
3) How much inventory to keep for certain products. This is to do with accurate
analysis of supply and demand. Over stocking can cause wastage and force
companies to lower prices to get rid of old stock, in order to prevent heavy losses.
Under stocking can incur losses as the company will need to back order and
sometimes need to compensate the customer for waiting. Worse scenario is the fact
that customers can go to competitors to get their order done on time, rather than
wait for the back order.

9. Once supply chain analytics have been conducted the pharmaceuticals company can then
apply the necessary changes needed to increase efficiency and cut costs in the supply chain.

10. Examining the purchasing team in the company. The company must ensure that they are
getting product of high quality but at the same time not spending too much on product from
the suppliers. This may mean that they need to change suppliers to get better prices but still
maintain quality. It is important to get detailed data from the purchasing section of the
company, to make the process more efficient and cost effective.

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SMED

The pharmaceutical industry over the last decades has developed, significantly increasing
the performance achieved by its products. In particular, it has diversified and globalized,
while at the same time it is seeking to reduce production costs. Nevertheless, rigorous
quality controls and extremely detailed specifications must be respected, not only by
increasingly demanding and rigorous external bodies, but also by the industry itself, which
itself applies very precise specifications with little margin for errors. 

This main theme gave rise to the elaboration of this Master's Dissertation in Chemical
Engineering, which was held at the premises of Generis Pharmaceuticals and whose main
focus is the application of SMED in the productive process of compression.In this way, this
work intends to solve problems observed during the product changes and to improve the
current setup times, followed by the elaboration of an operative way for the product changes
for each equipment under study, so that the tasks are normalized and consolidated leading to
the training of operators.Consequently, it is necessary to determine the optimal standard
time for the change of each machine.

The primary focus of the SMED methodology is on the reduction of setup times. The setup
consists of the exchange of reference in production, in a machine or in a series of
interconnected machines, by the exchange of parts, tools, molds and / or grips. The setup
time is thus limited to the period between the production of the last part of the output
reference and the production of the first part, with quality, of the input reference.

The SMED methodology is applied in the field obeying a structure divided in 5 fundamental
stages, in which several techniques are implemented in order to reduce internal and external
setup times. Internal setup corresponds to work that can only be done while the machine is
stopped. The external setup refers to all other activities that can be performed with the
machine running, either before or after the stop.

●Study of the current situation - It is executed in conjunction with the whole team, a
detailed analysis of the current method is performed, of all the tools used as well as all the
movements performed.

● Separate internal work from external work - Using the data collected in the previous
analysis, a separation of all internal work (work that can only be executed with the machine
stopped) from the external work is done (work which can be done with the machine in
motion). External tasks are all grouped at the beginning or end of the process and are
reorganized according to a new operational normalization.

● Convert internal to external work - After a detailed analysis of all internal work, modes
are evaluated, through improvements and developments in the tool or process of
transforming internal tasks into external tasks.

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● Reduce internal work - in this step the main goal is to reduce the time of internal tasks,
using tool normalizations, reduction of adjustment times and settings in fast grips.

● Reduce external work - In the last step, the time of external operations is reduced, using
the 5S (another tool of the Lean methodology that constitutes a visual technique of storage
that contributes to the good state and functionality of all locations to the standardized
preparation of changes and tools to support change. 

CHANGE OVER

SMED approach helps the pharmaceutical company to eliminate unwanted activities and to
externalize and reduce the internal activities by simplification or standardization. The
application of other tools, such as 5S and Kanban tool-kits, allowed the company to
optimize the process and reduce the standard deviation of the changeover times. Good
manufacturing practice (GMP) procedures of the pharmaceutical sector limit the conversion
of internal setup elements to external setup elements.

7 STAGES OF SMED: 

1. The increasing level of market competitiveness contributes to a continuous change

in demand, which forces companies to become more competitive in order to adapt quickly
to new challenges. In view of the concern to reduce costs and eliminate waste, despite all the
technological innovations in production and information, process automation and all the
training of its employees, companies continue to confront with service-level problems,
which naturally have a negative impact on the degree of customer satisfaction, and may
ultimately lead to their loss. 

2.  The external setup refers to all other activities that can be performed with the
machine running, either before or after the stop.
●Study of the current situation - It is executed in conjunction with the whole team, a
detailed analysis of the current method is performed, of all the tools used as well as all the
movements performed. 

