Hi, i am Md. Sohanur Rahaman student of 12th batch of Pharmacy department of Khulna University, Bangladesh. Recently we have visited Zirabo plant of Incepta Pharmaceuticals Ltd., an esteemed and cGMP qualified pharmaceutical company in Bangladesh. A brief review on the visit is given here.

1. A Brief Review on Sessional Tour At Incepta Pharmaceuticals
Journey:
Our journey started at 9.00am of 21th
august, friday, from Khulna University by ‘AK Travels’ bus before
the day of company visit. We were a team of 37 students of the 12th
batch of pharmacy discipline of
Khulna University. Our team was led by two of our respected teacher, Md. Mahadhi Hasan and Dr.
Shrabanti Dev,of our discipline. We were using the ‘Aricha’ route through the ‘Vanga Mohasorak’ of
Faridpur. There was a jam in ‘Aricha Ferrighut’ that prolonging our journey time. However we reached
Dhaka at the evening of the day. We stayed the night at Dhaka.
Location:
At present Incepta has one fully operational plant at Zirabo, Savar, Dhaka (Zirabo plant) and
another at Dhamrai, Dhaka. The second site is currently under development and several projects
of finished formulation unit are being set up. The Zirabo manufacturing plant is located about 35
Km north of Dhaka City and covers an area of land about 15,000 m2
. The total built up
production area is about 300,000 square feet. At present all the products are coming from this
plant at Zirabo.
Figure-1: Savar plant of Incepta Pharmaceuticals Ltd.
Company Visit:
Our tour to company visit started the next day morning. We all reached to the incepta pharmaceuticals at
Zirabo of Savar within 9am of the morning. First we were gathered to a well furnished conferance room
of the Incepta pharmaceuticals and cordially welcomed by the authority.

2. A Brief Review on Sessional Tour At Incepta Pharmaceuticals
Figure-2: Auditorium of Incepta Pharmaceuticals at Zirabo.
At first a wonderful presentation on whole activity of Incepta was given by MD. Arshaful Islam, head of
the QC department of Incepta pharmaceuticals. After breakfast we began to visit the company by dividing
three groups. Each group was led by an honorable manager of the company. We all groups visited the QC
lab, production floor, liquid building, microbiology lab and warehouse.
QC Lab:
QC lab of Incepta pharmaceuticals has three sections for,
• Active pharmaceutical ingredients and raw materials.
• Packaging materials.
• Finished products.
Quality Control Department is equipped with highly sophisticated instruments like UPLC, Gas
Chromatography, Atomic absorption spectrophotometer, FTIR, etc. This QC lab follows STP (Standard
Test Procedure). It maintains ICH (International Conference on Harmonization of Technique) based on
GMP.

3. A Brief Review on Sessional Tour At Incepta Pharmaceuticals
Figure-3: QC Lab of Incepta Pharmaceuticals.
Dissolution Test:
Drug dissolution testing is routinely used to provide critical in vitro drug release information for both
quality control purposes, i.e., to assess batch-to-batch consistency of solid oral dosage forms such as
tablets, and drug development, i.e., to predict in vivo drug release profiles. Dissolution tester includes at
least 6 testing stations, 6 stirrers, a heating device to heat the dissolution media to a constant temperature
and a speed control usually adjustable within a range of 20 to 200rpm.
Figure-4: Dissolution tester.

4. A Brief Review on Sessional Tour At Incepta Pharmaceuticals
UPLC:
The Incepta pharmaceuticals are using today more efficient tools to develop, deliver and monitor the
drugs. In this contest the development of rapid chromatographic method is crucial for the analytical
laboratories and it would be possible by outstanding performance of ultra-high performance liquid
chromatography (UPLC), which holds back the principle of HPLC technique. UPLC shows a dramatic
enhancement in speed, resolution as well as the sensitivity of analysis by using particle size less than 2
pm and the system is operational at higher pressure, while the mobile phase could be able to run at greater
linear velocities as compared to HPLC. This technique is considered as a new focal point in field of liquid
chromatographic studies.
Figure-5: UPLC machine.
HPLC:
High-performance liquid chromatography (HPLC) is a chromatographic technique used to split a mixture
of compounds in the fields of analytical chemistry, biochemistry and industrial. The main purposes for
using HPLC are for identifying, quantifying and purifying the individual components of the mixture.
HPLC play an important and critical role in the field of pharmaceutical industries and analysis, since it is
used to test the products and to detect the raw ingredient used to make them i.e., qualitative and
quantitative analysis. Moreover, the importance of HPLC uses in these fields falls under the stringent
regulations established by the U.S. Food and Drug Administration (FDA). This obligates the Incepta
Pharmaceuticals to detect the quality of their products by using the HPLC before allowing them to sell it
in the global market. The most important benefits gain from the uses of HPLC technique in the industrial
and analytical field that it is help in structure elucidation and quantitative determination of impurities and
degradation products in bulk drug materials and pharmaceutical formulations. These benefits which gain
from the using of HPLC not only limited for the synthetic drugs and formulas but also include herbal
medicine too.

