AUTOMATION OF WORKING PROCEDURES IN QUALITY

AND PRODUCTION DEPARTMENT OF PHARMACEUTICAL

INDUSTRY

Manal Khan Niazi and Ajay Kumar

Prof. Dr. Ather Akhlaq

Supervisor

A THESIS SUBMITTED IN PARTIAL FULFILLMENT OF THE

REQUIREMENTS FOR THE DEGREE OF MASTER IN BUSINESS
ADMINISTRATION IN HEALTH MANAGEMENT
DEPARTMENT OF HEALTH & H
OSPITAL MANAGEMENT
INSTITIUTE OF BUSINESS MANAGEMENT
KARACHI-PAKISTAN
07, 2020
 Chapter 1

INTRODUCTION

1.1 Background

Pharmaceutical makers are accomplishing huge advantages utilizing computerized

frameworks. Some have communicated plans to actualize a 'paperless domain' to make an

upper hand. Present FDA exercises have all the earmarks of being moving towards

electronic recognizable proof as equal substitutes to manual ID making mechanization a

feasible administrative reality. Producers are utilizing process mechanization, computer

integrated management system, e-work commands and hierarchical change the board as

components of operational procedures to help these new corporate objectives and targets.

Business re-designing, authoritative arrangements and business process investigation

are being utilized to make the data stream characterizing the smoothed out worth

included errands. Applications like procedure automation, information assortment

frameworks, programming items like QMS, SAP MRP run, product MRP and electronic

recognizable proof will give the information what's more, exchanges for this data stream.

Every application gives benefits inside its own practical condition. Nonetheless, these

advantages are amplified through the data coordination of the individual applications.

[ CITATION MAH \l 1033 ]

1.2 Research Objectives

 To find out effects of automation in a pharmaceutical industry

 To find out whether employees of the industry will easily adopt the automation of

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 the work or will face difficulty to move from manual work

 To find out whether the quality will be affected after implementation of robotics

1.3 Problem Statement:

To study the effect of automation in pharmaceutical industry

1.4 Purpose of the study

The purpose of the study is to find out about awareness of robotics in pharmaceutical

industry and to implement robotic inspections especially in local industries so that people

could sort out their rejections 100%.

LITERATURE REVIEW

In a situation where financials, practicality, and quality run the organization, this is

fundamental to search for responses in innovation where these difficulties must be seen.

In a well-known pharmaceutical Quality affirmation site, automation and mechanical

autonomy have Become only the apparatuses to address these difficulties. In spite of the

fact that automation is a generally new idea in our specialization, we have completely

grasped it inside only a couple of years. As our organization experienced a mix, there was

a significant decrease staff in site where the quality confirmation division through

intentional and automatic partitions. Anyway the outstanding task at hand stayed steady

or in A few cases really expanded. So even with decrease in research center Work force,

they improve profitability while keeping up trustworthiness in Quality testing.

Benchmark examines showed the site to be the decision fabricating site above different

offices. This is credited to the site office workers' promise to decrease process duration,

improve efficiency, and keep up significant level of administrative consistence. One of

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the more grounded contributing components was computerization Innovation in the

laboratories, and this innovation will Keep on helping the site's status later on. The

automation gathering was initially shaped around two years prior to meet the requests of

excellent confirmation testing throughput needs and to bring our testing bunch up to

norm with the business. Computerization started with just two individuals in the

gathering and now We have three individuals who are the cutting edge mechanization

researchers. Indeed, even with such a little stage, we have made incredible steps in

research center mechanization as we have worked broadly with each bit of gear acquired.

Nonetheless, with the association from the clients at 'get– Go', we had the option to

effectively get numerous computerization advancements. The fate of item testing lies in

computerization, and we will keep on investigating the conceivable outcomes of

improving the testing Strategies so the scientific experts will be less troubled with routine

and unremarkable day by day assignments and be more centered around bringing Quality

into our items.

The merger and in this manner the formation of company brought about difficulties that

must be tended to very quickly. These difficulties included lessening the Workforce,

reducing expenses, expanding efficiency, moving items from different locales, and

benchmarking the site as the head producing site. As these difficulties surfaced, the

quality affirmation division (working under specialized activities) reacted rapidly. One of

the reactions was the development of a computerization care group to acquire

frameworks that would build proficiency and efficiency and hence definitely cut

expenses for the research center tasks.

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Taking a gander at the benefits of the multiple dose computerized disintegration

framework, one can without much of a stretch perceive how the flexibility in addition the

efficiency of the framework gives significant additions in testing items. A portion of the

detectable favorable circumstances of the framework include: fast and precise vessel

filling with chose media, exact environmental temperature examination, unit and

multipoint disintegration, efficient and fast container washing, up to eight groups for each

arrangement, and Interfacing ability to chemical testing methods or a division Gatherer.

