Quality Control System of Beximco Pharmaceuticals Limited

Executive Summary:
To assure the quality of the products we have to use different types of measurements or
numerical mathematics. Sometimes ensuring quality of the products by numerical mathematics is
impossible because this process takes lengthy time there has much more possibility to make
mistake. That is why we use some statically method, which is called control charts.
When the quality controls have to focus on a quality characteristic hard or expensive to measure
on a numerical scale, the control chart for attributes are a useful alternative.
Attributes concern quality characteristics which are able to be classified in two types, conform
and not conform to specifications. What is called nonconforming means that the unit controlled is
not conformed to standard on one or more of examined quality characteristics.
The goal of control charts for variable is still to control mean and variability of a process but here,
we focus of number of nonconforming units or nonconformities in a population. Three types of
charts exist. Their use depends on the production (which quality characteristic to control, how

many to examine), the characteristic of controls (constant or variable sample size):

The p-chart: it is a control chart for fraction nonconforming
The c-chart: it is a control chart for number of defects or nonconformities
The u-chart: it is a control chart for number of nonconformities per unit
INTRODUCTION
Subject like Pharmacy demands practical knowledge in the own field. Thus industrial training
program is one of the most important parts of a students studying in a dynamic subject like
Pharmacy. For gathering complete knowledge about pharmacy there is no alternative for In-plant
or industrial training program which has to be accomplished by every student of pharmacy after
his/her final year (B.Pharm.) examination. This training is conducted by the pharmaceutical
industries in our country. By this training, each pharmacy student can achieve vast experience;
can correlate the theoretical knowledge with the practical experience. Thus he/she can develop
him/herself completely for pharmacy related job. To take part in such type of training program I
have been selected for The Beximco Pharmaceuticals Ltd.
The Beximco Pharmaceuticals Ltd. is the leading pharmaceutical company of Bangladesh. This
company manufactures product not only for the market of Bangladesh but also for the
international market because they manufacture products having higher quality. They maintain
cGMA in the production area and also they have well developed SOP. Besides they do IPC
properly that is very important thing for manufacturing quality products.
Beximco Pharmaceuticals manufactures a range of dosage forms including tablets, capsules, dry
syrup, powder, cream, ointment, suppositories, large volume intravenous fluids, metered dose
inhalers etc. in several world-class manufacturing plants, ensuring high quality standards

Quality Control System of Beximco Pharmaceuticals Limited

complying with the World Health Organization (WHO) approved current Good Manufacturing
Practices (cGMP).
My training program was from 18th July to 2nd August,2010. During this period I have visited &
worked in every section under the direct supervision of related officers.
HUMAN RESOURCE DEPARTMENT
The Human Resource Department of the Beximco Pharmaceuticals ltd. does different kinds of
jobs for the frequent running of the industry. Among all these some of the important jobs that are
done by the department are discussed below:

Recruitment of personnel: one of the most important jobs of the HR department is to appoint

personnel having appropriate qualification as well as experience to fill the position that have an
effect upon the quality. In so doing, different kinds of standards are considered for different
positions.
Prepare monthly manpower statement: The HR department has to prepare the monthly

manpower statement of the plant by the 5 th of every month. It includes DL to the Director. To add to
this, it also prepares the daily manpower statement.
To maintain and update personal files: One of the outstanding jobs the HR department is to

maintain and update personal files of all employees of the industry. Confirmations of jobs,
promotion, transfer etc. are included in this file.
Informing policies: The HR department generally informs the managers and employees

regarding personal policies and procedures of the company.

Coordination of performance appraisal: This department coordinates and monitors

performance appraisals of plant employees. The process of evaluating of performances is

happened in many methods.
Asses training: The HR department generally asses the training needs of personnel in light

with cGMP (current goods manufacturing practice) and others related HRD issues. The training
also includes- GMP, Safety, and Laboratory standard and workplace environment in the
pharmaceutical industry.
To arrange induction training programme: To arrange the orientation program that is

arranging induction training program for the new employees of the industry is the job of the HR
department. As soon as each employee joins, she or he is introduced with the entire department
and he is also taught the functions about the operations of the company.
Preparing and arranging in plant program: The HR department prepares and arranges the

in plant training programs for the students of different universities. This is an extra typed job of the
department and to do this all kind of coordination is done by the department itself.
Dealing with industrial related issues: Generally the industrial related issues such as

negotiation with employees union, ensuring the labor rights etc are done by this department.
Ensuring proper implementation of Labor Law: This department one of the main jobs is to

ensure the proper and exact implementation of the Labor Law that is applicable to the factory
workers and the employees.
Taking Disciplinary action: This department has the right to take any kind of disciplinary
action including punishment, suspensions and termination from the job.

