1. TRAINING REPORT
NOVARTIS PHARMA OTC, JAMSHORO
2014
SUBMITTED BY : ARIFA JABEEN MEMON
2K9/PHARM-D/09
3/3/2014

2. DURATION OF TRAINING:
40 DAYS
20 JAN TO 28 FEB, 2014
SUBMITTED TO:
NOVARTIS PHARMA-OTC,
JAMSHORO, PAKISTAN
SUBMITTED BY:
ROLL NO: 2K9/PHA/09 (MORNING)
ARIFA JABEEN MEMON
Pharm D EXAM -2013
FACULTY OF PHARMACY
SINDH UNIVERSITY JAMSHORO

3. Acknowledgements
My thanks to Novartis, Jamshoro Pakistan Limited for giving me the opportunity
to complete my industrial training. I am deeply grateful to all those who have,
with their good grace, given me their valuable time and energy to express their rich
full experience about the instrumental terms, conditions and working procedures. I
particularly want to acknowledge the tremendously helpful, supportive, creative
contributions of all the heads of Production , QA and Warehouse . I owe a special
thanks to my training coordinator for her contribution and polite behavior.
Finally, my thanks to my Faculty Dean, who has arranged such type of profession
related training to gather professional experience.

4. COMPANY HISTORY
Novartis is a world leader in the research and development of products to protect and improve
health and well-being. The company has core businesses in pharmaceuticals, vaccines, consumer
health, generics, eye care and animal health.
Headquartered in Basel, Switzerland, Novartis employs nearly 115,000 people in over 140
countries worldwide to help save lives and improve the quality of life. The Group is present in
Pakistan through Novartis Pakistan Limited.
Renamed to Novartis following an acquisition by Ciba-
Geigy, it owns Sandoz, a large manufacturer of generic
drugs. The company formerly owned the Gerber Products
Company, a major infant and baby products producer, but
sold it to Nestlé on 1 September 2007.
Novartis is a full member of the European Federation of
Pharmaceutical Industries and Associations (EFPIA) and
of the International Federation of Pharmaceutical
Manufacturers and Associations (IFPMA).
After the merger, Novartis reorganized its operating units
and spun out its chemical activities as Ciba Specialty
Chemicals (now a part of BASF).

5. OBSERVATION
ORIENTATION AND DEPARTMENTS OF THE
INDUSTRY:
The company complies of the following departments in pharmaceutical sectors and
I have visited all the departments as trainees. The departments’ are-
Production Area
I. Dispensing.
II. Granulation.
III. Compression.
IV. Encapsulation.
V. Coating.
VI. Filling and sealing.
VII. Packaging.
Quality Assurance Department.
I. Quality control.
II. In-process control.
Ware House:
 Raw material warehouse
 Packaging material ware house
 Finished good warehouse

6. STANDARD OPERATING PROCEDURE SOP’s:
A set of fixed instructions/ steps for carrying out usually routine job.
To achieve uniformity of perfomanceof specific function.
23 SOPs followed by this process.
Philosphy of SOP:
Source
For
Search
Obedience
For
Operation
Plan
For
Perfomance
Need For SOP’s:
 Written record of process
 Ensure compliance with regulation and guidelines
 Ensure quality of data
 Facilitate audit and inspection
 Assure global acceptance

7. PRODUCTION
The process by which active ingredient and excipients are received from ware
house into the production area and weighing materials according to dispensing
order sheet (DOS) is called dispensing.
In case of different batch of same product, excipients of both batches are weighted
first then active ingredients are weighted and in the last flavours nd colour are
weighed. Active must be wrapped in double polythene bags. There is no need of
change over of instrument used in production area. This process reduces the
possibility of contamination.
Instruments available:
• Balance.
• Hepa filters
• Laminar air flow
• Scoops and other utensils.

