introduction, mission, history, production unit, animal health, Manufacturing science and technology, quality control, production planning, supply chain management, admin & IR

1. Industrial Training Overview on
Novartis Bangladesh Limited (Tongi Plant)
PreparedBy
B.Pharm Professional Year-IV 2015 Exam

2. Introduction
Company Profile :
Name : Novartis Bangladesh Limited
Scope Of Business : Human Pharmaceutical, Animal Health Products , Consumer
Health Products
Sales Office : Country wide 11 sales office
Head Office : AHN tower(7th floor) 13 Bir Uttam C.R. Dutta Road
Phone : +880 9606 300300 , +88 02 8615302
E-mail : novartis@bol-online.com
Website : http://www.Novartis.com.bd
Shareholders : Novartis International AG,Switzerland (60%)
Bangladesh Chemical Industries Corporation (40%)
Plant : Novartis Bangladesh Limited,Tongi Plant Cherag Ali
Market,Tongi,Gazipur
Phone : (8802) 9810728-31

3. A Brief History Of Novartis

4. Mission of Novartis
• We want to discover, develop and successfully market innovative products
to cure diseases, to ease suffering, and to enhance the quality of life. We
also want to provide a shareholder return that reflects outstanding
performance and to adequately reward those who invest ideas and work
in our company.
• We want to be recognized for having a positive impact on people's lives
with our products, meeting needs and even surpassing external
expectations.
• We want to contribute to society through our economic contribution,
through the positive environmental and social benefits of our products,
and through open dialogue with our stakeholders.

5. Production Department (Plant A)
Units of the production department are:
1. DISPENSING UNIT
2. GRANULATION UNIT
3. COMPRESSION UNIT
4. COATING UNIT
5. ENCAPSULATION UNIT
6. PACKAGING UNIT - primary & secondary

6. Dispensing Unit
The dispensing unit is divided into thee areas:
 Dispensing unit A
 Dispensing unit A1
 Dispensing unit B
Major functions of dispensing unit are:
• To prevent cross contamination
• Weighing of materials (excipients first, then API)
• To reduce operator’s exposure to powder
• To receive materials from warehouse as per DOS
• Attachment of dispensing label on each dispensed container

7. Machines in Dispensing Unit
• Weighing machine:
Mettler: toledo(34 kg)
Mettler: IDS, T-2000 (0.4-240kg)
Made in Switzerland
• Standard calibration weight:
Mettler (Switzerland)
• Air exhaust system
• Water supply system:
Hot, normal & de-ionized water
Mettler Weighing Machines

8. Granulation Unit
The granulation unit is divided into four areas:
 Granulation area A
 Granulation area A1
 Granulation area A2
 Granulation area A3
Purpose:
• To prevent dust contamination by maintaining negative pressure in the granulation area
• To prevent segregation of constituents in the powder mix
• To improve flow properties of powder
• To improve compression nature of powder

9. Machines in Granulation Area
• Granulator:
T.K Fielder(German), Yenchen (Taiwan)
• FBD:
Aeromatic(Swiss), Yenchen(Taiwan),
Solace(India)
• Milling machine:
Fitz Mill (German), Multi Mill (India)
• Grinding machine:
Frewitt (Swiss)
• Final Blending Device:
LLB final blending machine, Double cone mixer
(India), LLB final blending machine
Drum mixer
• Stainless steel container
Bhole container (German),
Artofex container (Swiss) Yenchen granulator and fluid bed dryer

10. Compression Unit
When the granulation is done the final granules are stored in a container and then it is
delivered to the compression unit for compression. It is also divided into three units
named A, A1 & B.
Parameters to be checked:
• Proper cleaning of machine.
• Proper arrangement of the die and punch.
• Removal of all the materials relevant to previous product.
• HVAC system.
• Humidity.
• Temperature.
• Pressure differential during pre-compression and compression phase.

11. Machines in Compression Unit
• Compression machine:
Manesty Unipress(England),
Sejong(Korea-30 stations, single
rotary),
Clit Press(India-29 stations, double
rotary)
• Balance: Mettler PM 4600
• Vacuum cleaner(Italy)
• Tablet deduster
• Dehumidifier
Manesty Unipress

12. Coating Unit
A layer of polymer or sugar is applied on the core of the tablet. Some coating materials are:
Sugar, acrylic polymer, methacrylic acid polymer, cellulose derivatives, ethyl acetate etc.
Purpose:
• Avoid inactivation of drug in the stomach
• Mask bad taste
• Improve dosing interval
• Reduce influence of moisture and atmosphere
• Improve appearance and acceptability
• Increase market appeal
• Attracting pediatric and younger patients