5. A Brief Review on Sessional Tour At Incepta Pharmaceuticals
Figure-6: HPLC instrument.
Fume Hood:
Incepta pharmaceuticals uses sophisticated fume hood in consideration of personnel safety in laboratory.
Laboratory fume hoods serve to control exposure to toxic, offensive or flammable vapors, gases and
aerosols. Fume hoods are the primary method of exposure control in the laboratory. The laboratory fume
hood is a type of local exhaust ventilation system (engineering control). A typical fume hood is a cabinet
with a moveable front sash (window) made out of safety glass. A properly used and properly functioning
fume hood exhausts hazardous gases, dusts, mists, and vapors from a confined location and helps protect
workers from inhalation exposure.
Figure-7: Fume hood.

6. A Brief Review on Sessional Tour At Incepta Pharmaceuticals
Atomic Absorption Spectrophometry:
The company uses this technique for both qualitative and quantitative analysis. Copper, manganese,
mercury and cadmium hallow cathode lamps were used for qualification purposes. Design qualification
such as wavelength accuracy and reproducibility, resolution and baseline stability and installation
qualification met the criteria of pharmacopeia requirements. Multivitamins and other drugs are used to
analyze by this process. For example Naproxen and ibuprofen (aryl propionic acid derivatives) both are
classified as non-steroidal anti-inflammatory agents. Except HPLC, no sensitive methods were reported
for both the drugs. HPLC methods suffer from two drawbacks- first; requirement of costly chemicals and
second; more time consuming. Because atomic absorption spectroscopy (AAS) methods are simple,
sensitive, rapid, reproducible and use low cost chemicals. The objective of present research work was to
develop highly sensitive and economical analytical methods for the quantitative estimation of naproxen
and ibuprofen in pharmaceutical formulations by AAS. The methods were based on the reaction of
naproxen and ibuprofen with copper and cobalt chloride to form colored metal complexes. These
complexes were extracted with organic solvents and digested with acids. Naproxen and ibuprofen were
indirectly estimated by AAS via the determination of the copper and cobalt content in the formed
complexes. The proposed methods may be used for routine analysis of pharmaceutical formulations
containing aryl propionic acid derivatives and similar pharmaceutical drugs.
Figure-8: AAS machine.
Gas Chromatography:
Incepta uses GC for the following purposes,
1. Gas Chromatography is used to determine the identity of natural products which contains
complex mixture of the similar compounds.

7. A Brief Review on Sessional Tour At Incepta Pharmaceuticals
2. Gas chromatography is used in separation of volatile mixture.
3. Amount of chemicals in the drugs can be identified by gas chromatography.
4. GC is used in Analysis of various solvents used in manufacturing of pharmaceutical
products.
5. GC is also used in analysis of various organic functional groups.
6. Qualitative and quantitative estimation of solid, liquid and gaseous organic compounds.
Figure-9: GC device.
FTIR:
FTIR offers quantitative and qualitative analysis for organic and inorganic samples. Fourier Transform
Infrared Spectroscopy (FTIR) identifies chemical bonds in a molecule by producing an infrared
absorption spectrum. The spectra produce a profile of the sample, a distinctive molecular fingerprint that
can be used to screen and scan samples for many different components. FTIR is an effective analytical
instrument for detecting functional groups and characterizing covalent bonding information.

