About Us

Ind-Swift Limited is a fully integrated Company, known around the World for its research and
development initiatives and breakthroughs. It is supported by world class manufacturing
facilities accredited with ISO , GMP and WHO certifications. All products will be manufactured
at GMP standards and scheduled compliance manufacturing units.Nova division is primarily
aimed of providing quality products of multi specialty range.
We are looking for established franchisee partners for all states of India who have their own field
force for the area desired to be covered.
Responding to the call of international marketing opportunities, Ind-Swift Ltd set up the
dedicated Global Business Unit in 2006 as a 100% export oriented unit for finished dosage
forms.

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PROFILE
Established in 1986 by the Jains, Mehtas and Munjals, Ind-Swift is a
leading pharmaceutical manufacturing and marketing company in India, based in Chandigarh.
Its strength lies in innovative pharmaceutical products. Ind-Swift has been ranked 35th in the
Indian pharma industry and is the second largest among the drug manufacturers in India (north
India). It has spread its network across 45 countries. It is an ISO 9001-2008, WHO GMP
certified company. It is also listed on the Bombay Stock Exchange and National Stock
Exchange. It has 5 plants in India which include multi-purpose, multi-location facilities spread
across northern India.
The facilities are built according to the current guidelines of MHRA, EU, WHO and
accreditations with ISO 14000 series standards. The company has world class expertise in
finished goods dosage, Active Pharmaceutical Ingredients (API’s) and herbal products. A
talented team of research scientists, formulation experts, clinical development and regulatory
affairs professionals support the company's marketing efforts not only across the country but also
around the globe. Ind-Swift pharmaceutical products are safe, effective and have consistent
quality.

Research & Development

Research & Development for all types of Pharmaceutical formulations of Ind-Swift Ltd. is
located at 123, Phase-I, Industrial Area, Panchkula (Haryana), India.
Recognized by Dept. of Scientific and Industrial Research, Ministry of Science & Technology,
Govt. of India, New Delhi since 1995.

Is equipped with latest and sophisticated equipments in both of its sections – Formulation
Development & Analytical Development. This along with a very good, qualified and dedicated
team of R&D people is capable of doing Contract or co-development with international
companies of repute.

ab scale batches for tablets, capsules, granules and liquids can be taken in this center before
validation batches are taken up in their respective units.

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Analytical Stability Indicating methods for all new products are also developed in this R&D
facility which are then transferred after partial / complete validation along with the complete
technical package to the respective units.

Stability studies for all the new products developed are carried out as per ICH guidelines;
Dissolution Profiles and Impurity Profiles are compared with the innovator.
More focus is on the development of value added products and Novel Drug Delivery System
(NDDS), especially of our API division molecules using Patent-Non infringing processes.

Achievements

Day 1 launch of Atorvastatin tablets in UK in May, 2012 after patent expiry in collaboration with
Wockhardt UK.

Filed about 1350 dossiers for registration in about 75 countries worldwide of the products
developed in-house.

Technology transfer done for about 100 products for site variance from Europe, Canada and
Australia to Global business unit of Ind-Swift Ltd.

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Manufacturing prowess

Ind-Swift operates six manufacturing plants dedicated to finished dosage forms and another three
to the production of active pharmaceutical ingredients.

The group's first company, Ind-Swift Ltd, is dedicated to the former. It runs plants at Jawaharpur
in Punjab(operated by GBU, it's exports arm), at Jammu (in Jammu & Kashmir), as well as two
facilities each at two distinct locations in Himachal Pradesh -- at Parwanoo (Units 1 & II) and at
Baddi (Units III & IV). Between them, they manufacture the complete array of finished dosage
forms; producing everything from tablets, capsules, soft gels and injectables, to ointments, dry
syrups, dry powder and granule filled sachets.

A company subsidiary, Ind-Swift Labs Ltd, is focused on producing active pharmaceutical

ingredients. Plants at Derabassi in Punjab, at Jammu in J&K, as well as a joint venture project in
Iran are operational.

4
Quality Assurance & Quality Control
Quality is the mainstay of our competitiveness.
At Ind-Swift, we take considerable focus in adherence to the QA policies. Our policies direct our
operation to constantly create an environment of quality and compliance in line with the best
recognized global practices.
Quality Assurance, though an independent function, works as an interface between R&D and
manufacturing strictly abiding with the standardized quality system, providing consistency,
effectiveness and efficiency for all manufacturing activities of formulation across all our
manufacturing locations.
Focused on:

 Establishing Quality Standards

 Training personnel
 Developing processes to achieve set standards
 Close Monitoring
 Consistency at every stage
It engages itself towards driving the quality philosophy of the organization and assuring that the
global standards of cGMP are implemented in form and spirit at every level and during each
process.
Our systems & policies bring effectiveness through periodic quality reviews, periodic audits,
review of compliance to regulatory inspections and customer audits.
Focuses on review of failures, rejections, market complaints, deviations, non-compliances,
product stability and various corrective & preventive actions planning.
Our endeavour is to constantly achieve QUALITY EXCELLENCE.

5
Products

We manufacture the complete array of finished dosage forms; producing everything from tablets,
capsules, soft gels and injectables, to ointments, dry syrups, dry powder and granule filled
sachets.