13. Machines in Coating Unit
• Coating machine:
Manesty Accela Cota(England),
N.R Cota(Thailand), Sejong(Korea)
• Stainless steel container:
Hanag
• Pump: Watson Marlow
• Homogenizer: Pedrollo(Italy)
• Balance: Mettler PM 4600
Manesty Accela Cota(England),

14. Encapsulation
Capsules are solid dosage forms in which the drug substance is enclosed in a hard / soft gelatin,
soluble container or shell of a suitable form of gelatin.
Capsules are of two types:
•Hard gelatin capsule
•Soft gelatin capsule
Machines available in Encapsulation Unit:
 Machine: BOSCH (German)
Channel: Single
CPM: 300
CPH: 18,000
Output: 36 (per rotation)
 Balance: Mettler PM2000
Maximum: 2 kg
Minimum: Not defined.
BOSCH Encapsulation

15. Packaging
Purpose:
• To increase stability of the drug
• To increase the acceptability of the drug
• To minimize the transport hazard
• To improve patient compliance
Packaging can be divided into three ways:
i. Primary packaging
ii. Secondary packaging
iii. Tertiary packaging

16. Primary Packaging
Three types:
Blister packaging
Strip packaging
Bottle filling & sealing
Machines used for the Primary Blister Packaging:
CAM1
 CAM 2
 Ottohansel(manual)
 Uhlmann
Printing machine:
HAPAmatic (Swiss) CAM automatic blister packaging

17. Secondary Packaging
Secondary Packaging Materials:
 Plastics
 Paper containers and cartons
The labeling contains the following Information:
 Batch No.
 Manufacturing Date
 Expiry date

18. Popular Products Of Novartis Bangladesh Ltd.
Brand Name Generic Pack Size Price(MRP)
AZYTH 500 Azithromycin 500mg x10’s 300.00
SETIC Cefixime 200mg x 14’s 420.00
SERVIFLOX Ciprofloxacin 250mg x 30’s 242.70
RIMSTAR 4-FDC Rifampicin+Isoniazid+Pyrazinamide
+Ethambutol
900mg x 50’s 376.50
PROBITOR Omeprazole 20mg x 60’s 420.00
VOLTALIN Diclofenac 25mg x100’s 305.00
BINOCLAR Clarithromycin 250/500mg x 40’s 495.60
SANDOCAL-D Calcium+Vitamin D 500mg x 50’s 350.00
CALCIUM SANDOZ Calcium Carbonate 250mg x 50’s 175.00
TEGRETOL Carbamazipine 200mg x 50’s 326.50

19. Production Department (Plant C)
The Animal Health business unit in Bangladesh is dedicated to maintaining and improving the health of
farm animal since 1977.
Production Facilities:
• Dispensing Unit
• Granulation Unit
Machines:
Double cone blender
Multimill
FBD
Planetary mixer
• Compression Unit
• Sachet filling Unit
• Packaging Unit

20. Popular Animal Health Products of Novartis
Name Generic Name Pack Size Product Type
Digitop Ammonium
bicarbonate, nux
vomica
20x20 Pack Dairy
Fasinex Triclabendazole 10x4 Dairy
Ralinex levamisol 10x4 Dairy
Geotox Mineral oxides 25 kg Aqua
Chlorsteclin Chlortetracycline 1kg Poultry
Cinoflox Enrofloxacin HCl 10x100 Poultry
Coxiclin Diclazuril 25 kg Poultry

21. QUALITY ASSURANCE DEPARTMENT
Quality Assurance/ QA Department is divided into two major categories:
i. Quality Compliance
ii. Quality Control.
Quality Compliance:
In Novartis (Bangladesh) Limited, Quality compliance department use
mainly SAP software. External or Global audit is performed after every 2
years by the officials of
1.EU
2.MCC (South Africa)
3.ANVISA (Brazil)
Internal audit or internal self inspection is performed 2 times in a year.
At present five people are working in Quality compliance.

22. In Process Quality Control
• The main function of IPQC is to give line clearance in every steps of
production like dispensing, granulation, compression, coating and packaging.
• It also ensures proper cleaning of the machine and production area after
each batch.
Line clearance is given after following functions:
• Clearance
• Cleaning
• Inspection by operator
• Verification by IPQC using specific guidelines of GMP

23. QUALITY CONTROL
According to GMP Quality control can be defined broadly as the regular
control of quality ensured by pharmacist and technicians responsible for
the acceptance or rejection of incoming raw materials and packaging
components.
According to the function, Q.C is divided into three parts.
They are :
1.FDF analysis section
2.Logistic Department
3.Microbiological section