8. A Brief Review on Sessional Tour At Incepta Pharmaceuticals
Figure-10: FTIR device.
ATR:
Attenuated Total Reflection (ATR) spectroscopic imaging has been employed to great effect to study the
compaction and dissolution of pharmaceutical formulations. It has many advantageous capabilities suited
for the study of pharmaceutical formulations compared to other imaging approaches, due to the high
levels of chemical and spatial specificity that can be achieved along with relatively fast acquisition times.
It is now becoming a very important tool in the development and testing of oral dosage formulations.
Figure-11: ATR device.
LC-MS/MS:

9. A Brief Review on Sessional Tour At Incepta Pharmaceuticals
Liquid chromatography tandem mass chromatography (LC–MS/MS) is an important hyphenated
technique for quantitative analysis of drugs in biological fluids. Because of high sensitivity and
selectivity, LC–MS/MS has been used for pharmacokinetic studies, metabolites identification in the
plasma and urine. This manuscript gives comprehensive analytical review, focusing on chromatographic
separation approaches as well as different acquisition modes for quantitative analysis of drugs and
stimulants. This equipment consists of three parts.
 Ionizer.
 Quadro-pole.
 Analizer.
It is a very rare and valuable machine in Bangladesh and only a few company posses it and
Incepta Pharma ceuticals is among of them.
Figure-12: LC-MS/MS device.
Auto Titrator:
In lab of the Incepta Pharma, autotitrators are used to save time and for the accuracy of titration.

10. A Brief Review on Sessional Tour At Incepta Pharmaceuticals
Figure-13: Auto titrator.
Karl Fischer Titration:
Karl Fischer titration is a classic titration method in analytical chemistry that uses coulometric or
volumetric titration to determine trace amounts of water in a sample. It was invented in 1935 by the
German chemist Karl Fischer.
Figure-14: Karl Fischer titrator

11. A Brief Review on Sessional Tour At Incepta Pharmaceuticals
QC Test for Packaging Materials:
Packaging materials are classified into three categories according to their nature. They are
primary, secondary, and tertiary. About thirteen officers are involved in testing the packaging
materials. Following tests are done for the inspection of packaging materials,
• Appearance test.
• Dimensional test.
• Physical test.
• Microbial test.
• Chemical test.
After receiving the packaging materials, the Incepta authority sampling it by a yellow color
quarantine seal. If approved the test, the lot are used as packaging materials for packing finished
products.
Microbiology Lab:
A sensitive and challenging microbiology laboratory is provided that is responsible primarily in
minimizing the numbers of microorganisms in a process environment; ensuring that the finished
product is sterile or concern with excluding those specific strains that are regarded as
objectionable from starting materials and water. Microbiology facility is replica of production
area, so as to create stimulus effect on product during testing. In microbiology facility there is
media preparation room, autoclaving room, separate storage room, infectious room and non-
infectious room. All the rooms are provided with the HVAC system with HEPA filters and with
required numbers of air changes, to maintain the separate class of area and the pressure of rooms.
Microbiology facility is dedicated for sterility, endotoxin, bioburden, cell culture and all other
microbiological testing. It contains walk in type incubator, whose temperature are controlled,
CO2 incubator for cell culture and sterility test area.

12. A Brief Review on Sessional Tour At Incepta Pharmaceuticals
Figure-15: Biosafe cabinet in microbiology lab in Incepta.
ELISA:
The enzyme-linked immunosorbent assay (ELISA) is a test that uses antibodies and color change to
identify a substance. ELISA is a popular format of "wet-lab" type analytic biochemistry assay that uses a
solid-phase enzyme immunoassay (EIA) to detect the presence of a substance, usually an antigen, in a
liquid sample or wet sample. The ELISA has been used as a diagnostic tool in medicine and plant
pathology, as well as a quality-control check in various industries. Antigens from the sample are attached
to a surface. Then, a further specific antibody is applied over the surface so it can bind to the antigen. This
antibody is linked to an enzyme, and, in the final step, a substance containing the enzyme's substrate is
added. The subsequent reaction produces a detectable signal, most commonly a color change in the
substrate.
Figure-16: ELISA test technique.
Lal Test:
In recent years, with scientific and technical advancements in the pharmaceutical and biotechnological
sectors, the demands for the quality of the products that are offered have increased. The method of
Limulus Amebocyte Lysate has come to be used for determining the absence of pyrogens in finished
products, above all, in those that are for parenteral use. The analysis of pyrogens constitutes one of the
main tests in the quality control of the production of drugs, due to its repercussions on human health.
Limulus amebocyte lysate (LAL) is an aqueous extract of blood cells (amoebocytes) from the horseshoe
crab, Limulus polyphemus. LAL reacts with bacterial endotoxin or lipopolysaccharide (LPS), which is a
membrane component of Gram negative bacteria. This reaction is the basis of the LAL test, which is then
used for the detection and quantification of bacterial endotoxins.