Likewise, the robotized frameworks bring cost reserve funds that can be quantitatively

estimated.

As recently investigation of data frameworks chiefs demonstrated that various past usage

in computer integrated management system (CIM) had not accomplished their proposed

business objectives. Absence of financing what's more, the executives support seems, by

all accounts, to be the utmost exciting restrictions to executing cim. Per the study, better

mix of assembling data was a significant improvement region [ CITATION Spa94 \l 1033 ]

An overview on commercial hindrances to cim reasoned that framework arrangements

must address more than data innovation. A staggering 70% expressed that individuals,

just as preparing, associations, and changes in culture should be remembered for any

fundamental arrangement. All organizations are diverse in business headings, producing

styles and social points of view. So as to attempt cim programs, the executives will keep

on settling on choices based upon the investigation of a program's return for money

invested or budgetary commitment to the main concern [ CITATION MPo15 \l 1033 ]

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Examinations like net present worth utilize present day suppositions. Different strategies

are more creative by not accepting that current industry what's more, organization

conditions will stay steady during the existence pattern of the program or by

characterizing key non-quantitative advantages just as customary monetary measures.

These strategies endeavor to invalidate the moderate bookkeeping maxim that appoints

zero an incentive to vital advantages of cim in order to be completely off-base to being

mysteriously right [ CITATION DHS91 \l 1033 ]

Potential advantages can be found in data sharing through utilitarian mix by methodical

methods and enabled laborers in every aspect of manufacturing which includes many

systems i.e., planning and execution of manufacturing resources, quality management

processes, quality control, CAPA and change control management, calibration and

maintenance of equipment in manufacturing facility, in process checks and process

controls etc [ CITATION JWi91 \l 1033 ], [ CITATION JWi94 \l 1033 ]

All regions where the future state is not the same as the current condition speak to

possible wellsprings of advantages as expanded profitability, more noteworthy

efficiencies, justification of roundabout errands, better usage of heritage process control

frameworks and cost shirking. These advantages should be evaluated without trading off

administrative consistence and assembling control to be valuable [ CITATION Mes93 \l 1033

Total quality management (TQM) way toward improving the board of a whole

association with the goal that it exceeds expectations in all perspectives of items and

administrations; it has accomplished more consideration in latera long time in the human

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services industry. It is fundamentally a dedication to consistent, enhancement in

qualification from all aspects, to the most significant level administration to the lowest

employee level, from the crude materials provider through the gracefully chain to the end

shopper. In a profoundly computerized information catch condition, such thoughtfulness

regarding quality has become a precondition for greatness; these realities will be shown

in the two contextual investigations of cardiovascular checking frameworks. Quality

affirmation in the social insurance field and the responsibility required are essential all

together effectively contend in the worldwide commercial center as a world-class

association. As indicated by 02 members in (2006), the seven segments of TQM

incorporate nonstop improvement, six-sigma, worker strengthening, benchmarking,

without a moment to spare (JIT) stock, taguchi ideas, what's more, TQM apparatuses.

Ceaseless development and six-sigma are utilized to improve existing items and lessen

surrenders throughout creation, to bring down expenses and spare time. Worker

strengthening joins the workers in ordinary administration and dynamic, improving

response time and execution, and bringing about more joyful workers. JIT stock

administration is another case of nonstop improvement, for example, decreased physical

stock in a distribution center methods spared costs in diminished overhead, mistakes and

imperfections can be immediately recognized and fixed. Taguchi ideas bring about hearty

items and target-arranged quality [ CITATION DSm08 \l 1033 ]

While TQM and automatic identification and data capture (AIDC) accomplishments

increase company and service of product, application of TQM is not easy, since it usually

involves changes in culture of organization. The situation is not essentially factual for

AIDC-related techniques since the variations operational and management can see cost

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reduction in a short span. However, TQM application needs changes in entire system to

gain enhance business performance and employee behavior could be change [ CITATION

Ehi06 \l 1033 ]

TQM needs a solid assurance from top Management, who should monitor the entire

system in every aspect, which need to be change with a new organizational demands

[ CITATION Str07 \l 1033 ]

Numerous TQM components are individuals situated and incorporate practices Such as

collaboration and worker strengthening. A few Researchers have demonstrated that

specific character traits from Management and workers are basic for TQM consistence.

