Emmanuel Kingsley (BTC) Production of Drugs

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A TECHNICAL REPORT ON STUDENT INDUSTRIAL WORK

EXPERIENCE SCHEME (SIWES)

UNDERTAKEN AT
DEVON PHARMACEUTICAL CO. LTD
MAGBORO, OGUN STATE

BY
EMMANUEL KINGSLEY OKWUDIRI
REGISTRATION NUMBER: 20191153115

SUBMITTED TO
THE DEPARTMENT OF BIOTECHNOLOGY
FACULTY OF BIOLOGICAL SCIENCES
FEDERAL UNIVERSITY OF TECHNOLOGY OWERRI, IMO STATE

IN PARTIAL FULFILMENT OF THE REQUIREMENT FOR THE


AWARD OF BACHELOR OF TECHNOLOGY IN BIOTECHNOLOGY

MAY 2024
DEDICATION

This report is dedicated to God almighty for his unlimited grace and consistent love. It is also
dedicated to my parents for their undiminished support throughout this whole exercise.

I
ACKNOWLEDGMENTS

Firstly, my profound gratitude goes to God Almighty for His divine assistance and knowledge
during the industrial training. My unalloyed appreciation goes to my industrial based supervisor
and other lecturers for their guidance and encouragement during the period. May the Almighty
God reward and bless you all in thousands folds. I’m indeed grateful.

II
TABLE OF CONTENT

Dedication ii

Acknowledgement iii

Table of content v

CHAPTERS 1

INTRODUCTION

1.1 Purpose of training 1

1.2 Brief history of SIWES 1

1.3 Aims and objectives of SIWES 2

1.4 Brief history of the organization 2

1.5 Aims and objectives of the organization 3

1.6 Departments in the organization and their functions 3

1.7 Organogram 6

CHAPTER 2

INDUSTRIAL EXPERIENCE

2.1 Safety precautions in the laboratory 7

2.2 Equipment in the laboratory 7

2.3 Preparation of reagents 14

2.4 Treatment of water 20

2.5 Analysis of water 21

III
2.6 Raw materials 23

2.7 Production of drugs 26

2.8 Analysis of produced drugs 36

CHAPTER 3

PROBLEMS ENCOUNTERED AND RECOMMENDATION 43


CONCLUSION 44

IV
A TECHNICAL REPORT ON STUDENT INDUSTRIAL WORK EXPERIENCE SCHEME
(SIWES)

UNDERTAKEN AT
DEVON PHARMACEUTICALS COMPANY LTD
ADDRESS: 15 OKEPAFA RD; ILUPEJU, MAGBORO 121101, OGUN STATE

BY
EMENIKE VICTOR CHIEMERIA
REGISTRATION NUMBER: 20191192585

SUBMITTED TO
THE DEPARTMENT OF MICROBIOLOGY
FACULTY OF BIOLOGICAL SCIENCES
FEDERAL UNIVERSITY OF TECHNOLOGY OWERRI, IMO STATE

IN PARTIAL FULFILMENT OF THE REQUIREMENT FOR THE AWARD OF


BACHELOR OF TECHNOLOGY IN MICROBIOLOGY

MAY 2024

V
DEDICATION

This report is dedicated to God almighty for his unlimited grace and consistent love. It is also
dedicated to my parents for their undiminished support throughout this whole exercise.

I
ACKNOWLEDGMENTS

Firstly, my profound gratitude goes to God Almighty for His divine assistance and knowledge during
the industrial training. My unalloyed appreciation goes to my industrial based supervisor and other
lecturers for their guidance and encouragement during the period. May the Almighty God reward and
bless you all in thousands folds. I’m indeed grateful.

II
TABLE OF CONTENT

Dedication ii

Acknowledgement iii

Table of content v

CHAPTERS 1

INTRODUCTION

1.1 Purpose of training 1

1.2 Brief history of SIWES 1

1.3 Aims and objectives of SIWES 2

1.4 Brief history of the organization 2

1.5 Aims and objectives of the organization 3

1.6 Departments in the organization and their functions 3

1.7 Organogram 6

CHAPTER 2

INDUSTRIAL EXPERIENCE

2.1 Safety precautions in the laboratory 7

2.2 Equipment in the laboratory 7

2.3 Preparation of reagents 14

2.4 Treatment of water 20

2.5 Analysis of water 21

III
2.6 Raw materials 23

2.7 Production of drugs 26

2.8 Analysis of produced drugs 36

CHAPTER 3

PROBLEMS ENCOUNTERED AND RECOMMENDATION 43


CONCLUSION 44

IV
CHAPTER ONE

INTRODUCTION

BRIEF HISTORY OF SIWES

Student industrial work experience scheme was established by the industrial training fund (ITF) in 1973 with

the aim of bridging the gap between the skills which the labor market required with that of those acquired by

the graduate students.

