The pharmaceutical industry in Bangladesh is one of the most developed technology sectors

within Bangladesh. Manufacturers produce insulin , hormones , and cancer drugs. This sector
provides 97% of the total medicinal requirement of the local market. The industry also exports
medicines to global markets, including Europe. Pharmaceutical companies are expanding their
business with the aim to expand the export market.

Beximco Pharmaceuticals Ltd (Beximco Pharma) is an emerging generic drug player committed
to providing access to affordable medicines. Company’s state-of-the-art manufacturing facilities
have been accredited by the regulatory authorities of USA, Australia, European Union, Canada,
and Brazil, among others, and it currently focuses on building presence in many emerging and
developed markets around the world.

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.
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
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 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.
Maintaining liaison with Government Regulatory bodies: HRD keeps relation with the following
Government regulatory bodies for the legal aid. Or helps in any accident or medical aid:
1. Ministry of Health, Peoples Republic of Bangladesh
2. Office of Directors of Labor
3. Explosive departments
4. Director of fire and the fire station of Tongi
5. Toni thana, NSI, DB and SB
6. The Pourosova of Tongi
7. Customs and Vat, Tongi circle
8. Office of the Deputy Commissioner, Gazipur
9. Office of the Superintendent of Police, gazipur
10. 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 file
that integrate all kinds of leaves like-
1. Annual leave
2. Medical leave
3. Casual leave
4. Special leave
5. Maternity leave
6. 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. To supervise transport tools (distribution, repair and maintenance)
2. To supervise canteen management.
3. 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 follows-
Induction of training for safety Data Sheet (MSDS)
Taking preventive action for fire and taking preventive measures handling chemicals machineries
and providing awareness & safety Equipment (PPE) procedure up program using different colors
on them according to the standards goods by using different symbols on them according to the
standards Alarming System with smoke & heat detector 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
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
SOP’s
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: 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. 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. Physician: The physician sample will be separated from the bulk production by
the department of Production as the order of the Planning department. foreign market: one pf the
important job of the planning department is to arrange supply the products to the foreign market.
Co-ordinate all smooth production: Planning also co-ordinate different section of the company to
have highest production level within lower total cost and minimum time. achievement: Planning
also compares man hour and achievement, and by this they know the real efficiency and
effectiveness of man and machine. 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. 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.
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: packaging materials arrive at the factory premises by different
Supplier with two copies of delivery challan & invoice. 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.
packaging materials are stored in this stage before the checking by the QC and approval from the
QA. actual received quantity of materials into the log book and copy to MIS Department,
Shipping Department, Production Planning (Factory),
Warehouse. 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. authority will inform the QC for sampling and after doing sampling and analyzing the
QC will send the report to the QA. basis of QC analysis & pass report QA give ‘released tag’
on each & individual container or 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.
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.
materials are dispensed as per requisition of production department following respective SOP.
dispensed materials are carried and supplied to respective department by Warehouse personnel.
Inventory updating is done by computer entry of issued requisition and copy to e-mail for users.
Monthly updated inventory report is sent to MIS Department, A/C Department, and Purchase
Department.
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:
Flow Chart of Handling of Finished Goods by Warehouse
Periodic works done by warehouse: (Export in the foreign market) information from international
marketing department with Invoice, packing list and export permission issued by Drug
Administration. export to customs office with Export from duly filled by Warehouse invoice,
packing list and export permission issued by Drug Administration. presence of custom inspector
materials delivered to C & F agent . International marketing department send airway bill for
necessary information & action. 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, (Ön+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: materials that are approved have been brought to the dispensing area.
dispensing is absolutely free from others materials. done with IPA and savlon solution. and
approved quality of materials are being dispensed as per requisition. 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 are- attack of insects and rats,
some insect or rat killer devices are being used.
To protect warehouse’s material from dust, the building is built in a systematic way such as the
double door system. products are easily identified here with the help of an index which includes
different code for different area also. warehouse are kept or placed following Alphabetical order.
SOLID DOSAGE FORMULATION:
Beximco Pharma’s 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:
Manufacturing Area the process in which powder particles of raw materials are made to adhere to
form larger particles called granules. Granulation done for- powdered materials by forming sphere
like or regularly shaped aggregates and characteristics of the mix (blend.) constituents in the
powder mix.