Quality Control System of Beximco Pharmaceuticals Limited

Maintaining liaison with Government Regulatory bodies: HRD keeps relation with the

1.
2.
3.
4.
5.
6.
7.
8.
9.
10.

following Government regulatory bodies for the legal aid. Or helps in any accident or medical aid:
Ministry of Health, PeoplesRepublic of Bangladesh
Office of Directors of Labor
Explosive departments
Director of fire and the fire station of Tongi
Toni thana, NSI, DB and SB
The Pourosova of Tongi
Customs and Vat, Tongi circle
Office of the Deputy Commissioner, Gazipur
Office of the Superintendent of Police, gazipur
Civil Surgeon, gazipur.
Supervise official works: To supervise and monitor the attendance of the employees, job

cards regularly and prepare monthly summary and daily absent reports etc are the jobs of the
HRD.
To monitor leaves: The HRD monitors leaves of plant employees. Each employee has a leave

1.
2.
3.
4.
5.
6.

file that integrate all kinds of leaves likeAnnual leave

Medical leave
Casual leave
Special leave
Maternity leave
Leave without pay etc.
Ensuring safety: To ensure the safety of all employees and company assets as well as

ensuring proper security management of the plant are the jobs of the HR department.
Handling visitors: The work of handling external visitors and arranging all necessary uniforms

and other accessories is done by the HRD.

Supervising: The HR has to do several supervising jobs as follows:

1.
2.
3.

To supervise transport tools (distribution, repair and maintenance)

To supervise canteen management.
Supervise of all cleaning services of the plant (House keeping and gardening etc.)

SAFETY
DEPARTMENT
Aim of this department is to create awareness to the working personnel of the factory through
training, SOPs, and carrying out inspection or audit to observe the implementation of training and

Sops. Activities of safety department are as followsInduction of training for safety

Collection of Material Safety Data Sheet (MSDS)
Taking preventive action for fire
Identification of hazardous area and taking preventive measures
Preparation of SOPs for handling chemicals

Quality Control System of Beximco Pharmaceuticals Limited

Identification of criticalities of machineries and providing awareness & safety

Providing Personnel protective Equipment (PPE)
Providing First Aid & its using procedure
Arranging yearly Medical Check up program
Identification of pipelines by using different colors on them according to the standards
Identification of dangerous goods by using different symbols on them according to the
standards
Providing Automatic Fire Alarming System with smoke & heat detector
Providing training for using alternative exit way in case of any type of emergencies.

TRAINING
DEPARTMENT
One of the agenda of the Human Resources Department is continuous development of the
employees so that they can cope with the rapidly changing business environment. Innovation is a
major priority that they want to promote. Accordingly, training programs are regularly undertaken
for the staff to seek opportunities for skills improvement.
Employees of BPL are participated in various training programs both external & internal. There
are six induction training for the field force, four in-house training & two external training for
employees of the Head Office during this period. Factory personnel also attended in-house
training programs of total 206 hours duration.
Training Procedure:
Training needs analysis
Select resource person
Prepare training calendar
Conducting training session
Evaluation of training, trainee
Documentation
Retraining
Training type:
Classroom training
Audio-visual training
Interactive training
On the job training
Group exercise
Training applies to:
All persons engaged in manufacturing directly and indirectly.
Manager

Quality Control System of Beximco Pharmaceuticals Limited

Officer
Workman
Covered area:
Solid manufacturing plant
Metered dose inhaler plant
Liquid, cream, ointment and suppositories plant
Antibiotic formulation plant
Bangladesh antibiotic limited
Pharmatek plant
Infusion unit
Quality control
Quality assurance
Product development
Engineering, BPL
Production planning
Administration
Project
Training topics:
For new employees:
Induction training is conducted for new employees on
Basic GMP
Safety overview
On-the job
For existing employees:
Train the trainers
GMP
Safety
Utility system
General self development training
On the job training
SOPs
PRODUCTION PLANNING DEPARTMENT
A Pharmacist who works in the Production Planning department has to do multipurpose jobs. The
works that the Production Planning Department generally do have been quoted below:

Quality Control System of Beximco Pharmaceuticals Limited

Issuing of BMR & BPR: The department of Production Planning generally issues BMR and

BPR. If planning finds that change is essential or needed in BMR and BPR, it would do
consultation with the Product Development for its desired change.
Ensuring the availability of raw and packaging materials: For the smooth and favorable

production, the planning has to arrange all kinds of raw and packaging materials by doing
discussion with the Head office of the company.
Arranging Sample for Physician: The physician sample will be separated from the bulk

production by the department of Production as the order of the Planning department.

Arranging products for the foreign market: one pf the important job of the planning

department is to arrange supply the products to the foreign market.

Co-ordinate all departments for smooth production: Planning also co-ordinate different

section of the company to have highest production level within lower total cost and minimum time.
Comparing man-hour and achievement: Planning also compares man hour and

achievement, and by this they know the real efficiency and effectiveness of man and machine.
Keeping reports and other documents of daily production: The department of Planning

also keeps all kinds of every days production reports. Besides, they also maintain the major
documents.
Submitting the monthly reports: It is the duty of the panning department to submit the

monthly production report to the ED, works at the end of the month.
Day wise machine utilization: The planning department has to create daily machine
utilization statement. If any complexity arises in the machine utilization, they have to immediately in
form the higher authority.

From the above discussion it is visible that a Pharmacist who works in the Production Planning
Department of the company has to such kind of multistructured works that require proper
sincerity,

care

and

effectiveness.

WAREHOUSE
Warehouse is the place where materials for the production are stored for further use and
distribution. The Beximco Pharmaceutical Ltd. has a striking warehouse where raw, packaging
and finished products are stored with great care. This warehouse has three units. They are as
followes
BPL Warehouse

BIL Ware-house (Infusion Unit)

Pharmatek Ware-house
There are different segments of the warehouse. They are:
In the Quarantine area raw and packaging materials are preserved for the approval of the
Quality Assurance Department.
In the Released area raw and packaging materials are preserved here with great safety and
care which are approved by the QA. This area is the heart of the ware-house.

