STUDENTS’ INDUSTRIAL WORK EXPERIENCE SCHEME

(SIWES) A TECHNICAL REPORT OF INDUSTRIAL WORK

EXPERIENCE AT

AGARY INDUSTRIES LIMITED

BY

NWOSU VANESSA. C

COOU/2020/204265

DEPARTMENT: BIOCHEMISTY

COURSE CODE: BCH

IN PARTIAL FULFILMENT FOR THE AWARD OF A

BACHELOR OF SCIENCE (B.Sc.) DEGREE IN BIOCHEMISTRY

DATE: NOVEMBER 2023

DECLARATION
I, NWOSU VANESSA. C, hereby declare that this SIWES report has been carried
out by me under the supervision of MR. IDUBOR ALEXANDER. It has not been
presented for an award of any degree in any institution. All sources of information
are specifically acknowledged by means of reference.

Departmental SIWES Co-ordinator

...................................
SIGN/ DATE

DEDICATION
I dedicate this work to Almighty God who saw me through, from the beginning to
the end of the industrial training scheme, to my sponsor for the financial aids and
moral support, and lastly to my loving and caring parent Mr and Mrs NWOSU for
their prayers, and encouragements.

ACKNOWLEDGEMENT
I acknowledge my industrial training supervisor, MR. IDUBOR ALEXANDER
and other departmental supervisors for all their encouragement and fatherly &
motherly love from the beginning to the end of the scheme, and I also want to
acknowledge my SIWES supervisor, for his encouragement and attention all
through this period, I say big thank you. May God bless you?

ABSTRACT
The Student Industrial training Work Experience Scheme (SIWES) was established
due to the increasing need to produce graduate from Nigeria tertiary institution
with sound practical and theoretical background of different discipline. This is a
technical report on six month industrial training carried out in Agary Industrial
Limited under the Quality Assurance and Quality Control department. This report
gives a brief insight on how the pharmaceutical industry operate and summarize
the working experience gained, knowledge learnt during my industrial training at
Agary Industrial Limited.

The Quality Assurance is an essential operation of the Pharmaceutical industry.

Drugs must be marked safe and therapeutically active formations whose
performance is consistent and predictable. The Quality Control department consist
of chemical & microbiology analytical laboratory where analysis of raw materials
before production and finished product are carried out. The requirement involving
quality control of pharmaceutical in accordance with the British pharmacopeia
(B.P) and United State Pharmacopeia (USP) and the current Good Manufacturing
Practices (cGMP) are cited and discussed. The report contains different drugs
produced in Agary, their active pharmaceutical ingredient (APIs) and method of
production. It also explains the various document required in the pharmaceutical
company, the certificate of analysis (COA) for raw material and finished product,
Batch manufacturing record (BMR), site master file (SMF), Quality manual etc.
Water and its essential in pharmaceutical industry as it Is used in production and
other works in the company. The report briefly explains water treatment and its
chemical analysis.

TABLE OF CONTENT
Cover page…………………………..……….………………………….1
Title page…..............................................................................................2
Dedication……………………………………………….........................3
Acknowledgement……………………………………………………….4
Abstract………………………………………………………………….5
Table of content………………………………………………………….6-7

CHAPTER ONE

1.1 Introduction to SIWES..….……………………………………………8

1.2 Objectives of SIWES……………………….……………………8
1.3 SIWES Regulatory Agencies…………………………….……….8-10
1.4 Benefit of SIWES………………………………….……………..10- 11

CHAPTER TWO

2.1 History of the company……………………………………..……..12

2.2 Objectives of the company………………………………………..12
2.3 Organizational chart…………………………………...................13
2.4 Products of the company………………………………………..14

CHAPTER THREE

3.1 Personal experience in the company………………………….........15

3.2 Introduction to G.M.P AND cG.M.P………………………...........15-16
3.3 ACTIVE PHARMACEUTICAL INGREDIENT/EXCIPIEN……..16-17
3.4 Quality control Department……….……………………………….17-30
3.5 Production Department……………………………………………..30-36
3.6 Quality assurance Department……………………………………..36-40
3.7 Engineering (water treatment) Department………………………….40-43
3.8 Research and Development Laboratory……………………………………..44
 CHAPTER ONE

1.1 INTRODUCTION TO SIWES

SIWES is an acronym for students’ industrial work experience scheme. It is the

accepted skills training program which forms part of the approved minimum
academic standards in the various degree program for all Nigerian universities. It is
aimed at exposing students to machines and equipment’s, professional work
methods and ways of safe guarding the work area and workers in the industries and
other organizations. It is an effort to bridge the gap existing between theory and
practice of engineering and technology, science and other professional educational
program in the Nigerian tertiary institutions.