In this unit two types of granulation processes are performed:
1. Dry Granulation
Flow Chart of Granulation
Machineries used in Granulation Unit
(Unit I, II, III,VI)
Name of the machine
Purpose Manufacturer Features
Planetary mixer
To form wet granules
Gansons, India Unit I : 60 kg
Unit II: 120 kg
High Speed Mixer Granulator
To form wet granules
Pharmaceutical and Medical Supply LTD. Thailand
150Kg
Multimill Size reduction & sieving
Gansons, India
Merk industries, Bangladesh.
Screen size:9.35mm
rpm:1500
Screen size:2.4mm
rpm:3000
Fluid bed dryer (Electric heater)
Granules drying
Sapphire, India
Gansons, India
Unit I : 60 kg
Unit II: 120 kg
Unit III: 150 kg (2N)
Vac-U-Max
Granules transfer into Tote Bin
Belle-ville, U.S.A
–
Tote Bin Granules blending with lubricants
Kurri-Kurri N.S.W., Australia
500 Kg
ulation, the granules are compressed to form tablets of specific weight, hardness and thickness.
Compression unit consists of six compression rooms.
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 follows-
~Flow Chart of different types of coating~
Machineries used in Coating unit
UnitMachine name
Source Capacity(Kg)
Speed (rpm)
No. of nozzle/Gun
1 Manesty Accela Cota 150A
England150 5-8 2 Guns
2 Manesty Accela Cota 350A
England150 3-8 12 Nozzles
or
2 Guns
3 Manesty Accela Cota 350B
England350 3-8 12 Nozzles
or
2 Guns
4 Sejong Pharmatech
Korea 350 3-8 12 Nozzles
or
2 Guns
Coating problem: General coating problems that may occur during manufacturing. Those
problems are-
Logo 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:
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
SourceStationsFeature
Automatic Capsule Filling Machine MG-2 (MG Futura)
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) :
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
Germany84 strip/min
Klockner Hansel, 074
Germany84 strip/min
OttoHansel,042Germany180 strip/min
Otto Hansel, 043
Germany180 strip/min
Hoong- A Korea 180 strip/min (5 tracks)
Hemson 073 India 100Strip/min
Stage in Blister packing
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
Stage in Strip packing
o Printing Area:
To print-
Batch No.,
Expire Date,
Mfg. Date.
Ø Machineries of printing room:
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
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 part-
Function 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,
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
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
India 105-106 bottles/hr
Greatide Ointment Filling & Sealing Machine
Taiwan 2400 tubes/hr
Weighing Balance, Satorious
Germany
Gansons Bottle Washing Machine
India 240 bottles/hr
Heracus Bottle Washing Machine
India
Memmert Cap Dryer
Manufacturing & Storage Jacketed Vessel
Australia5000 litre
Manufacturing & Storage Jacketed Vessel
Australia3000 litre
Millipore FilterGermany50 μ
Manufacturing Vessel
India 1000,500,200 L
Avrey Weighing Machine, Gansons
England 50 & 250 kg
Planetary Mixer
India
Colloid Mill Germany100 kg
Manufacturing Vessel & Storage Tank
Australia3000 litre
Dust CollectorItaly
Sarong Suppository Filling & Sealing Machine
Italy
Pharmalab Bottle Filling & Sealing Machine
India 110 bottle/min
Carton Sealing Machine
Taiwan
Automatic Printing Machine
Taiwan 4000 peak/hr
Semi automatic Printing Machine
China
Flow Chart of L.C.O & Suppository Operation
Quality Control Department:
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
30º C ± 2º C temperature
65 ± 5% Relative Humidity
Accelerated study
40º C ± 2º C temperature
75 ± 5% Relative Humidity
An intermediate stability study is also performed at 30º C ± 2 º C temperatures and 65 ± 5%
relative humidity. If 30ºC ± 2ºC 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)
# 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
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.
Activities of microbiological section
Microbial limit test of raw materials and finished products
1. Total aerobic bacteria and fungal count.
2. 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
Origin Comments
Laminar Air Flow (Bench)
Airtech Company
Japan
0.45μ
HEPA Filter porosity 0.22 μ Oven
Kottermann-2736
Germany
180ºC temperature
for 3 hours is used to sterilize
AutoclaveApl, Naniwa Ikakgyo Company, Japan
121ºC temperature with 15 pound pressure for 15 minutes is used to sterilize the media
Incubator Memmert md-600
Germany
37ºC temperature to support optimal bacterial growth.