TQM needs Individuals who are exceptionally friendly, to exhibit worry for customers

and constantly improve consumer loyalty; components That are basic in advertising

wellbeing administrations. Since numerous administrators May experience issues

surrendering their places of power, to permit Employees more noteworthy cooperation in

the dynamic procedures; TQM usage in these cases work may flop because of absence of

Management support. A responsibility must be additionally made to The consistent

improvement of the item. Careful testing and examination must be made to diminish

deformities to the point of Zero imperfections through the procedure of constant

improvement. Complete and exhaustive records must be kept and workers or

Management the same that don't have the assurance may cause a Failure of TQM usage

[ CITATION Sil07 \l 1033 ]

An expanding realization of the prerequisite to support Quality Management System

(QMS) activities to a great extent on account of expanding quality-based rivalry.

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However, while QMS activities are today seen more comprehensively and genuinely than

they were already, there still is by all accounts a shortage of cognizant frameworks and

methods to help quality confirmation. There is no occurrence that nobody ever present,

pc based assembling control frameworks has a coordinated module committed to quality

affirmation.

Absence of sufficient data frameworks saw to be common inside and out the

organizations with quality issues, and the measure of declaring point of interest

corresponded intimately with contrasts in quality execution. The point of this paper is to

plan a fundamental system for remembering the quality measurement industrial facility

computerization data of a common discrete-parts maker. It's notable that a dominant part

of firms goes under the classification of cluster fabricate. While developing the

framework of QMS in organization system, we should consider the changing examples in

quality administration and furthermore the advancements in adaptable computerization

going down during this specific circumstance [ CITATION Alf13 \l 1033 ]

The effect of value due to computer system coordinated assembling is by all accounts

critical, both by method of requiring changes in interior control methodology and

furthermore through the consequence of higher and more reliable quality. What's more,

changes to existing interior control methodology in 72%. In a primer overview on

manufacturing plant automation in 67 US organizations, upgrades in quality happened in

65% of the organizations. However, upgraded item quality neglected to figure as a key

thought inside the presentation of manufacturing plant mechanization in any of those

organizations, in spite of the fact that it's broadly realized that predictable item quality is

one among the significant advantages of computerization [CITATION Eli07 \l 1033 ]

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 Chapter 3

RESEARCH DESIGN & METHODOLOGY

3.1 Design of the study

The design of the data is based on qualitative analysis, i.e. interview based

approach. It covers detailed explanation of investigation. The technique was selected so

that we can analyze the quality of work [ CITATION Onw12 \l 1033 ]. Qualitative data

provide strength to the research.

3.2 Study setting

The study was conducted in different pharmaceutical industry of Karachi, Pakistan.

Pharmaceutical industries have a big power in business world of Karachi, Pakistan.

[ CITATION Gha12 \l 1033 ]

3.3 Target population

People who are working in quality assurance and production department of

Pharmaceutical industries in Karachi, Pakistan. The population targeted from both

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multinational and local pharmaceutical to eliminate the factor of biasness and to approach

our results from every setting.

3.4 Sample size

12 people and industries were selected for sample size but some of the respondents

had denied to share their views as it was against organization’s policies. The sample

contains both middle level management and higher level management.

3.5 Instrument / measure design

The instrument was designed in the format of interview based questionnaire.

Following questions were asked:

a) How your organization deals with the processes? Are they automated or

manual?

b) What do you think how will your employees will react towards the changes

implemented?

c) Do you think if automation will be implemented, what will be the risk – benefit

analysis?

d) In your opinion how can be the automation is better than manual work?

3.6 Duration of the study

The time period of the research was from June 2020 to august 2020

3.7 Method of data collection

The interview was taken by face to face conversation and also on phone calls. No

third person was included in taking interviews to maintain accuracy of results

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 Chapter 4

DATA ANALYSIS & RESULTS

The results are identified in this chapter along with its interpretations and findings

in relevance to the hypotheses tested.

4.1 Demographics Profile

There are 8 respondents who were willingly agreed for their interview out of 12

respondents we selected in which there are 5 females and 3 males candidate. We had

approached Quality Assurrance and Production Department of Pharmaceutical industries

to review how the deal with their processes. The individual;s who had willingly gave

their interviews are composed of Quality Assurrance Officer (n=2), Sr. Quality

Assurrance Officer (n=2) Quality Assurrance Manager (n=1), Production Officer (n=2)

and production Manager (1). Participants those had denied for giving interview are both

QA and Production Officer combinely (n=4)

Participant’s demographics are listed below:

Table 1: Demographics of participants

CHARCTERISTICS NUMBERS
GENDER
MALE 3
FEMALE 5
DESIGNATION
SR. QUALITY ASSURRANCE
2
OFFICER
QUALITY ASSURRANCE OFFICER 2
QUALITY MANAGER 1
PRODUCTION OFFICER 2
PRODUCTION MANAGER 1

