INDUSTRIAL ATTACHMENT TRAINING REPORT

SCHOOL OF PURE AND APPLIED SCIENCES

DEPARTMENT OF INDUSTRIAL CHEMISTRY

KISII UNIVERSITY, P.O BOX 408-40200, KISII, KENYA

NAME: KRENFORD SAMSON MULAMA

REGISTRATION NUMBER:PS17/00084/19

An industrial attachment training report submitted in partial fulfillment of the requirements of

the Degree of Industrial Chemistry of Kisii University

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 ©YEAR (2022)

DECLARATION
This attachment report is my original work prepared by no other than the indicated sources and

support has not been presented elsewhere for a degree or any other reward.

Signature . . . . . . . . . . . . . . . Date . . . . . . . . . . . . . . . . . . .

Name . . . . . . . . . . . . . . . . . . . . . . . . . . .. Registration number . . . . . . . . . . . . . .

SUPERVISORS

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 PREFACE

 Table of contents

 Company background

 Work experience

 Conclusions & recommendations

 References

TABLE OF CONTENTS

 Introduction to basic GMP practices

 Learning and using of sophisticated quality control instruments and equipment such as
the FT-IR, the friability tester, the hardness tester, disintegration tester, Polari meter,

dissolution tester machine, the high performance liquid chromatography, automatic

titrator, electromagnetic sieve, analytical balance and the tap density apparatus.

 Calibration of these equipment.

 Preparation of specifications, worksheets, standard testing procedures and standard

operating procedures.

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 Preparation and standardization of volumetric solutions, preparation of general

reagents and indicators

 Drug analysis

 Analysis of raw materials, packaging material, semi-finished and finished products

using analytical technique.

Company background

 The company was founded In 2004 at Syokimau Mombasa road Nairobi.

 Dinlas Pharma is a pharmaceutical company that deals in production of drugs like

ointments, cough syrups, analgesics, anti-inflammatory, antacids, co-trimaxozole

suspension, bronchodilators, emulsions and suspensions, anti-diabetic tablets,

antibiotics among others. These are just but a few of the mass production that are

produced in the EPZ facility.

 It was founded by DR.Guru Prashant and has different stakeholders one of them being

Afrique Limited.

Below is a hierarchical structure of the organization

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 CEO

COMPANY
BOARD OF PRODUCTION UNIT
HUMAN RESOURCE MANAGEMENT
DIRECTORS

SALES AND AUDIT ENGINEERING COMPANY PRODUCTION

QUALITY
PUBLIC RELATIONS STORAGE AND RESEARCH AND QUALITY CONTROL
ASSURANCE
TEAM WAREHOUSE DEVELOPMENT DEPARTMENT
DEPARTMENT

MICROBIOLOGY
LABORATORY

R&D

1.Introduction to basic GMP practices

In accordance to good manufacturing practices, there rules that are put in place to ensure

products that are being produced in the company are of good standards and minimize

contamination as much as possible. They include wearing clean protective gear (lab coat, lab

slip-ons, gloves, head cap), ensuring that the analyst is clean at all times ,jewelry of any kind is

not allowed in a production facility, the analysts hair should be clean shaven or manipulated to

manageable standards, using protective gloves and masks especially when handling corrosive

chemicals, clean fingertips and palms, correct disposition of already analyzed stability samples ,

proper conductance when in the laboratory at all times, proper use of worksheet and

specifications when conducting analysis of a stability or finished product.

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2.Learning and use of quality control equipment

In a quality control laboratory there are instruments that aid in the analysis process for proper

optimization of the production process of standard products.

Most operate on spectroscopic methods of identification in qualitative and quantitative basis.

Instrumentation is wide on its own from the ultra-violet/visible spectroscopy, Infra-red, nuclear

magnetic resonance, x-ray and mass spectroscopy.

In the pharmaceutical industry quality control department is a fundamental part of the

production process. Instruments such as the friability tester, the FT-IR, the hardness tester,

disintegration tester, Polari meter, tap density, high performance liquid chromatography and

dissolution tester are used.

Friability is the percentage weight loss of powder from tablets surface due to mechanical shock

and action when transporting from one place to another. Its carried out to check the durability

of the tablet and mass lost in powder form through chipping.

The formula used to attain specification; W1-W2/W1 × 100

Where W1 is the initial weight and W2 is the final weight. The mentioned specification should

not be more than 1%.

Disintegration time is the time required for the tablets or capsules to break into fragments

under the given set specifications. This is done at the disintegration tester.

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The FT-IR is a spectroscopic method of analysis that involves the measurement of absorption of

a narrow wavelength of radiation by molecules in a solution and running a comparison to the

standard sample. Its consists of a radiation source (nerst glower made of zirconium, yttrium and

thorium) ;a monochromatic that separates polychromatic radiation into individual

wavelengths, a detector that converts light signal into electrical signal(usually a bolometer or

thermocouple). An amplifier which converts electrical signal to % transmittance as a function of

wavenumber and recorded.

A dissolution test is an invitro test that measures the rate and extent of dissolution or release of

the active drug substance from a drug usually in an aqueous medium under the SOPs. A

dissolution tester is used to do this. The samples are then withdrawn and diluted using the

specified solvent and then absorbance read at ultraviolet spectrophotometer. Using

mathematical formulae, the specification is calculated.

High performance liquid chromatography is a spectroscopic method of analysis that entails

chromatography. It entails the separation of a component in a sample based on the fact that

the rate of an individual solute molecule through a column or a thin layer of adsorbent is

directly related to the portion of that molecule between the mobile and the stationary phase.

In the pharmaceutical industry HPLC is fundamental in determining the concentrations of

individual components in a certain drug. This is done through preparation of the mobile phase

and running through a column for some time. Successive integration using the lab solutions

software obtains the dominant peaks that are characteristic of concentration of molecules in

the drug being analyzed.