Since its introduction by the ITF in 1973, the scheme has gone through series of reform in its management,

for instance, it has changed hands from the ITF to various regulatory agencies such as National universities

commission (NUC), National commission for college of education (NCCE) and now back to the ITF again.

These are the major stakeholders in SIWES.

Consequently, SIWES programme was introduced into the curriculum of tertiary institutions in the country

as far back as 1974 with 748 students from 11 institutions of higher learning, which continues to grow over

the years.

PURPOSE OF TRAINING

The student industrial work experience scheme (SIWES) is the accepted skills training programme which

forms part of the approved minimum academic standards in various degree programmes for all Nigerian

universities. It is an effort to bridge the gap existing between theory and practice of engineering and

technology, science, agriculture, medical, management and other professional educational programmes in

Nigerian tertiary institutions. It is aimed at exposing students to machines and equipment, professional work

methods and ways of safeguarding the work area and workers in industries and other organization. The

minimum duration for the SIWES should normally be 24weeks except for engineering and technology

programmes where the minimum duration is 40weeks.the scheme is a tripartite programme, involving the

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students, the universities and the industry (employer of labor). It is founded by the federal government of

Nigeria and jointly coordinated by the industrial training fund (ITF) and the national universities commission

(NUC).

Here is their Vision and Mission Statements:

Vision: To be the foremost skills training development organization in Nigeria and one of the

best in the world.

Mission: To set and regulate standards and offer direct training intervention in industrial and

commercial skills training and development, using a corps of highly competent professional

staff, modern techniques and technology.

AIMS AND OBJECTIVES OF SIWES

Specifically, the objectives of the student industrial work experience scheme are to;

 Provide an avenue for students in the Nigerian universities to acquire industrial skills and experience in

their course of study.

 Prepare students for the work situation they are likely to meet when graduation.

 Prepare students for the work situation and techniques in handling equipment and machinery that may

not be available in the universities.

 Make the transition from the universities to the world for the work easier, and thus enhance student

contacts for later job placement.

 Provide students with an opportunity to apply their theoretical knowledge in real work situation, thereby

bridging the gap between university work and actual practice.

 Enlist and strengthen employer’s involvement in the entire educational process of preparing university

graduate for employments in industry.

2
ROLES OF STUDENTS ON THE SIWES PROGRAMME

 Attend institutions SIWES orientation programme before going on attachment.

 Register for SIWES and submit at the point of registration, their bank account details

to their school’s SIWES Coordinators.

 Comply with the rules and regulations of the organization where they are attached.

 Record all training activity and other assignments in the log book and complete ITF

form 8 to ensure proper assessment.

RELEVANCE OF SIWES TO BIOTECHNOLOGY STUDENT

The Student Industrial Work Experience Scheme (SIWES) is highly relevant to students pursuing a

Biotechnology program due to several key reasons:

 Practical Application of Biotechnology Skills: SIWES provides biotechnology students with the opportunity

to apply theoretical knowledge gained in the classroom to real-world industrial and laboratory settings. This

practical experience helps students develop essential biotechnological skills such as molecular biology

techniques, genetic engineering, bioinformatics, and bioprocessing.

 Exposure to Industry Practices: SIWES exposes biotechnology students to industry-specific practices,

standards, and technologies used in various sectors such as healthcare, agriculture, pharmaceuticals,

environmental science, and biomanufacturing. Students learn about Good Laboratory Practices (GLP), quality

control measures, safety protocols, and regulatory compliance relevant to biotechnology industries.

 Hands-On Laboratory Experience: During SIWES, students gain hands-on experience in laboratory settings,

conducting experiments, analyzing data, and troubleshooting technical challenges. They learn how to operate

sophisticated laboratory equipment, perform assays, purify biomolecules, and interpret experimental results

accurately.

