Quality Control System of Beximco Pharmaceuticals Ltd

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


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 5th 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, PeoplesRepublic 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

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

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

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:


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.

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.


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, (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:

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 are-

To keep warehouse free from 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.

Raw materials and finished products are easily identified here with the help of an index which

includes different code for different area also.

Packaging materials in 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:

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 for-

To 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 Purpose Manufacturer Features

Planetary mixer To form wet

granules

Gansons, India Unit I : 60 kg

Unit II: 120 kg

High Speed Mixer

GranulatorTo 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

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

station

Channel Speed(tab/hr)

1 Manesty

D3B

England 16 Single hopper Max.35,000

2 Manesty

BB4

England 35 Double hopper 70,000

-210,000

3 Manesty

BB4

England 35 Double hopper 70,000

-290,000

4 Sejong

FETTE1200

Germany 30 Single hopper Max. 200,000

5 Sejong

FETTE P3100

Korea 55 Double hopper Max. 300,000

6 Sejong

M45

Korea 45 Double hopper 378000

7 Sejong Korea 18 Single 16000 – 64000

8 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.

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-

Machineries used in Coating unit

Unit Machine

name

Source Capacity(Kg) Speed (rpm) No. of nozzle/Gun

1 Manesty

Accela Cota

150A

England 150 5-8 2 Guns

2 Manesty

Accela Cota

350A

England 150 3-8 12 Nozzles

or

2 Guns

3 Manesty

Accela Cota

350B

England 350 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 Source Stations Feature

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 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

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

Ø 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

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 MachineTaiwan 2400 tubes/hr

Weighing Balance, SatoriousGermany

Gansons Bottle Washing MachineIndia 240 bottles/hr

Heracus Bottle Washing MachineIndia

Memmert Cap Dryer

Manufacturing & Storage Jacketed VesselAustralia 5000 litre

Manufacturing & Storage Jacketed VesselAustralia 3000 litre

Millipore FilterGermany 50 μ

Manufacturing VesselIndia 1000,500,200 L

Avrey Weighing Machine, GansonsEngland 50 & 250 kg

Planetary MixerIndia

Colloid MillGermany 100 kg

Manufacturing Vessel & Storage TankAustralia 3000 litre

Dust CollectorItaly

Sarong Suppository Filling & Sealing MachineItaly

Pharmalab Bottle Filling & Sealing MachineIndia 110 bottle/min

Carton Sealing MachineTaiwan

Automatic Printing MachineTaiwan 4000 peak/hr

Semi automatic Printing MachineChina

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

Equipment Name Origin

HPLC System & Controller Shimadzu, Japan

Karl-fisher titrator Mettler, Switzerland.

Leica AR-600 Automatic Refratrometer Leica, U.S.A

Brookfield Digital Viscometer Brookfield, U.S.A

Atomic Absorption Spectrophotometer Aurora, Canada.

IR Prestige 21 (FTIR Shimadzu, Japan

Polarimeter

Gas ChromatographyAtago, Japan

Humidity Control Oven Newtronic Equipment Company, India.

Humidity Oven Thermolab, India.

Dissolution Tester 4 Erweka, Germany.

Electronic Anal Precision Balance Sartorius AG, Germany

Disintegration test Apparatus Erweka, GmbH, Germany.

Apt-Line Kbf Humidity Oven WTB Binder, GmbH, Germany.

Melting Point Apparatus Gallenkanp, England.

Octagon Sieve Shaker UK

pH meter Beckman

Sonicator 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.


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

Hot Air Oven Kottermann-2736

Germany

180ºC temperature

for 3 hours is used to sterilize

Autoclave Apl, 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.

Rotamixer Hook & 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

5 ml Spoon (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

Label & 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.


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-


DM water Cleaning & sterilization of tank pouring water in tank for

Preparing solution

Sample for QA approval Stirring Addition of raw material

Filtration at pall filter Filtration at pall filter sending to buffer tank for

filling (0.22micron)

(2.5 micron)

Bottle Packing: Activities in bottle packing area are-

Polyethylene Extrude Mould Blowing & Filling

Sealing Cap welding Punching

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

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

( Bottle Pack Type 302 )Germany Capacity : 785 pcs 1000ml

bottle / hr.

Bottle Packing, Filling & Sealing machine

( Schuma )Germany


Filter Checking Machine

( Paltronic )Germany

Assembling Machine

( Rubber Filling )

Autoclave

( Sauter-Sulgen ; Gentinge )Germany

Blue Bath Tester Used for leakage testing of

bottle

Pressure/ conveyer Belt Germany Pressure used : 0.3– 0.5

Bar

Labelling Machine

( Avery )Germany

Air Sealing Machine

( Impulse Autosealer )Taiwan

Inkjet Printer

( Jaine 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.

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


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 MODEL MOTAR MODEL CAPACITY

Deep tube well 310b/9 Siemens 40HP

Deep tube well37B/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

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 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.

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.


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

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Quality Control System of Beximco Pharmaceuticals Ltd

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