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4.2 Analytical Results

We had conducted total 4 questions as are selected participants do not responds much

questions for detailed answers. The statements are given below

i. Question no 1: How your organization deals with the processes? Are they

automated or manual?

a. we are dealing with the manual processes. For example we do our in

process by checking the volume of liquid of syrups, solutions and drops by

volumetric cylinder, for injection we check volume by syringe. For tablets

we check the following parameters: weigh tablets in weighing balance,

test of disintegration to check the disintegration time, we do friability test,

dissolution test, hardness test and we check the diameter and thickness by

vernier caliper

b. we deal with automatic and semi automatic machines. These both are very

efficient in their working

c. As our organization is newly developed company so initially we are dealing with

mostly manual processes. but further we are looking forward for automation

d. we deal with semi automated processes. Like manually we check weight of our

dispensed product. We do not have such machines that could be use for our

trial batches so we perform many processes manually like seiving and drying of

granules

e. we deal with automated processes. We have checkwares on each and every

point so that there wil be no chances of error at any stage.

ii. Question no 2: What do you think how will your employees will react towards

the changes implemented?

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 a. We would face very difficulty as our most of the employees are working here in

manual system. if we suddenly provide them with automatic machines their

reaction would not acceptable

b. Start with leadership, Everyone maksure that change is postive and benefit

them personally

c. They will not be happy since they can feel insecure towards the change

d. our employess will definitely get happy if we could made changes to ease their

work and probably they will work more hard

e. our employess would show positive attitude toward changes as we are

providing them trainings for the new changes, their knowledge will be increased

iii. Question no 3. Do you think if automation will be implemented, what will be

the risk - benefit analysis?
a. Whether it is automated or manual system there must be some pros and cons

of it. on one hand it can decrease human error, so on the other hand human

negligence can be occurred. on one hand labour work is reduced so on the other

hand your employees would have no work to do.

b. Better technology and IT facility with good back up required as well as

individuals needs to be trained properly and assessed

c. More efficent production, Higher labour productivity, Cheaper goods increases,

Can remove risk of human error, Consumer satisfaction

d. if we move to automation from semi automation the risks would be much lesser

than the benefits. Because we can give much more production which could

increase our demand in market

e. benefit is that we get more advance technology and trainings which can

increase our knowledge and risk is that the importance of original signed

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 document would not be considered and employees show carelessness towards

that original signed document

iv. Question no 4: In your opinion how can be the automation is better than manual
work?
a. automation is much better that manual work so there shall be less paper work.

every thing you want can be easily accessible in a minute. you would not have to

search thing which can be obviously very time consuming

b. It provides error free data. Maintains data integrity, Time saving

c. Automation can actually deliver better results because of its ability for increased

coverage.

d. automated work can decrease human error. It can ease your work. It is less time

consuming. Risks can be eliminated and also identified during production

e. as I told before that it will be less time consuming. Moreover we can give more

production so company will prosper. If in future we face any problem regarding

market complains, so we can easily access the stage through our automated

systems

Chapter 5

DISCUSSION AND CONCLUSION

Discussions based on your findings in context with the past research findings.

Some recommendations and implications are also mentioned with the future research

Possibilities to the research conducted. This chapter may include the following:

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5.1 Discussions

The results of the study has shown that local pharmaceuticals are dealing with

manual processes mostly but as we move forward to the higher level of organization i.e.

from local to multinational the systems and processes also move towards manual to

semi-automatic or only automatic systems.

The study has revealed that if changes were implemented in multinational

pharmaceuticals their employees shows positive attitude towards the changes. They

would be happy to work on modern technology whereas, in local pharmaceuticals if

changes implemented then the behavior of the employees would not expected as positive,

their employees would feel insecure towards the changes as they are not well trained

Respondents from every pharmaceutical had told us that risks of automation could

be carelessness attitude, they would neglect importance of original signed documents as

they everything is secure in their systems. Whereas, benefits of automation could be less

time consuming, elimination of human error, backup can be easily accessible, time

management could be handled properly, market value and demand would increase,

coverage would increase, cost would decrease, market complaints and obligations could

be eliminated, risks could be managed or eliminated.

5.2 Conclusions

The study has concluded that for the dealing of procedures in quality and

production department, automation is much better than manual work. It has been proven

by interviewing our respondents who were consist of both middle level management and

higher level management of pharmaceutical industries of Karachi. But there are also

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pharmaceuticals whose employees would not be happy if their procedures move towards

automation as they would feel insecure there. In that case its organization’s responsibility

to train their employees with the new technology before implementation so that the

environment would remain healthy with the changes.

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