 Research and Development Opportunities: Many SIWES placements offer students the chance to participate

in research and development projects, innovation initiatives, and technology transfer programs. Students

3
contribute to scientific discoveries, product development, and process optimization, enhancing their research

skills and problem-solving abilities.

 Professional Networking: SIWES provides biotechnology students with opportunities to network with industry

professionals, researchers, scientists, and experts in the field. They build professional relationships, gain

insights into career pathways, and receive mentorship and guidance from experienced professionals.

 Career Readiness and Employability: Completing a successful SIWES program enhances students'

employability by providing them with practical skills, industry experience, and a better understanding of

workplace dynamics. Employers value candidates with hands-on training and real-world exposure, making

SIWES graduates more competitive in the job market.

 Industry-Relevant Projects: SIWES placements often involve working on industry-relevant projects such as

biomolecular research, bioprocess optimization, genetic analysis, drug development, agricultural biotechnology,

and environmental monitoring. Students contribute to innovation and technological advancements in

biotechnology-related fields.

 Ethical and Regulatory Considerations: SIWES exposes students to ethical considerations, biosafety

practices, and regulatory frameworks governing biotechnological research, product development, and

commercialization. Students learn about intellectual property rights, bioethics, risk assessment, and biosafety

protocols essential in biotechnology industries.

In conclusion, SIWES is highly relevant to Biotechnology programs as it bridges the gap between

academic learning and practical skills development, exposes students to industry practices and

technologies, fosters research and innovation, builds professional networks, enhances employability,

and prepares students for successful careers in the dynamic field of biotechnology.

4
CHAPTER TWO

BREIF HISTORY OF THE ORGANIZATION

Devon pharmaceutical LTD was incorporated to do business in Nigeria as a pharmaceutical company that

deals in retail and distribution of essential drugs all over the West African region. Within a period of four

years, it witnessed a rapid growth, hence established a manufacturing outfit now calledDevon

pharmaceutical LTD .

It got approval from national agency for food and drug administration and control (NAFDAC) to produce

liquid preparations.

In 1997, it got another approval from NAFDAC to manufacture external preparations.

Devon pharmaceutical Ltd. has 49 brands of syrup and tablet that are fully registered with the appropriate

authority to sale and advertise in Nigeria.

This development has broaden the image as not only a manufacturing outfit, but the biggest pharmaceutical

producer in the northern Nigeria.

Over the years, Devon pharmaceutical industries Ltd. has built a huge financial base that runs in nine digits

The industry has earned herself community name in pharmaceutical drugs, especially essential drugs in

Nigeria through our branch network which covers all the state capital of the federation including FCT Abuja,

and Onitsha-Anambra.

THE AIMS AND OBJECTIVES OF THE ORGANIZATION

The main aim of the organization is to provide high quality essential health care products that will be

accessible and affordable to the public and to be established as a foremost pharmaceutical manufacturer in

Nigeria.

5
DEPARTMENTS IN THE ORGANIZATION AND THEIR DUTIES

Devon pharmaceutical LTD are divided into the following departments;

ADMINISTRATION DEPARTMENT

The administration department is the backbone of the organization. They serve as a link between the various

departments and ensure a smooth flow of information from one part to the other.

MARKETING DEPARTMENT

The marketing department promotes the business and drives sales of it’s product or service. It provides the

necessary research to identify your target customers.

PRODUCTION DEPARTMENT

The production department is responsible for the manufacture of high quality products that can satisfy the

need of the consumer. The production unit is guided by several rules which enables the production of pure

drug samples. The production unit is guided by several rules which enables the production of pure drug

samples. When entering the production unit, you are expected to wear your cap, mask, lab coat and factory

shoe.

QUALITY CONTROL DEPARTMENT

The major responsibility of the QC department is to ensure that all materials meet the established

criteria throughout all phases of production. Raw materials, packaging and labeling, temperature and

humidity of the production site, finished products etc. are all examined and tested according to

written program designed to assure uniformity from batch to batch. During the manufacture of all

batches of all products, in-process samples are tested and the results documented. If any result fall

outside of the written specifications, the product is rejected and in some cases reprocessed. Some

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major subunits under the quality control department include the chemistry lab, biology lab, In-process

lab and the archive.