Quality Control System of Beximco Pharmaceuticals Limited

Raw materials, packaging material and finished products that fail to get approval from the QA
are retained with a lot of security in the Rejected area.
In the Finished product area generally finished products are installed here for distribution in
the market.
In the Cold Storage area those products are kept that are heat sensitive and flammable
materials.

The work of warehouse is differentiated into two categories. They are:

Routine works
Periodic works

Routine works done by warehouse:

Arrival of materials: Raw & packaging materials arrive at the factory premises by different

Supplier with two copies of delivery challan & invoice.

Invoice checking: The concerned authorities of the warehouse verify the invoice &

accordingly they will check whether the shipping mark is logged on the container or not.
Physical inspection and receipt/Discrepancy report: After completing the physical

inspection of the raw materials, the materials are received on the basis of SOP if there is no
discrepancy.
Quarantine storage: Raw and packaging materials are stored in this stage before the

checking by the QC and approval from the QA.

Log book entry: To entry the actual received quantity of materials into the log book and copy

to MIS Department,Shipping Department, Production Planning (Factory), Warehouse.

MRR for imported items: After receipt of materials, MRR is completed & the quantity of

materials undergoes computer entry to the final stock. Three copies of MRR send to Shipping
Dept, A/C Dept, and Warehouse.
QC sampling: Warehouse authority will inform the QC for sampling and after doing sampling

and analyzing the QC will send the report to the QA.

QA release / reject: On the basis of QC analysis & pass report QA give released tag on each

& individual containeror box. If the material fails to pass QC test, QA give rejected tag on each and
individual container or box.
MRR / Failed MRR: Send copy to A/C Department, Shipping Department, and Warehouse.
Disposition Of released / rejected materials: Released materials are placed in the released

area for dispensing and Rejected materials are placed in the rejected area until further decision for
final disposition is made.
Dispensing: Only the released materials are dispensed as per requisition of production

department following respective SOP.

Distribution: Most of the dispensed materials are carried and supplied to respective

department by Warehouse personnel.

Computer entry of requisition: Inventory updating is done by computer entry of issued

requisition and copy to e-mail for users.

Monthly inventory report: Monthly updated inventory report is sent to MIS Department, A/C
Department, and Purchase Department.

Quality Control System of Beximco Pharmaceuticals Limited

The handling of finished goods is also a routine work of the warehouse. After getting finished
goods transfer note from manufacturing department, the works that are done by the warehouse
are projected below:

Periodic works done by warehouse: (Export in the foreign market)

Export Order: Having information from international marketing department with Invoice,

packing list and export permission issued by Drug Administration.

Apply to custom: To apply for export to customs office with Export from duly filled by

Warehouse invoice, packing list and export permission issued by Drug Administration.
Delivery to C&F agent: In presence of custom inspector materials delivered to C & F agent.
Receipt of airway bill: International marketing department send airway bill for necessary

information & action.

Submission to custom: Paying the air way bill to custom office with monthly return.

Sampling Booth of warehouse:

After reaching the raw material in the warehouse, the QC officer does the sampling of the raw
materials in the sampling booth.
Sampling is done by a sampler that consists of three parts- upper, middle and bottom. The
sampling is done on the basis of FIFO (First in First Out) system. For active ingredients, every
container and for excipient, (n+1) containers are sampled (where n = total number of the
containers).
Dispensing areas of Warehouse:
A dispensing officer is responsible all the time for dispensing the raw materials to the production
and packing materials to the packing areas. Following things should be checked by the
dispensing officer in all phases:

To check that only those materials that are approved have been brought to the dispensing

area.
To check that the area of dispensing is absolutely free from others materials.
To check whether cleaning is done with IPA and savlon solution.
To check that correct quantity and approved quality of materials are being dispensed as per

requisition.
To heck that materials come first are being dispensed first, to follow FIFO (First In First Out).

Miscellaneous things:

There are some other things that are maintained in warehouse. They areTo keep warehouse free from attack of insects and rats, some insect or rat killer devices are

being used.
To protect warehouses material from dust, the building is built in a systematic way such as the

double door system.

Raw materials and finished products are easily identified here with the help of an index which
includes different code for different area also.

Quality Control System of Beximco Pharmaceuticals Limited

Packaging materials in warehouse are kept or placed following Alphabetical order.

SOLID
DOSAGE
FORMULATION
Beximco Pharmas biggest unit is the Solid department which is also the most important
department of any company. From this unit most of the returns on investment come for the

company. Different units of the Solid department have been projected below in the flow chart:
Granulation Unit: Granulation is the process in which powder particles of raw materials are

made to adhere to form larger particles called granules. Granulation done forTo improve the flow of powdered materials by forming sphere like or regularly shaped

aggregates and
To improve the compression characteristics of the mix (blend.)
To prevent segregation of the constituents in the powder mix.