RotamixerHook & Fucker Instruments, UK
Proper mixing of Sample and preparation of Inoculums suspension
Packaging Section
Quality Control Department performs the following tests for packaging materials:
Packaging Materials
Tests
Cotton Appearance, weight, moisture content, sulphated ash
Shipping carton
Weight, dimension, thickness, appearance
Plastic cap Appearance, weight, length, diameter, volume, capacity
Dropper Appearance, weight, length, diameter, volume, capacity, adaptability with bottle, carton
and plastic cover
Mask tape Appearance, width, adhesiveness
Water measuring flask
Appearance, weight, length, diameter, capacity (Plastic)
Appearance, weight, length, diameter, capacity
Bottles Height, neck diameter, body diameter, weight, overflow capacity, machine acceptance,
light transmission
(10% allowed)
Inner carton Height & level, description, weight dimension
PVC/PVDC Color, width, thickness Literature
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
Supplier’s 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 up-
dating.
Communication of every aspects relating to quality to all relevant persons for early positive
action.
Ensuring product Stability
Ensuring adequate training program.
Flow Chart Activities of QA Department
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:
Submersible pump (collection of water from 110-120ft below from earth level)
Erosion Chamber
Multimedia Filter
Over Head Tank
Cl Dozing
15micron filter
Reservoir
Activated Carbon Filter
micron filter
micron filter
Ion Exchanger
Mixed Bed
Water For Injection (WFI)
Solution preparation area:
Functions of solution preparation area are given with a flow chart-
Autoclave: Autoclave is one of the most important area in manufacturing sterile dosage forms. In
autoclave, sterilization is done at 106°C temperature at chamber pressure 2.1 bar and steam
pressure 1 bar for 85 minutes.
Packaging: Activities of packaging area are-
a) 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
Manufacturing Procedure:
Machineries Used in BPL
EQUIPMENT ORIGIN FEATURE
Injection Moulding machine( Superjack )
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 Type 302 )
Germany Capacity : 785 pcs 1000ml bottle / hr.
Bottle Packing, Filling & Sealing machine
( Schuma )
Germany
Filter Checking Machine
( Paltronic )
Germany
Assembling Machine Filling )
AutoclaveSulgen ; Gentinge )
Germany Tester
Used for leakage testing of bottle
Pressure/ conveyer Belt
Germany Pressure used : 0.3– 0.5 Bar
Labelling Machine
( Avery )
Germany Machine Autosealer )
Taiwan
Inkjet Printer 1000 )
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.
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 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 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 MODEL
MOTAR MODEL CAPACITY
Deep tube well 310b/9 Siemens 40HP
Deep tube well 37B/10
Siemens 10HP 9000gal/hrs
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
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: ACF×155-S
Capacity: 1,845,600 BTU/Hr.
They perform maintenance works by two ways
1. Routine/preventive/schedule maintenance : check weekly which include
1. Cleaning
2. Greasing and oiling
3. Change bearing
4. Checking
5. Inspection
5. Generator 11/4 KUA substation for electrical supply
ManufacturerCapacityEngine model
Generator model
Enginator model
Origin
G1 WAUKESHA
920KW 17042GSIA248810001VHP7100GSI USA
G2 WAUKESHA
1020KW 3516 USA
G3 WAUKESHA
900KW 15794GSI VHP5904GSID
G4 WAUKESHA
900KW 15794GSI VHP5904GSID
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. may be given to
visit TRACK-II and MDI. needed to reduce manufacturing time. Pharmaceuticals Ltd. will
Manufacture Soft gelatin capsule.
FINDINGS AND ANALYSIS
During our training program in
Beximco Pharmaeuticals Ltd. we have found the following findings: strictly follows the rules and
regulations of cGMP. has got the TGA approval of Australia this year. going to introduce small
volume parenterals(SVP). available inside the plant. available in warehouse where temperature,
humidity, and pressure is controlled. locked to reduce the possibility of mix-up with the released
material. destructed safely by the collaboration with icddrb. has a separated training department.
Pharmaeuticals Ltd. is very large and well arranged. well equipped. for the development of new
product.
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