1.2 BRIEF HISTORY OF SIWES

SIWES was established in the year 1973 to acquaint student skills of handling
industrial machinery and equipments. The Industrial Training Fund (ITF) solely
funded the scheme during its formative years. However, due to financial
constraints, the fund withdrew from the scheme in 1978. The federal Government
noting the significance of the skills training handed the management of the scheme
to the National Universities Commission (NUC) and the National Board for
Technical Education (NBTE) in 1979. In November, 1984 management and
implementation of the scheme was again reverted to the ITF with the funding to be
solely borne by the Federal Government. SIWES (Student’s Industrial Work
Experience Scheme) is a scheme for the duration of 24weeks (six months). SIWES
is done after third year first semester in universities. The effective management of
Student’s Industrial Work Experience Scheme (SIWES) has been as a result of the
cooperation and well played roles of the Federal Government, ITF, Supervising
agencies.
1.3 OBJECTIVES OF SIWES

a) Prepare students for the work situation they are likely to meet after
graduation.
b) Expose students for the work methods and techniques in handling equipment
and machinery that may not be available in the universities.
c) Provide an avenue for students in the Nigerian universities to acquire
industrial skills and experience in their course of study.
d) Enlist and strengthen employers’ involvement in the entire educational
process of preparing university graduates for employments in industry.

1.4 IMPORTANCE OF SIWES

a) The industrial program exposed me to different chemical analysis and

practices thereby putting what I was taught in school to practice.
b) It exposed me to different machineries and equipment which are not
available in school.

BRIEF HISTORY OF THE COMPANY

Agary pharmaceuticals is a company that is regulated by PCN (Pharmacy Council

of Nigeria) owned by Pharm Ubajoka Calistus. The industry was established in
1992 as a national and regional marketing company that specializes in the
importation and distribution of medical and hospital consumables. Over two
decades the company has partnered with a wide array of customers and consultants
in numerous fields and specialization. The Agary pharmaceutical company is
Nigeria’s number one company in hospital consumables. Overtime the company
also went into the manufacturing of drugs and have 2 other branches in Kano and
Onitsha as well.
 COMPANY VISION AND MISSION

 VISION
To be number one in providing healthcare products that address health and
medical needs
 MISSION
Continuously striving for improvement and innovation in the healthcare
sector
 CORE VALUES
Commitment, Teamwork, Integrity, Innovating, Knowledge, Compliance
 MEMBERSHIP OF ORGANISATION
o PCN
o PMG-MAN
o QMC-PMG-MAN
o NALP
 COMPANY’S ORGANOGRAM CHART
OGANIGRAM OF AGARY
PHARMACEUTICAL
MANAGING DIRECTOR
(Pharm. Ubayaka Callistus)

EXECUTIVE DIRECTOR
(Ubayaka Uzoma)

GENERAL MANAGER/SUPRINTENDENT PHARMACY

(Pharm. Iche Victor Mba)

OPERATIONS MANAGER
(Arazu Kenechukwu)

NSM
Warehouse head Quality Assurance
Production Manager (Pharm. David Otekpa)
(Nweke Collins) (Idubor Alexandra)
(Pharm. Nwoko Valentine)
Salesman
Production
W/H Manager Inventory Officer
Supervisor Microbiologist
(Nkechi Okpala) (Chijioke Gabriel)
In-Process (Ihioma Uchedi)
Maintenance Manager
Skilled Staffs (Ayitley Michael) Supervisor
Store Officer
Chemical Analyst
Technician Human Resource Manager (Obinna Orji)
(Jean Chukwura)

General Operations
 SOME PRODUCTS OF THE COMPANY
S/N PRODUCTS ACTIVE INGREDIENTS USES

1 Garytem – DS Lumefantrine Powder To treat malaria

Artemether Powder

2 Garylyte Glucose Anhydrous B.P For fast

replacement of lost
fluid

3 Paracetamol Paracetamol Powder For pain relief

(headache and
feverish condition)

4 Garyfol Feltic Acid Powder For pregnant

women to help
form the neural
tube

5 Hamacaplet Paracetamol Powder For pain relief

(headache and
feverish condition)

6 Hama Extra Cafleine For pain relief

(headache and
Paracetamol Powder feverish condition)