CHEMISTRY LABORATORY: Analysis are mostly done in the chemistry lab, it is designed for

carrying out different chemical analysis on samples. The raw materials are analyzed by checking the

physical appearance, melting point, solubility etc. Water being the major raw material used for the

production is to be analyzed also by determining the total dissolved solid in it, the conductivity, pH,

total hardness and total alkalinity the produced drugs are analyzed to ascertain that it meets up to their

specifications

MICROBIOLOGY LABORATORY: It is designed to analyze the microbial load of finish

product, raw material, water and raw material, water and to do other related test, validation test,

environment’s test, swap test etc. and prevent any form of contamination that may be as a result of

self-contamination, environmental factors and poor hygiene that can lead to contamination of the

whole preparation of drugs.

IN-PROCESS LABORATORY: The main purpose is to maintain the production process of drugs

on regular basis and if necessary to adjust the process to assure that the production conforms to

specifications. Some of the test mostly performed in this laboratory are Hardness test, friability test,

leakage test and finally disintegration test.

ARCHIVE: The archive in Devon pharmaceutical LTD. is a room where sampled drugs are stored

batch by batch until they expire. The aim of storing these drugs is to monitor their stability over that

period of time in case of any controversy from the market or consumer.

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APPROVED RAW MATERIAL STORE

When raw materials from the quarantine receive a pass certificate from the QC analyst, they are transferred

to the approved raw material store and are now available for use by the production pharmacist.

REJECTED RAW MATERIAL STORE

Raw materials that did not pass the analysis carried out re being held in this area.

FINISH GOODS STORE

This is where the produced drugs are stored batch by batch until they are ready to be distributed. The

temperature in the store is monitored to assure stability and effectiveness of the product.

8
ORGANOGRAM OF DEVON PHARMACEUTICAL LTD

9
CHAPTER THREE

MY INDUSTRIAL EXPERIENCE

MAJOR SAFETY PRECAUTIONS IN THE LABORATORY

 Never pipette by mouth.

 Label everything carefully.

 Do not add water to acid.

 Dress appropriately i.e. always wear your gloves, mask and lab coat in the lab.

 Don’t taste or sniff any chemicals.

 Do not eat or drink in the lab.

EQUIPMENTS IN THE LAB

The following are the major equipment used in the chemistry lab;

 Electronic weighing balance

 Water distiller

 Water bath

 Viscosity machine

 TDS meter

 pH meter

 UV visible spectrophotometer

 Melting point apparatus

 Desiccator

 Fume cupboard

10
 British pharmacopoeia

 Glass wares

 ELECTRONIC WEIGHING BALANCE: It is used to obtain the weight of either standard

supplies, unknown samples (during identification test) or weight per ml of each drug and its batch

produced.

Weighing Balance

 WATER DISTILLER; It is a machine which is used to purify water using distillation process,

which is related to first boiling impure water after that collecting condensed water in a separate

container

Water distiller

11
 WATER BATH:

A water bath is used to heat samples at a constant temperature over a long period of time.

Water bath

 VISCOSITY MACHINE: It is during analysis to check for the thickness of drugs sample.

Viscosity machine

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 TDS meter: It is used to check the amount of dissolved solids in water sample.

TDS meter

 pH meter: It is used to obtain the acidity or alkalinity samples and manufactured drugs with

reference to its expected range.

pH METER

 UV VISIBLE SPECTROMETER: It uses visible light and ultraviolet to analyze the chemical structure

of drugs. It measures the intensity of light and the intensity is proportional to wavelength. The

13
U.V/visible light passes through the machine into the cuvette containing a certain amount of the assayed

liquid hence taking the absorbance.

Spectrometer

 MELTING POINT APPARATUS: It

is a machine that helps chemist determine the identity of the compound based on what

temperature it turns from solid to a liquid.

Melting apparatus

 DESICCATOR: It is used for preserving moisture sensitive item e.g. chlorphenamire maleate.

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Desiccator

 FUME CUPBOARD: It is a local ventilation device that is designed to limit exposure to

hazardous or toxic fumes, vapors or dusts.