8. Granulation is the process in which powder particles are made to adhere to form
larger particles called granules. Granules are usually used in the production of
tablets or capsules.
Purpose of granulation:
 Granulation prevents segregation of the constituents in the powder mix.
 It improves the flow properties of the powder mix.
 It improves compression nature of powder.
 Granulation I is for large scale where FBD capacity: 120 KG and
Granulation II for small scale production where FBD capacity : 60 KG
 Mostly tablets are formed by wet granulation xcept Anuva and Ternelin
tablet , capsules are formed by wet granulation.
Types of granulation:
Two types of granulation techniques are used-
 Dry granulation:
This method is applied for drugs which do not compress well after wet
granulation or those which are sensitive to moisture.
 Wet granulation:
Wet granulation involves the massing of the powder mix using a solvent.
The solvents used must be volatile, so that they can be removed by
drying, and nontoxic.

9. - IN PROCESS : QALSAN –D Orange
BATCH NO: JO643
BATCH SIZE: 792KG
Area line Clearence IPC
UNLOAD
Dry Granulation
Raw material
Dispensing
Sieving
Mix, dissolve and
kneed
Drying 40-60 min
Check LOD
Collete grall
Glatt (fludized
bed drier)
Frewitt sieve
1500u
HalogenMoisture
Analyser

10. IN PROCESS:
Manually in P.E bags
Impact forward speed
Capacity 1000 kg ,23 rpm , clockwise for 24 min
Unload , Check LOD
QA
Label Work in process WIP
BLENDING
Wire sieve 1500u
Mix material
Frewitt sieve 800u
Fitzmill Sieve 0020
Scholl mixer
WeighAll Drums
COMPRESSION
Product: Ca-C 1000 Plus
BATCH NO :J4454
BATCH SIZE:780 KG

11. Compression of powder means reduction in bulk volume of a material as a result of
displacement of the gaseous phase. Compression technique used for the
manufacture of tablet.
Machines available:
• Manesty BB4-35 (35 punches)
• Killian TX-32 (32 punches)
• Uni press (20 punches)
• Manesty D3-A (20 punches)
• Korsch P300 (36 punches)
• RTS-32 (32 punches)
• BOSCH GKF-400 Capsulation Machine
 Korsch Ph22(22 punches)
Tablet manufacture problem:
Θ Punch filming and sticking.
Θ Weight variation.
Θ Capping/lamination.
Θ Mottling.
Θ High friability.
Θ Variable hardness
Θ Bisection or embossing

12. It is the process by which a layer of polymer or sugar applied on core tablet for
various reasons is called coating.
Types:
 Sugar coating.
 Film coating.
 Enteric coating.
EQUIPMENTS:
 Thai Coater 49 capacity 2kg-400kg
 Coating Pan
 DJ vessel capacity 300L
 Mixing vessel capacity200L
Sugar coating:
Sugar coating is the traditional method of coating tablet. It involves the successive
application of sucrose-based solutions to tablet cores in suitable coating equipment.
Sugar coating is a multistage process and can be divided into the following steps:
Sealing of the tablet cores , Sub coating , Smoothing, Coloring and Polishing .
Used Steps:
 Lacquering
 Application of Talc suspension
 Application of colourless sugar layer
 Drying
 Polishing.

13. Film coating:
Film coating is a modern technique of coating procedure requires very small time
compared to sugar coating. It involves less steps and coating problem.
Steps:
 Introduction of liquor solution.
 Coloring.
 Polishing
ENTERIC COATED TABLET:
This technique is used to protect the tablet core from disintegration in the acid
environment of the stomach for one or more of the following reasons:
 Prevention of acid attack on active constituents unstable at low pH.
 To protect the stomach from the irritant effect of certain drugs.
 To facilitate absorption of a drug that is preferentially absorbed distal to the
stomach.
Standard coating pan:
The standard coating pan consists of a circular metal pan mounted on a stand. The
pan is 8 to 60 inch in diameter and rotated on its horizontal axis by a motor. Heated
air is directed in to the pan and on to the tablet bed surface and is exhausted by
means of ducts positioned in front of
the pan.
The coating solutions are applied by
spraying the material on to the rotating
tablet bed. One of the chief drawbacks
of standard coating pan is the poor
drying efficiency due to poor
distribution of hot drying air.