In this unit two types of granulation processes are performed:

1.
Dry Granulation
2.
Wet Granulation
Flow Chart of Granulation
Machineries used in Granulation Unit
(Unit I, II, III,VI)
Name of the machine

Planetary mixer

Purpose
To form wet

Manufacturer

Features

Gansons, India

Unit I : 60 kg

granules

High Speed Mixer

Granulator

Unit II: 120 kg

To form wet

Pharmaceutical and

granules

Medical Supply LTD.

150Kg

Thailand

Multimill

Size reduction &

Gansons, India

Screen size:9.35mm

sieving

Merk industries,

rpm:1500

Bangladesh.

Screen size:2.4mm
rpm:3000

Fluid bed dryer

Granules drying

(Electric heater)

Sapphire, India

Unit I : 60 kg

Gansons, India

Unit II: 120 kg

Unit III: 150 kg (2N)

Vac-U-Max

Granules transfer

Belle-ville, U.S.A

Quality Control System of Beximco Pharmaceuticals Limited

into Tote Bin

Tote Bin

Granules blending

Kurri-Kurri N.S.W.,

with lubricants

Australia

500 Kg

Compression unit: After granulation, the granules are compressed to form tablets of specific
weight, hardness and thickness. Compression unit consists of six compression rooms.

Machineries used in Compression unit

Unit

Machine name

Source

No. of

Channel

Speed(tab/hr)

station
1

Manesty

England

16

Single hopper

Max.35,000

England

35

Double hopper

70,000

D3B
2

Manesty
BB4

Manesty

-210,000
England

35

Double hopper

BB4
4

Sejong

70,000
-290,000

Germany

30

Single hopper

Max. 200,000

Korea

55

Double hopper

Max. 300,000

Korea

45

Double hopper

378000

FETTE1200
5

Sejong
FETTE P3100

Sejong
M45

Sejong

Korea

18

Single

16000 64000

Sejong

Korea

49

Double

8800 420000

Quality Control System of Beximco Pharmaceuticals Limited

Coating unit: Some reasons are responsible for coating tablets. Those are
To improve the pharmaceutical elegance of the product by use of special colors.

To mask the unpleasant taste, odor, or color of the drug.

To control the release of the drug from the tablet.

To protect physical and chemical protection for the drug.

To control dust of the tablet.

Mainly three types of coating are performed in the solid section. They are as followsMachineries used in Coating unit
Unit

Machine

Source

Capacity(Kg)

Speed (rpm)

No. of nozzle/Gun

England

150

5-8

2 Guns

England

150

3-8

12 Nozzles

name
1

Manesty
Accela Cota
150A

Manesty
Accela Cota

or

350A

2 Guns

Manesty

England

350

3-8

12 Nozzles

Accela Cota

or

350B

2 Guns

Sejong

Korea

350

3-8

Pharmatech

12 Nozzles
or
2 Guns

Coating problem: General coating problems that may occur during manufacturing. Those

problems areLogo bridging

Logo infilling
Picking/Sticking
Twinning
Cracking
EDGE Chipping/ Erosion
Core erosion
Peeling
Orange peel/roughness
The above problems can be overcome by following one or more of the following solutions:

Quality Control System of Beximco Pharmaceuticals Limited

Select suitable coating material

Change spray rate
Change drying rate.
Change distance between spray guns and surface of tablet bed.
Change atomizing air pressure.
Change inlet air temperature/air flow
Moreover working experience may help to get quick salvation.
Capsule filling unit:

Machine Name

Source

Stations

Feature

Automatic Capsule Filling

Italy

16

Max. 50,000

Machine MG-2 (MG Futura)

Capsules/Hour.

Packaging Area:
Packing can be defined as an economical means of providing, presentation, protection,
identification/information, containment, convenience, and compliance for a product during
storage, carriage, display and use until such time as the product is used or administered. After
compression of tablets and coating [if required], the tablets are packed either in blister pack or in
the strip.
Primary packaging materials are (source Korea, India):

Polyvinyl Chloride [PVC], (PVC/PVC)

Polyvinyl dichloride [PVDC], (PVC/PVDC)

Blister Foil,

Alu-Alu Foil etc.

Conventional strip foil

Blister Packing Machineries

Machine Name

Origin

Maximum capacity

Pam pac

India

70 strip/min

Klockner Hansel, 085

Germany

84 strip/min

Klockner Hansel, 074

Germany

84 strip/min

OttoHansel,042

Germany

180 strip/min

Otto Hansel, 043

Germany

180 strip/min

Hoong- A

Korea

180 strip/min (5 tracks)

Hemson 073

India

100Strip/min

Stage in Blister packing

Quality Control System of Beximco Pharmaceuticals Limited

Some common Problem in Blister Machine:

Preheating problem malleability
Forming problem
Sealing problem
Slitting problem perforation
Loading problem
Air pressure
Scanner problem
Emboss problem
Heat exchanger
Feeding problem Chute channel, Gate transfer, Spiral, Brush
Strip Packing and Bottle Filling Machineries:

Machine Name

Origin

Maximum capacity

Strpping Machine(Ganson)

India

34 strip/min

Bottle filling machine 063

Taiwan

50 Bottles/ min

Cap sealing machine, 064

India

60 Bottles/ min

Machineries of printing room:

Machine Name

Type

Origin

Prontophot-Hapa. AG

Auto

Switzerland

Sami Auto Printing Machine

Semi-auto

India

KK & KK-2 Printing machine

Auto

Taiwan

RESEARCH AND DEVLOPMENT

Research and Development Department plays an important and innovative role in every step to
establish a new formulation, new dosage form, coating system and their development etc.
Product Development also prepare recipe for the product, formulation order, manufacturing
process, Batch Production on Record (BPR), and data, and development in commercial scale of
a new product. This section always tried to give higher quality product with minimum cost.
Marketing Department
Operation Department
Plant Manager
Research Development Department
Research

Quality Control System of Beximco Pharmaceuticals Limited

Establishment of new Product

Marketing Department
Regulatory Affair Department for approval of the new product by the Drug Administration
Starting of Commercial Production
This department has tow partFunction of Research Development Department:
Research development department deals with the following functions:
1)

Formulation of new product

2)

Reformulation of existing product

3)

Problem solving related to manufacturing

4)

Preparation of BMR and BPR for a new product

5)

Development of existing products.

6)

Analytical method development

7)

Stability study of new product according to stability study protocol.

8)

Preparation of sample for drug testing laboratories (DTL).

Analytical activities:

After production this unit responsible for following activities:

Quality builds up and checks.
Disintegration & dissolution test.
Friability & thickness test.
PH test.
Stability test
Machineries used for RD department:
1. Compression machine
Source: Manesty, England(16 Station)
2. High speed mixture Granulator
Source: Thailand
3. Coating Pan
Accela cota,
Source: Thailand
4. Weighing balance
SHIMADZU UW 6200H
Source: Japan
5. Magnetic stirrer
Gallenkamp,

Quality Control System of Beximco Pharmaceuticals Limited

Source: England
7. Friability tester
Erweka,
Source: Germany
8. HPLC
SHIMADZU Class VP
Source: Japan.
9. Bulk/Tapped Density Tester
Electrolab
10. Magnetic Stirrer and Hot Plate
Gallenkamp
11. Multi-Mil
Source: MSC35 (INDIA)
12. HANNA PH Mixers (Romania)
13. ERWEKA Dissolution Tester
14. NEWTRONIC Stability Chamber
NEWTRONIC (INDIA)
15. MEMMERT Electric Oven (Germany)
16. SHARP Refrigerator
LIQUID DOSAGE FORMULATION
Oral Liquid and Topical Preparation Area is one of the most important area in Beximco
Pharmaceuticals Limited. This section involved with the manufacturing of products like antacids,
non-antacids and semisolids.
Manufacturing area of this section is divided into two Units as follows
1.
Liquid Unit I
2.
Liquid Unit II
Liquid Unit I
This section is divided into the following areas

Area for antacid manufacturing, filling and Packaging.

Area for non-antacid manufacturing, filling and packaging.

Area for cream, ointment and gel manufacturing, filling and packaging area.

Automatic washing room.

Equipment washing room

Bottle washing and autoclave room

Printing room
Liquid Unit II

Quality Control System of Beximco Pharmaceuticals Limited

This section is divided into following sections

Area for oral liquid products manufacturing.
Area for oral liquid filling and packaging.
Area for suppository manufacturing and packaging.
List of Machineries in liquid Section:
Automat Filling & Sealing machine
Greatide Ointment Filling & Sealing Machine
Weighing Balance, Satorious
Gansons Bottle Washing Machine
Heracus Bottle Washing Machine

India

105-106 bottles/hr

Taiwan

2400 tubes/hr

Germany
India

240 bottles/hr

India

Memmert Cap Dryer

Manufacturing & Storage Jacketed Vessel
Manufacturing & Storage Jacketed Vessel
Millipore Filter
Manufacturing Vessel
Avrey Weighing Machine, Gansons
Planetary Mixer
Colloid Mill
Manufacturing Vessel & Storage Tank
Dust Collector
Sarong Suppository Filling & Sealing Machine
Pharmalab Bottle Filling & Sealing Machine
Carton Sealing Machine
Automatic Printing Machine
Semi automatic Printing Machine

Flow Chart of L.C.O & Suppository Operation

Quality Control
Department

Australia

5000 litre

Australia

3000 litre

Germany

50

India

1000,500,200 L

England

50 & 250 kg

India
Germany

100 kg

Australia

3000 litre

Italy
Italy
India

110 bottle/min

Taiwan
Taiwan
China

4000 peak/hr

Quality Control System of Beximco Pharmaceuticals Limited

Quality control department makes all types of chemical assay and chemical analysis find the
result in terms of potency, presence, identity, stability etc. The persons working here are
responsible for the quality of the products. This is actually the analytical part of the plant.

Working Division of Quality Control Department

Analytical section
Microbiology section
Packaging section
Analytical Section:
Analytical section of Quality Control Department performs analytical tests. Analytical tests are

mainly of two types as follows:

Quantitative

Qualitative
Stability Study
Mainly for finished products, Quality Control Department performs stability study. Aim of this study
is to ensure that all batches of the released products are maintaining within specification limits
throughout their entire shelf life.
Stability study is performed according to International Conference on Harmonization (ICH).
Type of Study

Experimental condition

Real time study for climate zone 3 & 4

30 C 2 C temperature
65 5% Relative Humidity

Accelerated study

40 C 2 C temperature
75 5% Relative Humidity

An intermediate stability study is also performed at 30 C 2 C temperatures and 65 5%

relative humidity. If 30C 2C temperature and 65 5% is the long-term condition, there is no
study required for intermediate condition.
Activities of Quality Control Department:
# Sampling
(A quality control officer does it when Raw materials arrive in Warehouse)
# Analysis
(The analyst analyses the sample according to the specification)
# Checking
(After the tests, the results are checked)