Fume cupboard
 BRITISH PHARMACOPOEIA

The british pharmacopoeia is the national pharmacopoeia of the united kingdom. The british

pharmacopoeia contains a list of medicinal drugs with their effects and the directions for their use

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 GLASSWARE: Glassware are of different types and for different purpose such as; for distillation

process, separation technique, titration, solvent extraction. Examples of these glass wares include;

measuring cylinder, glass rods, conical flask, round bottom flask, test tube, pipette, glass rods etc.

Volumetric flask pipettes glass dish conical flask

TREATMENT OF WATER USED FOR PRODUCTION OF DRUGS

Treatment of water is an important factor which aids the production of drugs. The water used for

production are expected to be pure and rid of ions so as not to affect the drugs.

Reverse osmosis is a water purification process that uses a partially permeable membrane to remove

ions, unwanted molecules and larger particles from water.

The main source of water is the borehole, when the water is gotten from underground, it is first stored

in the raw material holding tank and from there it goes into the filtration process;

The sand filter: This filter is the first stage of filtration. It helps to hold back sand particles of

different sizes (smooth sand, gravel and coarse sand).

The activated carbon filter: This is the second stage of filtration. It made up of charcoal that is

treated with oxygen and its purpose is the extraction of organic compounds.

The resin filter: This is the third stage of filtration. Ion exchange occur at this stage of filtration, we

have the positive and negative resin, cations are collected at the negative resin while anions are

16
collected at the positive resin. These ions are the cause of water hardness.

Fig 1 Resins filter Activated carbon filter Sand filter

After the filtration process is completed, the water is then passed to the reverse osmosis plant

which uses pressure to pump the water and separate the dirt.

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From time to time, the treatment plant is recharged to activate its efficiency. The sand filter is

treated with ethanol, the activated carbon filter is autoclaved at a very high temperature, the

resin filter is treated with 1M HCL and 1M NaOH.

On a monthly basis, we back flush in order to remove excess dirt that has been collected by

the membrane and we use chlorine and activated salt.

ANALYSIS OF WATER

After the water treatment, the water is sampled by the quality control lab and analysis are

carried out to determine the percentage of ions that remains in the water. This test also helps

determine if the treatment machine is effective.

It is not advisable to use water containing ions for production of drugs because these ions

forms complex compounds with the drug, which may result to the production of an entirely

different substance, breaking of tablets or color change before expiry date. If the ions are

present, it must be in a specific range.

DETERMINATION OF CALCIUM ION (Ca2+)

Procedure:

 Measure 25ml of water into a conical flask (250ml)

 Add 1cm3 of 0.1M NaOH solution

 Add a pinch of murexide indicator (a purple colour is observed)

 Titrate with 0.01M EDTA VS to obtain a pink colour indicating the end point using a

suitable pipette.

18
DETERMINATION OF MAGNESIUM ION (Mg2+)

Procedure:

 Measure 25ml of water into a 250ml conical flask

 Add 1ml of ammonia buffer

 Add a pinch of erichrome black indicator (a purple colour is observed)

 Titrate with 0.1M EDTA VS until a blue colour is observed indicating the end point.

DETERMINATION OF CHLORINE ION (Cl-)

Procedure:

 Measure 50cm3 of water sample into a 250ml conical flask

 Add 3-5 drops of K2Cr2O7

 Titrate with 0.1M AgNO3 VS until there is a colour change from bright yellow to

orange brown.

DETERMINATION OF TOTAL ALKALINITY

Procedure:

 Add 50ml of water sample into a 250ml conical flask

 Add 3-5 drops of methyl orange ( colour changes to sun yellow)

 Titrate with 0.1M HCl VS (orange yellow).

19
CHAPTER FOUR

PRODUCTION OF DRUGS

At Devon pharmaceutical LTD, the drugs produced are divided into

 Tablets

 Syrup

 Suspension

My report would be limited to the TABLET SECTION, as I specifically engaged more there.

TABLETS

Tablets are solid preparations each containing a single dose of one or more active substances. They

are obtained by compressing uniform volumes of particles. Tablets are intended for oral

administration, Some are chewed, some are dissolved or dispersed in water before being administered

and some are retained in the mouth where the active ingredient are liberated.