7 Garytrim Sulphamethoxozole Powder It is used as

antibiotics for
Trimethoprim Powder cough

8 Garymet Metronidazole For upsetting or

running stomach

9 Garydox Sulphadoxine Powder For developing

 Pyrimethamine Powder signs of malaria

10 Garyfen Ibuprofen Powder For body pains

11 Garyflox Coprofloxacon Powder It is used as

antibiotics for
typhoid and
infection

12 Garyfenac Diclofenac Sodium For body pain

13 Gary-B-Plex Nicotinamide, Vitamin B2, Vitamin Vitamins for the

B, body
 CHAPTER 3

PERSONAL EXPERIENCE OF THE COMPANY

My industrial training was carried in this organization for 5 months and 2 weeks. I was
trained on the various activities and processes that are followed through daily in the
pharmaceutical company. As an industrial training student, I spent most of my time in
various department in the company such as: The Quality Control department, the
Quality Assurance department, Production Unit, Research & Development department.

I was firstly taught GMP (Current Good Manufacturing Practices) which is very vital in
the running of the company and is strictly adhered to in the company. I was also given
the SOPs (Standard Operating Procedures) which are very detailed on understanding
how the various process of analysis are carried out in various department.

ACTIVE PHARMACEUTICAL INGREDIENTS

These are ingredients in pharmaceutical drugs that are biologically active components
of a drug product that are responsible for the therapeutic effects. Drug products can
contain more than one active ingredients. The dosage from a pharmaceutical, contain
the active ingredient which is the drug itself and exports which are substances of the
drug. The API is suspended in or other substances that are pharmaceutically inert.

INACTIVE PHARMACEUTICAL INGREDIENTS EXPERT

Products other than the active ingredients that is intentionally added to the dosage from
to enable processing into patients – friendly medicine to control the rate at which the
active ingredients dissolve form the dosage to aid stability and other reasons. They do
not react or affect the therapeutic action of the active ingredients.

QUALITY CONTROL DEPARTMENT

Quality control department also known as QC is a unit which inspects the quality of the
drugs. They are focused on process output. The goal of QC is to identify defects after a
product is developed and before it’s released to the market. The department has various
other department; the chemical department where all chemical analysis is done. Various
analysis are carried out in the Quality Control Department to ensure the integrity of the
products. It consists of 3 units: The chemical lab, the microbiology lab and in-process
unit

CHEMICAL DEPARTMENT

The chemical department in the QA/QC is that they design the quality standard and
parameters monitor operations and production output for quality control and help the
facility maintain compliance with regulatory and guiding bodies

Chemical Analysis Include:

RAW MATERIAL ANALYSIS

This analysis is carried out on raw materials produced by the warehouse officials for
production. Before the raw materials can be used certain analysis needs to be carried
out to ensure the raw materials are up to standard to allow for smooth manufacturing of
drugs. After the analysis is done, if the raw material passes the required parameters an
approval label is pasted on it. Only materials with approved labels are fit to be used in
the production unit. If the raw material fails, a rejected label is pasted on it which
means it is not to be used for production. Analysis majorly done includes physical tests,
solubility test, acidity or alkalinity, identification and assay etc

Example using Paracetamol

Appearance White or almost white crystalline powder

Solubility Sparingly soluble in water, freely soluble

in alcohol, very slightly soluble in
methylene chloride

Identification

First identification A, C

Second identification A, B, C, D, E
 A. Melting Point: 1680C to 1720C
B. Dissolve 0.1g in methanol R and
dilute to 100.0ml with the same
solvent. To 1.0ml of the solution
add 0.5ml of a 10.3glL solution of
hydrochloric acid R and dilute to
100.0ml with methanol R. protect
the solution from bright light and
immediately measure the
absorption maximum at 240nm.
The specific absorbance at the
maximum is 860 to 980
C. Infrared absorption
spectrophotometry
preparation comparison Disc

D. To 0.1g and 1ml of hydrochloric

acid R, heat to 600 long for 3min,
add 1ml of water R and cool in an
ice bath. No precipitate as formed.
Add 0.05ml of a 4.9 glL 50 gallon
of potassium dichromate. R.A
violet colour develops which does
not change to red
E. It gives the reaction of a cetyl.
Heat over a naked flame
Assay Dissolve 0.300g in a mixture of
10ml of water and 30ml of dilute
suphuric acid R. Boil under a
reflex condenser for 1hr, cool and
dilute to 100.0ml with water R. To
20.0ml of the solution add 40ml of
water R, 40g Ofec, 15ml of dilute
hydrochloric acid R and 0.1ml of
ferroin R. to treate with 0.1m
 cesium sulphate until a Greenwich
yellow colour is obtained. Carry
out a blank titration.