13. A Brief Review on Sessional Tour At Incepta Pharmaceuticals
Liquid Building:
In liquid building of Incepta Pharmaceuticals liquid and semisolid dosage forms such as nasal spray,
mouth wash etc. are manufactured. Each floor has two entry points, one for materials and another for
personnel. At first the materials are unpacked in the deboxing area since the materials are packed in a
three layer box. Then the materials are kept in the material airlock system. The area satisfies the class C
and classD level of cleanroom according to British Standard. The liquid building maintains 5S technique.
5S technique,
1. Sorting.
2. Set in order.
3. Shine.
4. Standardization.
5. Sustain.
The liquid preparations are generally filled and sealed in amber colored glass which are washed and dried
in an automatic machine. But this room is very noisy.
Figure-17: Liquid building and bottle washing process.
Production Floor:
We visited unit 6 which is used as a production floor in Incepta Pharmaceuticals. In unit six our team was
led by the plant manager Md. Maruf Hossain. This floor contains high speed tablet compressor, coating
room, tablet granulation room. Highly sophisticated HVAC systems are used to condition, monitor and
supply clean air to the working zone according to the manufacturing zone concept, capture and control
any dust, vapor, gas or fume generated, as well as treat re-circulated and/or exhausted air. Temperature
and moisture level are maintained at the desired level through this system. Here the following procedures
are completed.
Tablet Granulation Room:
It is facilitated by,
 Paste preparation vessel.

14. A Brief Review on Sessional Tour At Incepta Pharmaceuticals
 Quadro comil.
 Rapid mixture.
 Fluid bed equipment.
 Lifting and tilting device.
After granulation the granules are blended with lubricant and disintigrant, and then they are compressed
into tablets of different shapes.
Figure-18: Tablet granulation room and Equipments.
For some tablets, such as Pantonix, coating methods are used. Incepta is the brand leader of Pantonix
which is a pronounced proton pump inhibitor.
Figure-19: Tablet coating machine.
We also observed the highly automated blistering packaging of tablets which is done by the following
machine.
Figure-20: Blistering machine.

15. A Brief Review on Sessional Tour At Incepta Pharmaceuticals
This machine can automatically detect the fault of blistering.
Warehouse:
The warehouse of Incepta is an enclosed building and protects the stored goods from
environmental influences. They are secured against fire by the design of the buildings and
technical facilities. They are secured against fire by the design of the buildings and technical
facilities. The fire brigade facility has access to enable appropriate fire fighting. The locking
system of the stored goods ensures that the access to the building is controlled.
Our warehouse is equipped with four different storage conditions; a) 2o
C – 8o
C, b) 8o
C – 15o
C, c)
15o
C -25o
C, and d) ambient condition. There is specific quarantine and sampling areas with
dedicated separate storage location for cephalosporin, and steroids. Temperature sensing is
equipped with remote sensor technology.
There are controlled rooms with HVAC for specific materials and the conditions are monitored
to confirm compliance with the requirements. Also there is retention sample room. The materials
are stored in the warehouse by pallet racking. The status of materials and products is controlled
by colored status sticker. The transaction of materials is done according to "first in first out" and
“first expire first out” system. Accounting and storage is maintained through SAP, highly
sophisticated software.
Figure-21: Warehouse of incepta.
Experience and Perception:
Our tour to Incepta ended almost at the afternoon. It is a great experience in my life. Incepa is one of the
esteemed pharmaceutical companies in Bangladesh. They strictly follow the GMP rules of WHO. Incepta
is fully dependent on automated software, SAP, which is bought from Germany for five years. All the
instruments that Incepta uses are highly sophisticated and bought from renowned companies of
worldwide. Shimaduh of Japan, solac are among of them. Their HVAC system and warehouse facilities
are highly admirable. Incepata has a bunch of hard working, intelligent, experienced and highly qualified
employees. I really want to thank Incepta for giving us such opportunity and wish a good future of the
company in the pharma market.

16. A Brief Review on Sessional Tour At Incepta Pharmaceuticals