24. Instruments In QC Lab
NO. Instrument Manufacturer
1 Digital Ultrasonic Bath Power Sonic 520
2 Milli-Q Water System Quantum Ex, Gra
3 Digital Shaker G.F.L
4 Digital Centrifuge Machine BOECO(Germany)
5 Disintegration Tester DT2
6 Vacuum Dryer Salvis
7 Muffle Furnace Carbolite
8 Dissolution Apparatus 3 Electrolab
9 Dissolution Apparatus 1,5,6(USP 4) Sotax
10 pH meter Seven Compact

25. Instruments In QC Lab
NO. Instrument Manufacturer
11 UV spectrometer Spectronic UNICAM UV
12 Digital Polarimeter Anton Paov
13 Gas Chromatography Agilent 7890A
14 TOC Analyzer Shimadzu
15 HPLC System 1 Agilent 1260
16 HPLC System 2 Shimadzu Prominence Single
Pump
17 HPLC System 3 Shimadzu 1500
18 HPLC System 4 Agilent 1100
19 HPLC System 5 Dionex UH 3000
20 HPLC System 6 Dionex Ultimate 3000

26. Instruments In QC Lab
NO. Instrument Manufacturer
21 HPLC System 7 Dionex RSLC
22 Particle Size Analyzer Malvern Aeros
23 Karl Fischer Titrator Metrohm
24 Analytical Balance Mettler Toledo
25 FTIR Shimadzu
26 Microbalance Mettler
27 Incubator 1,2,3,4,5 Heraue/WTC binder
28 Moisture Analyzer Mettler
29 Tap Density Tester LOGAN
30 Autoclave 01 Systec

27. Manufacturing Science and Technology Department
MS&T department is divided into five units, they are:
1.Galenical Development Unit
2.Analytical Development Unit
3.Product Migration Unit
4.Plant Machineries Unit
5.Packaging Product
Objectives:
• Develop BMR that ensures smooth production
• Development of better quality products
• Discover ways of cost effectiveness
• Technology transfer

28. Instruments in MS&T Department
Instruments name Manufacturer name Country
Fluid bed dryer (1 piece) Solace India
Planetary Mixer (1 piece) Solace India
Balance (1 piece) Mettler PE 600 Germany
Multi-mill (1 piece) Solace India
NR Cota machine
(1 piece)
N.R. Industries Germany
Compression Machine
(1 piece)
Jaguar India
Cap. Sealing machine
( 1 piece)
Marks (India) private limited India

29. SUPPLY CHAIN MANAGEMENT DEPARTMENT
It has the following five functional divisions:
1.Material Management
2.Procurement
3.Export
4.Ware house
5.Vat and customs

30. Production Planning
Product planning is an important department in Novartis
(Bangladesh) limited. They develop the planning for the operation of the
plant. There main objective is to prepare an upcoming 18 months plan
for manufacturing operation of the plant. This is reevaluated after every
one month. In this 18 months planning there aim is to meet the global
and local requirements by analyzing GROFO (Global Rolling
Forecasting Order) and ROFO (Rolling Forecasting Order).
By analyzing these data product planning department decides
the quantity of raw materials, HALB and PERT production. Here HALB
means semi finished product and PERT is the final product before
packaging. The word HALB and PERT are German words. Only Novartis
uses this two terms in the pharmaceutical sector in Bangladesh.

31. Warehouse
According to GMP a pharmaceutical Warehouse should have the facility of controlling
and maintaining of temperature and humidity as per the needs of the material stored.
At Novartis the warehouse maintains three different types of temperature zone depending
on products merit:
Cold - (2° C to 8° C)
Cool - (8°C to 20° C)
Room temperature (24° C ± 2° C)
Functions:
• Receiving in-voice and purchase order & materials
• Labeling & Documentation
• Storing materials in different room temperature based on product merit.
• Market analysis
• Production support

32. Health Safety And Environment (HSE) Department
To minimize the risk of hazard Novartis Bangladesh has a health, safety &
environment department. This provides the safety for both human and
wealth. Normally safety means, prevention from all unwanted or
unintentional harm.
Hazard means source of any kind of harm. Hazard can be,
Task associated hazard
Location related hazard
Material related hazard
Fatality
Accident Observation
Near Miss
Hazard Identification

33. Technical Service Department
Technical Service Department is a supportive service department in any pharmaceutical
industry, which exercises its activities and duties through maintenance and repairing of the
electrical and mechanical devices & other facilities of the industry. They provide all sorts of
engineering and technical supports in the industry whenever necessary.
Instruments used for the supply support :
Electricity
Generator
Compressed Air
HVAC system
Cold Water/Hot Water/Water Supply
Deionized water plant
Effluent Treatment Plant(ETP)

34. Admin & IR Department
Tools Used:
• Payroll
• Employee Relation & Welfare
• Planning/Counselling
Individual Functions:
• Stationary
• Transport facility
• Canteen
• Gardening
• Security
• Seating
• Laundry (In house)
• Accidental benefit