ASSAY, DISSOLUTION AND DISINTEGRATION

An assay is done to test for the potency of the Active Pharmaceutical ingredients in a
product drug. An ultraviolet spectrophotometer (UV) is usually used for this process.
To run an assay test on any product from the solid reaction. The product has to be on
granules form. The assay or potency of a drug is between 98.5% - 101.0%

Dissolution test is an in-vitro study to determine how much of the active ingredients of
the product will be made available or released into the body under a specific amount of
time. The medium is heated to 37oC which is the main body temperature. Media serves
as a buffer in an in vitro study. There are three common media used for pharmaceutical
analysis; the 0.1HCL normal buffer, Acetale buffer (buffer 4.5), phosphate buffer (6.5
buffer). Comparative dissolution is a type of dissolution test whereby there’s a
comparison of dissolution time between two company’s products with the same Active
Pharmaceutical ingredients.

Disintegration test is an in vitro study to find out the time it takes for a solid dosage
form to completely break down on the stomach.

Every drug has an active pharmaceutical ingredients (API) which must be within a
specific range in order for the drug to be effective. Assay and dissolution tests are
carried out to determine of the API meets the required range limit. For every product,
specific procedures are followed for both the assay and dissolution test.

FINISHED PRODUCT ANALYSIS

The finished product analysis is carried out for reconfirmation of a batch. When the
finished batch passes all the required test, he result is then sent to the Quality Assurance
department (Chemical Laboratory) who turns to give approval for the product to be
packaged. The batch has to pass some requirements such as weight analysis and the
assay.

S.O.P FOR ANALYSIS OF AGARY PARACETAMOL TABLETS

1. Uniformity in weight
Procedure:
2. Weight: twenty (20) tablets each, selected at random and determine
their average weight.
3. Not more than two of the individual tablets weights should deviate
from the average weight by more than ± percent

ASSAY

1. Content of paracetamol
Procedure
 Weight and powder twenty (20) tablets.
 Wight and dissolve as completely as possible a quantity of the
powder equivalent to 0.15g of paracetamol in 250ml
volumetric flask
 Add 50ml of 0.1m Sodium Hydroxide, dilute with 100ml of
water
 Shake for fifteen (15) minutes and add sufficient water to
produce 250ml
 Mix, filter and dilute 10ml of the filtrate to 100ml with water
 Add 10ml of the resulting solution to of 0.1m Sodium
Hydroxide, dilute to 10ml with water
  Measure the absorbance of the resulting solution at the
maximum at about 257nm.

Example

 Weight of sample taken = 0.1778g

 Weight of SPI taken – (0.6220 – 0.4590) g = 0.1630g
 Weight of sample II taken = (0.6530 – 0.4901)g =
0.1629g

Absorbance at 257nm

SPI = 0.425

SPI = 0.434

ASSAY IN mg/g

0.425 250 100 100 1.0 1000

SPI = 715 X 0.1630 X 10 X 10 X 100 X 1.0

ASSAY in mg/tab = 911.665 x 0.5554

= 506.338 mg/tab

0.434 250 100 100 1.0 1000

SPII = 715 X 0.1629 X 10 X 10 X 100 X 1.0

ASSAY in mg/tab = 931.542 x 0.5554

= 517.378mg/tab

WATER ANALYSIS

An important analysis done in the laboratory daily is the analysis of water.

Water is a very key part required for the production of drugs and the
condition of analysis. Water analysis is conducted to check the PH,
hardness of the water, alkalinity, acidity, conductivity and heavy metals in
the water. It is done every morning every day to confirm if the water is
safe for the day. These samples include: sampling point (Treated water).

MICROBIOLOGY LABORATORY DEPARTMENT

This is the laboratory where microbial analysis are conducted on the drug
and the environment

STERILIZATION:

It is the process of killing all micro-organisms. These are two types of

sterilization (physical & chemical sterilization). The physical sterilization
is using heating autoclave etc, while chemical sterilization is using
chemical substances such as isopropyl alcohol or any alcohol.

ENVIRONMENTAL MONITORING

Environmental monitoring evaluation is the monitoring of microbial

presence in a controlled dosed environment. After sampling of the room air
which lasts for about 1 hour to 4 hours, the samples are inoculated for 24
hours and microbial growth is observed. The outcome of the environmental
monitoring determines if the room needs immigration or not. I have carried
out this analysis.