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3. Calibration of quality control instruments.

Calibration is a crucial process to ensure there is minimal to no errors when analysis is being

conducted. Using the calibration manuals, tuning is done most preferably every month to aid in

acquisition of accurate results.

4.Preparation of SOPS and worksheets.

Analysis process requires specifications when it comes to determining the amount of active

drug substance presence in a particular drug so as to ensure there is no damage when one

consumes it. Preparation and dispensation of worksheets therefore is important to an analyst.

Using the British Pharmacopoeia, worksheets are formulated as they are within the standards

of health merits.

5.Preparation and standardization of volumetric solutions, general

reagents and indicators.

In the analysis process, solutions of desired concentrations can be prepared to dissolve the

active ingredient in the drug, for instance in ibuprofen the active ingredient is paracetamol. To

ensure it completely dissolves and to determine its concentration a volumetric solution of 1M

sodium hydroxide is required.

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A quality analyst also has to be well versed with preparation of solutions that involve dilution of

concentrated acids that are used in the titration process. Indicators are important in

determining the endpoint of a reaction.

6.Drug analysis

From analgesics to antibiotics, drug analysis is important to quantitatively and qualitatively

determine the concentration. Piroxicam a non-steroidal anti-inflammatory drug mainly used for

treatment of rheumatism, relieve painful symptoms and arthritis early painful post-operative

pain by preventing the production of certain types of chemicals is analyzed using the FT-IR. It

shows a characteristic vibrational peak for –OH and –CH3 stretching at 3526 cm-1 and 3162 cm-1.

Vibration peaks at 1654 and 1610 cm-1 are assigned to C=O and C=C stretching respectively. The

N-H amide bonding appears at 1565cm-1.

Asymmetrical bending in C-H bond appears at 1507cm-1 and C-C stretching peaks at 1443-

1437cm-1.

Indomethacin is a non-steroidal analgesic and anti-inflammatory. It treats active stages of

rheumatoid arthritis, osteoarthritis, degenerative joint disease of the hip, acute musculoskeletal

disorders, inflammation and oedema.

Analysis is carried out for the active ingredient indomethacin with tests such as specific gravity,

uniformity of dosage, dissolution, assays and disintegration time.

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Specific gravity is a test carried out to determine the amount of the active ingredient in a

particular drug and entails use of certain steps using an analytical balance.

Uniformity of dosage entails the weighing of a specified weight amount, dissolving with a

specified a reagent and reading the absorbance at the U.V and applying mathematical formulae

to attain required specifications.

Antacids (neutricid tablets) are bases that react stoichiometrically with acid. The number of

moles of acid that can be neutralized by a sample tablet of a commercial antacid is determined

by back titration. The antacid is dissolved in a known excess amount of acid. The resulting

solution acidic as the tablet does not provide enough moles of base to neutralize the acid.

The solution is titrated with base of known concentration to determine the amount of acid not

neutralized by the tablet. To find the number of moles of acid neutralized by the tablet, the

number of moles of acid neutralized in the titration is subtracted from the moles of the acid in

the initial solution.

7.Analysis of raw materials, packaging of material, semi-finished, and

finished products using analytical technique.

For any production process to begin there has to be raw materials. Some materials are placed

in stability chambers to ensure they don’t go bad. In the pharmaceutical industry, the stability

block is responsible to know the shelf life to these materials. Most times a small sample batch is

first produced and analysed to determine the composition of molecules and if the product is

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suitable for mass production. Once this is certified, then mass production is done through a

series of process validation steps.

Use of analytical technique and instruments comes in handy in these processes. Packaging

material is also analysed to ensure minimal shock in the transportation of the finished product.

SUMMARY OF TASKS

At the facility I was mainly situated at the quality control department where drug analysis from

the physicals to the tactical side. Some of the tasks included water analysis of water at the

facility that was used in the production process. Drug analysis of the semi-finished and finished

products using analytical technique and analytical instruments such as the friability tester, ultra

violet spectrophotometer, high performance liquid chromatography among others.

Conducted physical tests such as specific gravity, uniformity of weight, uniformity of dosage,

neutralizing capacity, assays on drugs like paracetamol, neutricid tablets, piroxicam, gripe

water, glucostat tablets, azithromycin tablets, co-trimaxozole suspension, ointments and

cozfit(a cough syrup).

Calibration of the analytical instruments which was done monthly except for the analytical

balance which was calibrated daily using complex statistics.

Dispensing and creation of worksheets using the British pharmacopoeia which is in accordance

with the standard health merits.

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 WORK EXPERIENCE

1. Projects done

Some of the projects done include establishing shelf life of raw materials used in production

process. Conducting analysis using HPLC which required preparation of mobile phases.

2. Supervisory work

Given that the HPLC is a complex instrument, most of the teaching was done through

supervisors. The quality analysts were very crucial in the operation of the sophisticated

instrument. From the preparation of the mobile phases to running and comprehending

the lab solutions software, I can attest that they were very helpful.

Conducting analysis of various drugs at times needed inquiry from the analysts.

3. Problems faced and solutions

Some of the challenges encountered not being able to complete analysis of a finished

product that was supposed to be dispatched for selling. This at times occurred at the

dissolution tester as only two batches can be run at a time in the event that 5 batches

required analysis. This was time consuming and wastage of resources. I would

recommend purchase of another dissolution tester to solve this.

The HPLC at times could breakdown and the maintenance would take some time.

Analysis is not conducted as per scheduled.

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The training programme was all inclusive as I acquired essential analytical skills. I look

forward to applying this in my field of expertise and pioneer the bravado of science. Its

very interesting if you ask me.

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