● Separate internal work from external work - Using the data collected in the previous
analysis, a separation of all internal work (work that can only be executed with the machine
stopped) from the external work is done (work which can be done with the machine in
motion). External tasks are all grouped at the beginning or end of the 3 process and are
reorganized according to a new operational normalization. 

● Convert internal to external work - After a detailed analysis of all internal work, modes
are evaluated, through improvements and developments in the tool or process of
transforming internal tasks into external tasks. 

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● Reduce internal work - in this step the main goal is to reduce the time of internal tasks,
using tool normalizations, reduction of adjustment times and settings in fast grips. 

● Reduce external work - In the last step, the time of external operations is reduced, using
the 5S (another tool of the Lean methodology that constitutes a visual technique of storage
that contributes to the good state and functionality of all locations to the standardized
preparation of changes and tools to support change. 

3. Generis Farmacêutica, S.A. is a pharmaceutical industry whose main objective is to

develop, manufacture and commercialize generic medicines. It started a generic promotion
and marketing activity in June 2002 , with a manufacturing unit in Portugal, located in
Venda Nova, Amadora council, with a production capacity of 30 million units. With the
commitment to develop, produce and commercialize generic medicines of the highest
quality at an affordable price, Generis has in its portfolio more than 200 APIs, one of the
most relevant arguments of its value proposition. 

4. In Generis there are three types of cleaning, the following denomination was adopted by
the company itself, the smaller cleaning, the empty line and, finally, the greater cleaning. In
order to carry out this study, only major cleanings were taken into account, which are
carried out whenever a product change is carried out, which is characterized by the change
of API, and immediately after finishing the manufacturing phase executed by the machine in
question. 

5. The SMED implementation was carried out according to the five-step methodology
developed by Shingeo Shingo with the help of a set of auxiliary tools that allow a better
implementation of this method [10]. As previously mentioned, only the adjustment phase is
classified as external work. Thus, it was necessary to optimize all other phases in order to
reduce the setup time. For that, the setup time set at 8 hours for the three compression
machines under study was established, which took into account the average times observed
for each step of the line change. Initially it was necessary to make the operators aware of the
most correct time registration in the OEE platform, in order to be able to extract all the
problems and their causes from the platform and thus be easier to solve. In order to optimize
the tasks to reach the objective setup time presented, it was necessary optimize some tasks
that are classified as internal work.

6. The improvements made had a direct impact on the phases of disassembly/assembly of

the machine and on the cleaning phase of the machine, which allowed to obtain gains of
reduction of time in each machine of about 3%. It is concluded that globally the trend of the
evolution of the times of change is decreasing, revealing success in the implementation of
SMED. 

7. The implementation of SMED as a methodology to reduce the setup time of the

compression machines under study was globally successful. The improvements
implemented were successful, allowing the overall setup time of the Kilian BB, Unipress
and Kilian D compression machines to be reduced by 11%, 4% and 1%, respectively. The

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benefits resulting from the work carried out in the Generis Manufacturing Area contributed
to annual profits of 5%. It is believed that it will be possible to achieve 11:16 9:56 10:02
9:52 11:51 11:23 February (hours) July (hours) Average Setup Times Kilian BB Kilian D
Unipress Setup (hours) Kilian BB Kilian D Unipress February 11:16 9:56 11:51 July 10:02
9:52 11:23 Gains 1:14 0:04 0:28 Gains (%) 11% 1% 4% 10 the goal (8 hours of setup time)
by the end of 2017, through continuous monitoring of work and the improvements that have
been implemented.

The legal classification of a pack of medicine determines the level of control over its
supply. In part, classification rests on how much health professional input is needed to
diagnose and treat the conditions for which the medicine might be used. Currently, there are
three categories that a medicine can be classified within:

The Classification of Medicines in Pharmaceutical industry. 

Prescription-Only Medicine (POM) - has to be prescribed by a doctor or other authorised

health professional and it has to be dispensed from a pharmacy or from another specifically
licensed place;

Pharmacy (P) - an intermediate level of control, can be bought only from pharmacies and
under a pharmacist’s supervision;

General Sales List (GSL) - may be bought from retail stores, such as a newsagent, a
supermarket or a vending machine in a shop.

The underlying principle for classifying medicines is to maximise timely access to effective
medicines while minimising the risk of harm from inappropriate use.

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