Methods of environmental monitoring:

- Open plate: involves the use of sanitized petri-dishes with prepared

media in them to evaluate the microbes.
- Air sampling: simply they use air sampler machine to gathersome
contents in a paper strip.
Media preparation in microbiology:

There are 3 types of media based on the state

- Liquid (brot)
- Semi-olid
- Solid

 The liquid has no solidifying agent, while the semi-solid state has a
little amount (¿ 1.5 composition) of solidifying agent/agar, the solid
state is entirely made up of solidifying agent known as agar.

Based on the strength of nutrients:

 Basal media
 Enriched media

The Basal media has no additional nutrients and is used for non-specific
culturing while The Enriched media is used for culturing of gram positive
organism has additional nutrients added to it. For example; glycerol, serum
etc.

IN PROCESS UNIT DEPARTMENT

The in-process unit is the unit to run analysis on compressed tablets,

moisture of granules, disintegration, sample analysis in packaging
materials, friability on caplets: tablets, weight control check and all sub-
divisional quality control check on all lines and unit of operations. The in-
process unit controls all the processes of the individual unit of production
processes from start to finish. Quality check is done from the raw material
area, where each raw materials of different products is checked, i.e the bag,
batch no. weight, tar-weight, dirty and the mode of arrangements, this
arrangement shall follow an order of FIFO (First in first out), to be used in
the Dispensary, the temperature, humidity and cleanliness of the storage
room is also guaranteed to standard before acceptance and usage.

Quality check is done in the dispensary unit, where the materials must have
been approved from the QA/AC unit before use. Here the balance for
weighing is checked, cleared and calibrated, labels, nylons and all provided
accumately, the weighing is done at the right room conditions and at the
rights weights for dispensing the product is well stacked, before leaving for
processing (granulation). Here in granulation; approval must have been
given after the quality inspection from dispensary before processing starts.
The raw materials is mixed at the super mixer, taken to the FBD (Fluid
Bed Dryer) for drying at certain time, then taken to the miller for milling
into more smaller particles. It is then taken back into the FBD, for more
drying. Sample is taken for moisture analysis by the Qc (in-process
personnel) which after approval of bring okay (within specification) is
taken to the blender, for blending at a certain number of time. A final
moisture is also determined if it is okay for compression. All this processes
from start to finished is supervised by Q.C (in process).

WATER TREATMENT

Water treatment plant to very important in pharmaceutical industries in

order to remove imparities like colour, odour, taste and ions present and
also regulate the PH of the water to make it for production. Water
treatment can be chemical water treatment or reserve osmosis water
treatment.

CHEMICAL TREATMENT ON WATER

The source of raw water is the raw water pumped from the borehole with
the aid of a submersible pumping machine (1.5hp) into the two raw water
stainless steel tank (4,000 Litre) each through aeration shower. The raw
pumped is aerated through the shower and manually dose with calcium
hypochlorite of 65% purity and Lime into the water.

The raw water tank is then manually dosed with 200g of calcium
hypochlorite of 65% purity and 500g LIMBUS as the water is been
pumped. It is allowed to stay for a minimum of 6 hours before transferring
to the treated water holding stainless steel tank (2000 Litre). The essence
of the chlorination and lime is to disinfect the water by destroying most of
the pathogenic organism and breakdown the colloidal nature of the iron
with lime in the water

FILTRATION

After 6 hours of chlorination and sedimentation, the chlorinated water is

pumped through the treatment filtration modules with the aid of a surface
pumping machine (1.0hp) through micro filters into the two overhead
treated water storage stainless steel tanks (2000 litres). The first is the
graded sand bed, which consist of granules and fine sand for the removal
of sediments and suspended solids from the water. The second module also
houses the same materials as the first. The third module consist of the
activated carbon, which removes any objectionable odour, taste, colour,
and excess chlorine from the water.

MICRO FITRATION

At this stage, the treated water is subjected to micro filtration of filter size
5.0 and 1.0 microns before getting into the overhead treated water storage
stainless steel tanks.

DEMINERALIZATION PROCESS

From the overhead treated water storage stainless steel tanks the water
passes through micro filters of pore sizes of 1.0 and 0.5 microns before
passing through the deionizer or demineralizing plant which consist of
Cation column, Anion column, to remove the cations and anions
substances in the treated water, after which it passes through the ultraviolet
sterilizing unit to ensure thorough treatment of the water for production use
for manufacturing. The Ultraviolet sterilizing stage ensures the denature of
the DNA of any pathogen (disease causing micro-organism) after
deionizing stage. The demineralized plant is regenerated every two months
with 15% Hydrochloric Acid for the cation column and 15% Caustic Soda
otherwise known as Sodium Hydroxide for Anion column.