Industrial Training Overview on

Novartis Bangladesh Limited (Tongi Plant)

Prepared By

B.Pharm Professional Year-IV 2015 Exam

IntroductionCompany Profile :Name : Novartis Bangladesh LimitedScope Of Business : Human Pharmaceutical, Animal Health Products , Consumer

Health ProductsSales Office : Country wide 11 sales officeHead Office : AHN tower(7th floor) 13 Bir Uttam C.R. Dutta RoadPhone : +880 9606 300300 , +88 02 8615302E-mail : novartis@bol-online.comWebsite : http://www.Novartis.com.bdShareholders : Novartis International AG,Switzerland (60%)

Bangladesh Chemical Industries Corporation (40%)Plant : Novartis Bangladesh Limited,Tongi Plant Cherag Ali

Market,Tongi,GazipurPhone : (8802) 9810728-31

A Brief History Of Novartis

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.

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

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

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 waterMettler Weighing Machines

Granulation UnitThe 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

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 containerBhole container (German),Artofex container (Swiss) Yenchen granulator and fluid bed dryer

Compression UnitWhen 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.

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

Coating UnitA 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

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),

EncapsulationCapsules 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 capsuleMachines available in Encapsulation Unit: Machine: BOSCH (German)

Channel: SingleCPM: 300CPH: 18,000Output: 36 (per rotation)

Balance: Mettler PM2000Maximum: 2 kg Minimum: Not defined.

BOSCH Encapsulation

PackagingPurpose:

• 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

Primary PackagingThree 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

Secondary Packaging

Secondary Packaging Materials:

Plastics

Paper containers and cartons

The labeling contains the following Information:

Batch No.

Manufacturing Date

Expiry date

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

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

Popular Animal Health Products of Novartis

Name Generic Name Pack Size Product Type

Digitop Ammoniumbicarbonate, nuxvomica

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

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.

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

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

Instruments In QC LabNO. 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

Instruments In QC LabNO. 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

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

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

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

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

Production PlanningProduct 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 HALBmeans 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.

WarehouseAccording 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

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

Technical Service DepartmentTechnical 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 :

ElectricityGeneratorCompressed AirHVAC systemCold Water/Hot Water/Water SupplyDeionized water plantEffluent Treatment Plant(ETP)

Admin & IR DepartmentTools Used:

• Payroll

• Employee Relation & Welfare

• Planning/Counselling

Individual Functions:

• Stationary

• Transport facility

• Canteen

• Gardening

• Security

• Seating

• Laundry (In house)

• Accidental benefit