Types of tablets manufactured in Devon pharmaceutical LTD:

 Palquine (chloroquine phosphate)

 Palmol (paracetamol)

 Palgyl (metronidazole)

 Vitamin C

 Kufcof

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STEPS INVOLVED IN DRUG PRODUCTION

WEIGHING MIXING GRANULATING

DRYING

CONSUMER

FINISH GOODS
SIEVING
STORE

PACKAGING BLENDING

BLISTERING SIEVING COMPRESSING

The raw materials to be used while producing are weighed in the electronic weighing balance, after

weighing the dry raw materials are mixed in the rapid mixer granulator for 5mins(dry mixing), then

the binder is dissolved in water and added into the mixer (wet mixing begins) for 45mins, after

mixing, the machine granulates the mixture to remove lumps. The mixture is then transferred to the

21
fluid bed dryer for 1hr, after drying. The mixture is sieved and the residue is granulated again in the

multimill granulator. The lubricant and disintegrant is blended into the mixture, in the octagonal

blender, the lubricant helps for easy punching while the disintegrant helps the tablet to disintegrate in

the body. After blending, the mixture is compressed at a particular pressure in the compressing

machine, it is then sieved to separate the compressed tablet from the uncompressed mixture. We

blister the compressed tablet, package it and transfer to the finish goods store.

PRODUCTION OF PALGYL TABLET

MATERIALS: Metronidazole, Hot water, Gelatin, Starch, T-yellow, Sodium propyl paraben,

Dibasic calcium.

PROCEDURES:

Step 1 Weigh your ingredients metronidazole, starch, sodium propyl paraben into the mixer

for 5min (slow mixing).

Step 2: add Gelatin into the mixer (first dissolve in hot water), allow to mix for 45mins

Step 3: after mixing, allow to granulate to remove lumps

Step 4: The mixture will be taken to the dryer (fluid bed dryer) for it to dry for like one hour

Step 5: Sieve and then granulate the residue in the multimill granulator machine.

Step 6: Then transfer the mixture into the octagonal blender where you add the lubricant

dibasic calcium and disintegrant to be mix for 45mins

Step 7: The mixture will be taken to the compressing machine and compressed to form

tablets

Step 8: The tablet will be sieved and then taken for blistering.

22
IN-PROCESS TEST FOR TABLETS

In-process test are test carried out during production.

Q.C performs the following in-process test during the production of tablets.

They include:

- Weight

- Friability

- Disintegration

- Hardness

- Leakage test

Weight: This is one of the in-process analysis done with the use of electronic weighing machine.

During the compression of a tablet, sampled tablets are weighed and the average taken. This analysis

helps us to determine if the compressing machine is

functioning well and if not, the pressure is expected to be

adjusted.

Electronic weighing machine

23
Friability: This test is done using a friability machine. It is done in order to test the ability of the drug

to withstand pressure as it goes from producer to consumers.

Friability machine

Disintegration: This is used to check or know the time it takes for a tablet to disintegrate in the body

of a patient. The NAFDAC standard is 15mins therefore a drug should not take more than 15mins to

dissolve in human system.

24
Disintegration Meter

Hardness: This is carried out in order to check the hardness of drug using hardness tester.

Hardness tester

Leakage test: leakage test is carried out on blistered tablet to check if the PVC is leaking. About five

pack of tablets are sampled, they are binded together to a metal rod (the metal rod helps it to sink in

the water) and displaced in water for 40mins.

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CHAPTER THREE

CHALLENGES ENCOUNTERED

During the six months SIWES program, several challenges were encountered which some of them

were overcome and include;

1 Problem of securing a place of attachment

2 Problem of not using some of the equipment

3 Problem of not able to go to other production section

4 Problem of transportation

RECOMMENDATION OR SUGGESTION

To improve the SIWES program here are some suggestion;

 The Federal government should endeavor to pay I.T allowance to students during the

program and not after in order to help the student in terms of transportation and other

personal needs.

 The company should ensure that the students are able to transfer to all departments at

various time interval to ensure that the student obtain versatile knowledge.

 The company should provide forum where student can test their experience gain before

the end of the program.

CONCLUSION

This report explains in details, the operations carried out in a Pharmaceutical industry. It gives light to

the process at which quality is maintained for every batch produced. From the knowledge and

experience obtained during this programme, I have gained new insight and more comprehensive

26
understanding of the real industrial working condition and practice with regard to polymer and textile

engineering.

27

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