Quality Control System of Beximco Pharmaceuticals Limited

# Final approval
(The Q.C manager verifies the result)
# Collection
(A Q.A officer collects the results of the sample that was assigned previously)
Machineries of Analytical Section
Equipment Name

HPLC System & Controller

Karl-fisher titrator

Leica AR-600 Automatic Refratrometer

Brookfield Digital Viscometer

Atomic Absorption Spectrophotometer

IR Prestige 21 (FTIR

Polarimeter
Gas Chromatography

Humidity Control Oven

Humidity Oven

Dissolution Tester 4

Electronic Anal Precision Balance

Disintegration test Apparatus

Apt-Line Kbf Humidity Oven

Melting Point Apparatus

Octagon Sieve Shaker

pH meter

Sonicator

Origin
Shimadzu, Japan
Mettler, Switzerland.
Leica, U.S.A
Brookfield, U.S.A
Aurora, Canada.
Shimadzu, Japan
Atago, Japan

Newtronic Equipment Company, India.

Thermolab, India.
Erweka, Germany.
Sartorius AG, Germany
Erweka, GmbH, Germany.
WTB Binder, GmbH, Germany.
Gallenkanp, England.
UK
Beckman
Ultrawave

Microbiology section:
Microbiology section of Q.C department is performed microbiological tests. Microbiological tests
cover two types of test, one is microbial limit test and another is bioassay of antibiotics.

Quality Control System of Beximco Pharmaceuticals Limited

Activities of microbiological section

Microbial limit test of raw materials and finished products

1.
2.

Total aerobic bacteria and fungal count.

Detection of pathogens like; Salmonella sp, Escherichia coli (E. coli),

Pseudomonas aeruginosa, Staphylococcus aureus.

Microbial assay of raw materials and finished products.
Environmental monitoring
Equipments in Microbiological Section
Name of the Machine

Laminar

Air

Flow

(Bench)

Hot Air Oven

Origin
Airtech Company

Japan
Kottermann-2736

Germany

Autoclave

Apl, Naniwa Ikakgyo Company, Japan

Comments
0.45

HEPA Filter porosity 0.22

180C temperature

for 3 hours is used to sterilize

121C temperature with 15 pound pressure for
15 minutes is used to sterilize the media

Incubator

Memmert md-600

Germany

Rotamixer

Hook & Fucker Instruments, UK

37C temperature to support optimal bacterial

growth.
Proper mixing of Sample and preparation of
Inoculums suspension

Packaging Section
Quality Control Department performs the following tests for packaging materials:
Packaging Materials

Cotton

Shipping carton

Plastic cap

Dropper

Tests
Appearance, weight, moisture content, sulphated ash
Weight, dimension, thickness, appearance
Appearance, weight, length, diameter, volume, capacity
Appearance, weight, length, diameter, volume, capacity, adaptability with bottle,
carton and plastic cover

Mask tape

Water measuring flask

5 ml Spoon (Plastic)

Appearance, width, adhesiveness

Appearance, weight, length, diameter, capacity
Appearance, weight, length, diameter, capacity

Quality Control System of Beximco Pharmaceuticals Limited

Bottles

Height, neck diameter, body diameter, weight, overflow capacity, machine

acceptance, light transmission

(10% allowed)

Inner carton

PVC/PVDC

Label & Literature

Height & level, description, weight dimension

Color, width, thickness
Product name, generic name, batch number,

manufacturing date, expiry date, M.R.P,

QUALITY ASSURANCE
Quality Assurance is an organized department in Beximco Pharmaceuticals Ltd. which deals with
ensuring the quality of the product up to the end user. In1980s the approach for assuring product
quality extended the responsibilities of quality control far beyond the area of testing and
compliance check, and the concept of Quality Assurance was developed:
QA=Product design + GMP + QC + Quality goal activities
The activities of Quality Assurance are as follows:
Approval of source
Checking of Dispensing operation
In process checking of all production area
Product sampling , release
Product complaint handling
Suppliers performance review
Conducting quality audit
Perform all type of Validation activities
Document preparation, editing, control etc.
Retention sample collection, archiving, monitoring, retrieval etc.
Product quality review(Annual/Periodic)
Artwork preparation, checking, finalization for packaging material
Preparation of certificate of analysis for finished formulation and finished API.
Establishing manufacturing methods and SOPs covering entire operations and their regular updating.
Communication of every aspects relating to quality to all relevant persons for early positive
action.
Ensuring product Stability
Ensuring adequate training program.

Quality Control System of Beximco Pharmaceuticals Limited

INFUSION UNIT (LARGE VOLUME PARENTERAL)

WATER TREATMENT PLANT
Sterile products are very sensitive one and should be free from any viable microorganisms. As
water is used as large volume raw materials in infusion preparation and this is directly inject to
blood so purification of water for preparing Water For Injection (WFI) is very important. For this
water treatment plant is a mandatory part of Infusion Unit.

