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Quality Control System of Beximco Pharmaceuticals LTD
Quality Control System of Beximco Pharmaceuticals LTD
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
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
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.
Maintaining liaison with Government Regulatory bodies: HRD keeps relation with the
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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
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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
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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
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
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:
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
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
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.
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.
Arrival of materials: Raw & packaging materials arrive at the factory premises by different
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
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
& 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
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:
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
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
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.
Planetary mixer
Purpose
To form wet
Manufacturer
Features
Gansons, India
Unit I : 60 kg
granules
To form wet
Pharmaceutical and
granules
150Kg
Thailand
Multimill
Gansons, India
Screen size:9.35mm
sieving
Merk industries,
rpm:1500
Bangladesh.
Screen size:2.4mm
rpm:3000
Granules drying
(Electric heater)
Sapphire, India
Unit I : 60 kg
Gansons, India
Vac-U-Max
Granules transfer
Belle-ville, U.S.A
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.
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
Coating unit: Some reasons are responsible for coating tablets. Those are
To improve the pharmaceutical elegance of the product by use of special colors.
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
Machine Name
Source
Stations
Feature
Italy
16
Max. 50,000
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):
Blister Foil,
Machine Name
Origin
Maximum capacity
Pam pac
India
70 strip/min
Germany
84 strip/min
Germany
84 strip/min
OttoHansel,042
Germany
180 strip/min
Germany
180 strip/min
Hoong- A
Korea
Hemson 073
India
100Strip/min
Machine Name
Origin
Maximum capacity
Strpping Machine(Ganson)
India
34 strip/min
Taiwan
50 Bottles/ min
India
60 Bottles/ min
Machine Name
Type
Origin
Prontophot-Hapa. AG
Auto
Switzerland
Semi-auto
India
Auto
Taiwan
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Analytical activities:
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 cream, ointment and gel manufacturing, filling and packaging area.
Printing room
Liquid Unit II
India
105-106 bottles/hr
Taiwan
2400 tubes/hr
Germany
India
240 bottles/hr
India
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 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.
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
30 C 2 C temperature
65 5% Relative Humidity
Accelerated study
40 C 2 C temperature
75 5% Relative Humidity
# 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
Karl-fisher titrator
IR Prestige 21 (FTIR
Polarimeter
Gas Chromatography
Humidity Oven
Dissolution Tester 4
pH meter
Sonicator
Origin
Shimadzu, Japan
Mettler, Switzerland.
Leica, U.S.A
Brookfield, U.S.A
Aurora, Canada.
Shimadzu, Japan
Atago, Japan
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.
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Laminar
Air
Flow
(Bench)
Origin
Airtech Company
Japan
Kottermann-2736
Germany
Autoclave
Comments
0.45
Incubator
Memmert md-600
Germany
Rotamixer
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
5 ml Spoon (Plastic)
Bottles
(10% allowed)
Inner carton
PVC/PVDC
DM water
Preparing solution
Sample for QA approval
Stirring
filling
(0.22micron)
(2.5 micron)
Bottle Packing: Activities in bottle packing area arePolyethylene
Extrude
Sealing
Mould
Cap welding
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
ORIGIN
FEATURE
Germany
Capacity : 12 ounce
( 180 PC )
Taiwan
Germany
Vessel-2 ( Gentinge )
Germany
Muller device
Germany
Germany
Germany
Assembling Machine
( Rubber Filling )
Autoclave
( Sauter-Sulgen ; Gentinge )
Germany
Germany
Used for leakage testing of
bottle
Germany
Labelling Machine
( Avery )
Inkjet Printer
( Jaine 1000 )
Germany
Taiwan
Germany
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
MODEL
310b/9
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
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
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:
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.
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
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