14. The significant improvement in the drying efficiency of the standard coating pan is
achieved by the pellegrini pan, the immersion sword and the immersion tube
systems.
The pellegrini system has a baffled pan and a diffuser that distributes the drying air
uniformly over the tablet bed.
Spray Application systems :
two basic types of the systems used to apply a finely divided (atomized) spray of coating
solutions on the tablets are:
High pressure, air less : the liquid is pumped at high pressure (250- 3000 psig) through a small
orifice of 0.009 to 0.020 inch diameter in the fluid nozzle, which results in finely divided spray.
The degree of atomization and the spray rate are controlled by the fluid pressure, orifice size and
viscosity of the liquid.
Low pressure, air atomized system : the liquid is pumped through a somewhat larger
orifice(0.020 to 0.060 inch) at relatively low pressure(5 to15 psig) The low pressure air contacts
the liquid stream at the tip of the atomizer and a finely divided spray is produced.
Factors considered during coating procedure:
I. coating pan Speed.
II. Inlet air velocity.
III. Pressure of air inside coating pan.
IV. Inlet air temperature.
V. Outlet air temperature.
VI. Relative humidity.
VII. Atomization air pressure.
VIII. Liquid spray rate.
IX. Gun nozzles check.
X. Droplet size.
XI. Drying time

15. ENCAPSULATION:
Encapsulation is the process of
manufacture of capsule. Capsules are solid
dosage forms in which the drug substance
is enclosed in either a hard or soft, soluble
container or shell of a suitable form of
gelatin.
Types of capsule:
Hard gelatin capsule:
It is referred to as the dry filled capsule; consist of two sections, one slipping over
the other, thus completely surrounding the drug formulation.
Soft gelatin capsule:
It is a soft, globular, gelatin shell, somewhat thicker than that of hard gelatin
capsules. The gelation is plasticized by the addition of glecerin, sorbitol or a
similar polyol .
Machines available:
◊ Machine: BOSH GKF400
Channel: Single.
CPM: 300; CPH: 18,000.
Output: 36 (per-rotation)

16. Primary packaging:
In case of primary packaging, packaging material comes to the direct contact of the
finished goods. So its quality should be strictly maintained.
Blister packaging:
Blister packaging involves forming heat softened plastic film or around a deep-
drawn pocketed mold to make a plastic tray (thermoforming), filling with a solid
dosage form product and sealing with push through or peel able covering.
Composition:
Heat softened plastic film:
Chemically films used are polymer in nature. Polymers used are polyethylene (PE),
poly vinyl chloride (PVC), poly vinyl di-chloride (PVDC) etc. Films used may be
of one, two or three layered; depending on nature (moisture sensitivity) of finished
product. Its thickness may vary from 250-300 micrometer.
Covering materials:
Covering material is usually preprinted or plane aluminum. Its standard thickness
is about 25 micrometer. The covering material has a printing primer on one side
and a heat sealing lacquer on the other, which faces the product and forming film.
Strip packaging:
A strip package is formed by feeding two webs of a heat sealable flexible film
through a heated roller. The product is dropped into the pocket formed prior to
forming the final set of seals.
Machines:
Packaging machine:
Name: CAM (Auto), THRIVE BLISTER, ULHMANN (manual /Auto), NOACK
( manual/Auto).

17. Printing machine:
Name: Hapamatic.
Operating temperature:
Heating temperature: 130° C (formation of pocket).
Sealing temperature: 160° C (sealing of film and cover).
Steps of packaging procedure:
Formation of pocket for product (tablet or capsule) using heat softened plastic film.
Introduction of product into pocket (manually or mechanically).
Scissor /Cutting.
Conveying to packaging section by conveying belt
Sealing of product by covering material (printed or without printed).