Machineries used in water treatment plant are as follows:

Boiler
Chiller
Air Compressor
Cooling Tower
Rests of the machineries which are used in water treatment plant are given in the following flow
chart:
FLOW CHART OF WATER TREATMENT PLANT
Submersible pump (collection of water from 110-120ft below from earth level)
Erosion Chamber
Multimedia Filter
Over Head Tank
Cl2 Dozing
15micron filter
Reservoir
Activated Carbon Filter
micron filter
micron filter
Ion Exchanger
Mixed Bed
micron filter
micron filter
DM Water Tank
Distillation Plant
Condenser
Distilled Water Tank
Heat Exchanger
Water For Injection (WFI)
Solution preparation area: Functions of solution preparation area are given with a flow chart-

Quality Control System of Beximco Pharmaceuticals Limited

DM water

Cleaning & sterilization of tank

pouring water in tank for

Preparing solution
Sample for QA approval

Stirring

Filtration at pall filter

Addition of raw material

Filtration at pall filter

filling

sending to buffer tank for

(0.22micron)

(2.5 micron)
Bottle Packing: Activities in bottle packing area arePolyethylene

Extrude

Sealing

Mould

Cap welding

Blowing & Filling

Punching

Autoclave: Autoclave is one of the most important area in manufacturing sterile dosage forms.
In autoclave, sterilization is done at 106C temperature at chamber pressure 2.1 bar and steam
pressure 1 bar for 85 minutes.
Packaging: Activities of packaging area area) Visual inspection (cap spot, body spot, mechanical stress, deformation)
b) Bottle checking in pressing belt & manual sorting of defective bottles
c) Labeling on bottles
d) Over bagging & printing through jet printer on over bag
e) Over bag sealing
f) Master cartooning
Machineries Used in BPL
EQUIPMENT

Injection Moulding machine( Superjack )

ORIGIN

FEATURE

Germany

Capacity : 12 ounce
( 180 PC )

Electronic balance( Rhewa )

Taiwan

Vessel-1 ( solution Vessel )

Germany

Capacity : 3000 liter

Vessel-2 ( Gentinge )

Germany

Capacity : 3000 litre

Muller device

Germany

Bottle Packing, Filling & Sealing machine

( Bottle Pack Type 302 )

Germany

Bottle Packing, Filling & Sealing machine

( Schuma )

Germany

Capacity : 785 pcs 1000ml

bottle / hr.

Quality Control System of Beximco Pharmaceuticals Limited

Filter Checking Machine

( Paltronic )

Assembling Machine
( Rubber Filling )

Autoclave
( Sauter-Sulgen ; Gentinge )

Blue Bath Tester

Germany

Germany
Used for leakage testing of
bottle

Pressure/ conveyer Belt

Germany

Pressure used : 0.3 0.5

Bar

Labelling Machine
( Avery )

Air Sealing Machine

( Impulse Autosealer )

Inkjet Printer
( Jaine 1000 )

Germany
Taiwan
Germany

QUALITY ASSURANCE IN INFUSION UNIT:

QA department plays a vital role in infusion area. QA tests are performed in each and every step
in manufacturing infusions. Providing quality, safe products is the main responsibility of QA
department.
Activities of QA department in infusion unit are given below with a flowchart.
Receiving of MRI
Visual inspection of RM & PM
Sampling of RM & PM
Q.C., chemical & microbiological testing of RM & PM
After preparation of solution assay and pH checking of sample
ENGINEERING
SERVICES & UTILTIES
Beximco Pharmaceuticals Ltd.has an independent engineering department for looking after
production and utility machineries. Responsibilities of engineering department are to install,
maintain, handle and solve all types of problems such as electrical, electronic and mechanical.
Utility support is very much important for smooth operation of all production machineries.
CONCERNED AREA OF ENGINEERING DEPARTMENT

Quality Control System of Beximco Pharmaceuticals Limited

Engineering Department is concerned for operation and maintenance of utility machines and
provide,

1. Power Supply
2. Water System
3. Steam Supply
4. Gas Supply
5. Compressed Air Supply

6. Central Air conditioning System

Engineering Department is also concerned for maintenance of all production machineries.
Maintenance can be classified into two different categories-

a) Schedule/ Preventive maintenance:

All the all production machineries are checked routinely (weekly, monthly etc) for ensuring
efficient operation and minimum breakdown.
b) Breakdown maintenance:
Breakdown maintenance is done when any machine is out of control due to mechanical,
electronic or electrical problem.
FLOW CHART OF MAINTENANCE PROCEDURE OF ENGINEERING DEPARTMENT
Planning for maintenance
Requirement of skilled and trainer manpower (Personnel)
Availability of required materials (Parts of machines)
Execution of work
1. Water pump:
NAME
Deep tube well

MODEL
310b/9

Deep tube well37B/10

MOTAR MODEL
Siemens 40HP
Siemens 10HP

2. Air compressor:
a. Model: Compressor 145-SR
Air end: single stage oil injected screw
Cooling: Air cooled
Oil capacity; 18.50usgal
Delivery air pressure: min bar (psig) -5(72)
Max bar (psig) -13 (189)
Motor speed: 5000rpm
b. Model: Compressor l: 30
Rotary Screw Compressor

CAPACITY
9000gal/hrs

Quality Control System of Beximco Pharmaceuticals Limited

Out put4.49cun/min at 9bar

c. Broom wade air compressor
Oil free air compressor
Capacity: 300cfm at 7 h
3. Fire tube boiler
Mfg: WHOSUNG
Origin: USA
Model: a.CIW700200150
b. CIW7000125150
4. Chiller
DUNBUM-BOOL
Model: ACF155-S
Capacity: 1,845,600 BTU/Hr.
They perform maintenance works by two ways
Routine/preventive/schedule maintenance : check weekly which include
1. Cleaning
2. Greasing and oiling
3. Change bearing
4. Checking
5. Inspection
Breakdown
5. Generator 11/4 KUA substation for electrical supply
Manufacturer

Capacity

Engine model

Generator model

Enginator model

Origin

G1 WAUKESHA

920KW

17042GSI

A248810001

VHP7100GSI

USA

G2 WAUKESHA

1020KW

3516

G3 WAUKESHA

900KW

15794GSI

VHP5904GSID

G4 WAUKESHA

900KW

15794GSI

VHP5904GSID

USA

RECOMMENDATIONS
We all know that Beximco pharmaceuticals Ltd. never compromise regarding the quality of the
product. BPL follows the guidelines of the cGMP and maintenance the standards from the very
beginning of the production procedure to distribution in the market & keeps record of all

Quality Control System of Beximco Pharmaceuticals Limited

documents. That is why there is hardly any scope of rendering any suggestion for its further
modification.
But some recommendations can be given
Effluent Treatment Plant may be set up as early as possible though BEXIMCO Pharma already

ensured the destruction of hazardous wastes safely in contract basis with icddrb.
Opportunities for the trainee may be given to visit TRACK-II and MDI.
Capsule polishing machine is needed to reduce manufacturing time.
We hope Beximco Pharmaceuticals Ltd. will Manufacture Soft gelatin capsule.

FINDINGS AND ANALYSIS

During our training program in Beximco Pharmaeuticals Ltd. we have found the following

findings:
Beximco Pharmaeuticals Ltd. strictly follows the rules and regulations of cGMP.
Beximco Pharmaeuticals Ltd. has got the TGA approval of Australia this year.
Beximco Pharmaeuticals Ltd. is going to introduce small volume parenterals(SVP).
Enough paste control device is available inside the plant.
A separated Sampling Booth is available in warehouse where temperature, humidity, and

pressure is controlled.
Rejected materials are kept locked to reduce the possibility of mix-up with the released

material.
Hazardous wastes are destructed safely by the collaboration with icddrb.
Beximco Pharmaeuticals Ltd. has a separated training department.
Central Warehouse of Beximco Pharmaeuticals Ltd. is very large and well arranged.
Quality Control department is well equipped.
RD department is self sufficient for the development of new product.

EXECUTIVE SUMMERY
BEXIMCO Pharmaceuticals is the second largest company in Bangladesh. Though Beximco is a
local company but they follow multinational culture. They also maintain a chain of command. After
the 1982 drug policy, they go their own formulation and in a short period they acquired crown of
success. In case of coating Beximco is the pioneer. They believe quality is first. And to ensure
quality they have excellent facility and no. of experience & skilled personnel who are contributing
for that. It has a wide range of product line such as solid, semisolid, liquid, ointment, cream,
suppository etc. BEXIMCO Infusions and MDI have the best facilities and utilities than that of
other production areas. These areas are highly specified and maintaining aseptic technique. MDI
of BEXIMCO undergoes contact manufacturing with Glaxo Smith Kline (GSK).BEXIMCO
Infusions operating a well organized water treatment plant Pharmaplan imported from Germany,
which makes BEXIMCO one step ahead of other infusion plants in Bangladesh.

Quality Control System of Beximco Pharmaceuticals Limited

BEXIMCO allays maintains GMP and cGMP over production areas. They have validated SOP,
Process validation system, equipped Microbiology section, and cleaning procedure. They also
have air lock system laundry for cleaning cloths and waste disposal system.
BEXIMCO have Quality Control and Quality Assurance Department that are responsible for the
quality of the product in every step of production phenomena. And their documentation is
excellent.
BEXIMCO Pharmaceuticals have Human Resources & Training Department, devoted to make
skilled employee while engineering department is ensuring proper operations of machineries,
electric and electronic equipment during production. Its safety measure for the employees is
excellent.
CONCLUSION
I had a strong desire to gather practical knowledge during my in-plant training from BEXIMCO
Pharmaceuticals Ltd. is the leading pharmaceutical industry in Bangladesh. Its contribution for
the development of national economy is well known. BEXIMCO Pharma having a pioneering role
in exporting pharmaceuticals from Bangladesh. The plant layout of the Beximco pharma. Ltd. is
excellent and well organized. They have large area and they can easily extension of plant if it is
necessary.
The 2 weeks in-plant training helps us to understand the steps of tablet coating, method of
granulation, compression, Liquid filling, aseptic condition and much difficult topics of
pharmaceuticals.
During in-plant training, we got lots of co-operation from every people of every section and we
delighted for their friendly approach. We satisfied and produto have the modern knowledge and
practical experience from a well reputed factory like Beximco Pharmaceuticals Ltd. This
practical knowledge will help us in my future professional life.
BIBLIOGRAPY
1.

All Department of Beximco pharmaceuticals Ltd.

2.

Half yearly Report