18. CalciumSandoz , CaC- 1000 and CaC-1000 plus are 3 major running item of
novartis.
Machines:
• FETTE-17 (17 punches)
• KORSHXL400
• 2GD Wrapping filling Machine
• Masiba filling Machine
• Copro tighting macine
• 3M Sealing machine.
COMPRESSION AND WRAPPING:
Under this sub-section effervescent calcium tablets are manufactured with different
flavor.
After scholl mixing the powders are compressed to form a solid unit dosage form
(tablet) which is wrapped in an aluminum foil and packed into plastic tubes and
after silica gel insertion spiral plug is fixed and final packaging is proceeded.
1 tube 10 tablets T-10
Pack size 40 tubes.
Seal and stamp packrite and transfer to Finished goods warehouse.

19. In Process :
Product: Qalsan D STB (strawberry)
Batch no:J0497
Machines:
• Rotex filling machine
• Enercon sealing machine
• Strunk labeling machine
Procedure:
IPC monitor will Check area line clearance, batch number,product name..amd QA
give approval. Load the tablets and start tablet filling operation pointer is set on 30
tablets. Insert silice gel inside bottle, screw cap manually seal by induction sealing
machine.. label batch no, mfg, exp, According to (SP42) . final packing 30 packs in
1 packrite seal packrite 3M sealing machine.label and sign packrite.for loose
packrite partial case slip. In the last Transfer the pallet to F.G ware house .

20. Syrup dispensing room :
Flammable or Fuming ingredient are dispensed.
Syrup manufacturing room :
1. S.S preparation vessel, double jacketed , Capacity:2500L
2. S.S mixing vessel, Capacity 4000L
Solvent storage room:
Bulk quantity of syrup is stored in Tank.
Tank no1: Mosegar syrup B.No J0227
Tank no2: Sancos syrup B.No J1263
Tank no3: T-Day syrup B.NoJ0666
Tank no4: Sancos syrup B.No J1262
Tank no 5: unwashed last product was Tegral

21. PROCESS FLOW OF SYRUP MANUFACTURING
IN PROCESS
Dispensing
Syrup manufacturing
Preparation
Bulk liquid and solution transfer
From prep:vessel to mixing vessel
Mixing tank
Filtration
Storage Tank
PRODUCT: sancos syrup
BATCH No: J1259
B.SIZE: 4000L
Sugar phase
Preservativesandflavorphase
Active phase
15 Cartidge filter
75u
Volume makeup
4000L
Capacity 2500L
L/C, Verification
IPC
QA draw
sample

22. In process
Dispensing of packaging material
Bottle Air blowing
Syrup Filling
Optical check
Labelling
Cartoning
Final packaging F.G warehouse
Amber glass bottle,
caps pilfer proof 25mm
burgundy
Hi worth Air blowing
SPL filling/capping machine
SPL labeling machine
30 bottles in 1 packrite, seal
sign and weigh .. load on
pallet
QA
Product:sancos syrup
B.No:J1259
Pack size :120ml

23. EQUIPMENTS USED FOR THE MANUFACTURING OF SEMI SOLIDS:
 MDLTO-MAT (1 OOKG)
 THAI-HOMOGENISER(25OKG)
 GASTI IMMERSION PUMP
 NORDEN TUBE FILLING MACHINE.
PRODUCTS:
 VOLTRAL 1% EMULGEL. (Batch size:250 Kg ;Pack size: 15g)
 LAMISIL 1% CREAM. (Batch size 100 kg ; Pack size 10g)
 DERMAZIN CREAM. (Batch size 200 kg ; Packsize 25g, 50g, 250g )
IN PROCESS:
• Product: Dermazin Cream
• Batch no: J0470
• Batch size 200 kg
Indication : Burns
Active : Sulphadiazine silver salt
Steps:
 Preparation of oily phase (fatty phase)
 Preparation of basic emulsion
 Preparation of active phase (API suspension)
In process Control Specifications:
• Colour: White
• Appearance: Homogenous cream
• PH: 4.7

24. Semi finshed storage QA approved
Dispensing of Packaging material
Tube filling
Manual packing
Late stage customization
Final packaging
Weighing
QA (approved)
F.G warehouse
 Pack design
 Pack approval
 printart work,
 batch codesetc
Plaincarton , leaflet and
laser print Exp & mfg

25. QUALITY ASSURANCE
Quality assurance department co-ordinate the functions of following four departments:
• In process control department.
• Quality control department.
• Good manufacturing practice (GMP) department.
• Quality compliance department.
In process control department
Instruments available:
◊ Friabilator:
It is used to determine the capacity of tablet to withstand shock during coating, packaging and
shipment. It is expressed as percentage.
Friability (%) = (1-W2 / W1)100
Hardness tester:
Name: Pharmatron.
Tablet hardness is the important measurement of IPC; as it control the disintegration time of the
tablet and also size of tablet.
Disintegrator:
Name: Sotax DT3.
Disintegration is the process of conversion of tablet into smaller particle. Core tablet
disintegration performed in deionized water (temp-37.4°C). Enteric coated tablet disintegration
time determined in 0.1% HCl solution.

26. Leak test apparatus:
Name: Ketan
It is used to determine packaging accuracy. Some time colored solution used to
find leak in packaged product.
◊ Loss on drying apparatus:
Name: Metler
It is used to determine moisture content of material, Usually during drying, before
compression and during coating. IR radiation is used in this instrument. Moisture
content expressed as percentage. It is an important factor as weight of tablet
compensate according to moisture of granule.
Responsibilities:
 Receiving of Right materials in right condition from ware-house.
 Cleanliness of dispensing area. Presence of production officer , Random
weighing of material. Accurate tag used or not. Balance is calibrated or not.
 Assure cleanliness of granulator, dryer etc. According to Standard Operating
Procedure (SOP) instrument cleaned before 15 days can be used in
granulation procedure ,Temperature of inlet and outlet air.Moisture content
of dried granules.
 Package (blister and strip) imprint. Visualization of tablet inside the
package. Cleanliness of packaging area and instrument
 Environment monitoring.
 Sanitation and cleaning.
 Machine validation assuring. Etc.
So the quality assurance personnel are always conscious about the quality of the
product by taking consideration into above factors. It requires large manpower to
do all the functions accurately.

27. Quality control department:
Quality control refers to the process of striving to produce a perfect product by a
series of measures to prevent or eliminate errors in production
Documentation Raw material Finished goods Packaging
material
Validation of-
• DOS.
• POS.
• SOP.
• BMR.
Maintenance of log book of
instruments.
Data input of various tests
in BMR.
Name of materials.
Sampling of materials.
Descriptions.
Solubility.
Identity:
• IR absorption.
• UV absorption.
• Chromatography.
• Melting point.
Assay.
Purity and quality.
Microbial limit
Description.
Identity.
• UV absorption.
• Chromatography.
Assay.
Dissolution.
Impurities.
Microbial limit
Packaging
materials:
• Printing.
• Color.
• Message.
With product:
• Batch no.
• Exp date.
• Printing

28. Instruments in Q.C. lab:
 High performance liquid chromatography (HPLC) AGILENT & KNAEUR
 Karl fischer titrator( Metrohm)
 FTNIR- Genesis
 Particle size analyzer
 Viscometer: ( Brookfield) Dissolution tester.
 PH meter.
 Gaschromatography
 Tap density tester (Vanderkamp)
 TOC analyser (siever900 )
 Polarimeter
 DL28 Titrator (mettler Toledo)
 UV analyser (CAMAG reprostar)
Microbiology laboratory:
Functions:
Microbiology laboratory is the part of quality control. It has following
responsibilities-
• Microbial limit test (For bacteria and fungi).
• Antibiotic assay.
• Microbial content of environment.
Microbial limit test:
For the following materials microbial limit test is performed .
Packaging materials:
1.Primary packaging materials(both blister and strip foils)
2.Secondary packaging materials(polybag used in bulk supply )
Raw materials.
Finished materials.

29. Non-pathogenic micro-
organism
Acceptable limit Media used
Bacteria 103 CFT/gm TSA
Fungi 102CFT/gm SDA
Pathogenic microorganism Acceptable limit Media used
E. coli 0 VRBDA
Salmonella 0 XLDA
Pseudomonas aeruginosa 0 R2A
Staphylococcus aureus 0 BPA
Microbial limit test performed for the validation batches (usually first 5 batches)
then MLT performed after a definite batch interval.
Methods:
Presence of microbial contamination performed by the following steps-
• Media preparation.
• Autoclaving.
• Specific method for specific organism.
• Incubation.
• Colony count
Instruments:
To conduct the above steps following instruments are used-
◊ Autoclave (Microbial media sterilized by using the condition temperature 121°C,
pressure 15 Psi for 15-20 minutes).
◊ Incubator (three types of incubator are available; one control temp. between 30-
35°C other between 20-25°C and25-30°C . Use of incubator depends upon
microbial type).

30. ◊ Horizontal laminar-flow (Use to transfer MO to the media without external
contamination .
0.4-0.6 m/s air velocity , HEPA filter 99.9% clean air .
Good manufacturing practice (GMP) department:
This department overview/ inspect the function of total production system. This
department has no routine work but work in every where to inspect/ assure good
manufacturing practice.
Quality compliance department:
This department deals with the problems arises in other production related
department. Here some people are always engage to solve the problem. It is absent
in the plant, related personnel solve their problem through discussion with proper
personnel. It is essential for a quality concern department, because the problem
arises if not solve by proper hand may reduce productivity.

31. Ware house is a store room to store raw materials, packaging materials and
finished goods.
The main functions of ware house are given below:
a. Receiving in-voice and purchase order from material management.
b. Receiving materials.
c. Cleaning of received materials.
d. Weighing of received materials and compare with purchase order.
e. Dispensing of materials according to DOS for production.
f. Receiving of finished goods from production.
g. Inventory of tool manufacture also maintain by ware house.
h. Documentation.
According to Q.C. release:
a. Q.C. released materials (green marked).
b. Quarantine materials (not yet released by Q.C. department – yellow marked).
Special features:
 Presence of Q.C. sampling room inside the ware house.
 Novartis storage category (Nsc) easy Locate the material.
 Flammable materials store at different area- not inside the ware house.
 Fire safety obtained by using temperature and smoke sensor.

32. Raw material ware house:
 As a result of a purchase order generated by the material management the
consignment arrives at ware house in raw material storage area.
 Receipt of RM is made along with entry into concerned log book
 Ware house officer checks all the documents arrived along with RM (COA
etc)
 Material offloading on cleaned pallets with proper stacking.
 Concerned documentation is carried out
 GIR (goods inventory reports) are made in the system (SAP) and the
nomenclature is pasted with a label bearing all information.
 GIR sent to QA with sample for testing
 QA test are performed status is defined (approve or reject).
 With the approval the material is shifted to approve area with the material
bearing QA approved label for dispensing.
PACKAGING WARE HOUSE:
Same steps are followed as RM ware house but difference is the packaging
material samples are sent to packaging lab for full complete testing and after the
approval the labels are pasted by the concerned lab officer.
All the packaging material is dispensed one two day prior to the desired packaging
schedule.
FINISHED GOODS WARE HOUSE:
 Receipt is received from the production (stock transfer note also called as
invoice)
 Check the physical condition and separated defected goods.
 QA clearance form is made and one copy is returned to production
 After checking and verification of pallets the quantity is transferred into the
respected area (ampoules into the cool storage room etc)
 Approved stamp to be passed STN on QA after analysis.

33.  Data entry in the system (SAP)
 Final dispatch of the batch as per replenishment.
Computer system frequently being employed is SAP (system application database
processing)
Three types of distributors all over Pakistan :
 Paraselsous distributor (14 depos)
 Premier (14 depos)
 Regional distributors (45 depos)

34. CONCLUSION
Pharmacy is a professional subject. As a student of pharmacy department,
I need to have theoretical as well as practical and industrial knowledge. In-
plant training helped me to acquire knowledge on drug manufacture and
manufacture management; and it will be very much useful in my
professional life. I am concluding my report by giving thanks to God and
also those who has to face hard work for me. Wish prosper of Novartis
(Jamshoro) Limited day by day.