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Anti-Infectives (Macrolides)

Brand Active Substance Formulation Dosage Form Presentatio

n

Clarie OD/ Swift Clarithromycin 500 mg XR Tablets 10x1x7

OD Blisters

Claris 250 Clarithromycin 250 mg Tablets 10x2x7

Blisters

Claris DS 125 Clarithromycin 125 mg/5ml HDPE bottle

Claris DS 250 Granules for of 50ml
reconstitution

Claris DS 125 Clarithromycin 250 mg/5ml HDPE bottle

Claris DS 251 Granules for of 50ml
reconstitution

Clone DT Clarithrornycin 125mg Dispersible Tablets 5x1x10

Strips

Swazi 250 Azithromycin 250 mg Tablets 10x1x6

Blisters

Swazi 500 Azithromycin 500 mg Tablets 10x1x3

Blisters

Swoxy 150 Roxithromycin 150 mg Tablets 10x1x10

Blisters

Anti-Infectives (Fluoroquinolones)

Brand Active Substance Formulation Dosage Form Presentatio

n

Indpro 250 Ciprofloxacin 250 mg Tablets 10x1x10

Blisters

Indpro 500 Ciprofloxacin 500 mg Tablets 10x1x10

Blisters

Swoflox 100 Ofloxacin 100 mg Tablets 10x1x10

Blisters

Swoflox 200 Ofloxacin 200 mg Tablets 10x1x10

Blisters

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Cardiovasculars

Brand Active Substance Formulation Dosage Form Presentatio

n

Acerip 10 Ramipril 10 mg Tablets 3x10 Alu-

Alu

Acerip 2.5 Ramipril 2.5 mg Tablets 3x10 Alu-

Alu

Acerip 5 Ramipril 5 mg Tablets 3x10 Alu-

Alu

Atstat 10/ Atorvastatin 10 mg Tablets 3x10 Alu-

Atswift 10/ Qest Alu
10

Atstat 20/ Atorvastatin 20 mg Tablets 3x10 Alu-

Atswift 20/ Qest Alu
20

Atstat 40/ Atorvastatin 40 mg Tablets 3x10 Alu-

Atswift 40/ Qest Alu
40

Atstat 80/ Atorvastatin 80 mg Tablets 3x10 Alu-

Atswift 80/ Qest Alu
80

Atstat-AM Atorvastatin 10 mg + 5 mg Tablets 3x10 Alu-

+Amlodipine Alu

Atstat-EB Atorvastatin + 10 mg + 10 mg Tablets 3x10 Alu-

Ezetimibe Alu

Atstat-EB Atorvastatin + 20 mg + 10 mg Tablets 3x10 Alu-

Ezetimibe Alu

Candez 16 Candesartan 16 mg Tablets 3010 Blisters

Candez 4 Candesartan 4mg Tablets 3x10 Blisters

Candez 8 Candesartan 8 mg Tablets 3x10 Blisters

Caplor Clopidogrel 75 mg Tablets 3x10 Alu-

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 Alu

Caplor-AS Clopidogrel + 75 mg + 75 mg Tablets 3x10 Alu-

Aspirin Alu

Indol 100 Alenolol 100 mg Tablets 10x10

Blisters

Indol 50 Alenolol 50 mg Tablets 10x10

Blisters

Ivadin 5 Ivabradine 5 mg Tablets 3 x10

Blisters

Ivadinn 7.5 Ivabradine 7.5 mg Tablets 3 x10

Blisters

Staro 10 Rosuvastatin 10 mg Tablets 3x10 Alu-

Alu

Staro 20 Rosuvastatin 20 mg Tablets 3x10 Alu-

Alu

Staro 40 Rosuvastatin 40 rig Tablets 3x10 Alu-

Alu

Staro 5 Rosuvastatin 5 mg Tablets 3x10 Alu-

Alu

SwamJo-AT Amlodipine 5 mg + 50 mg 3x10 Strips

+Atenolol

Swarnlo 10 Amlodipine 10 mg Tablets 3x10 Strips

Swarnlo 5 Amlodipine 5 mg Tablets 3x10 Strips

Swilix 2.5 lndapamide 25 mg Tablets 3x10 Alu-

Alu

Swilix SR 1.5 lndapamide 1.5 mg SR Tablets 3x10 Alu-

Alu

Telmiswift 80 Telmisartan 80 mg Tablets 3x10 Alu-

Alu

Telmiswift H-40 Telmisartan + 40 mg + 12.5 mg Tablets 3x10 Alu-

Hydrochlorthi- Alu

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 azide

Telmiswift H-80 Telmisartan + 80 mg + 12.5 mg Tablets 3x10 Alu-

Hydrochlorthi- Alu
azide

Telrniswift 40 Telmisartan 40 mg Tablets 3x10 Alu-

Alu

RAW MATERIAL AND FINISHED GOODS SECTION

RAW MATERIALS
Araw material, also known as afeedstock or most correctlyunprocessed material, is a basic material
that is used to produce goods, finished products, energy, or intermediate materials which are
feedstock for future finished products. As feedstock, the term connotes these materials
are bottleneck assets and are highly important with regards to producing other
products. Pharmaceutical raw materials comprise substrates or elements that are used for
manufacturing different types of drugs e.g. endocrine disorder drugs, musculoskeletal system
drugs, anti-infective drugs viz.cephalexin, penicillin, ampicillin, cephradine, etc. Pharmaceutical
excipients and ingredients or raw materials used to manufacture drugs are extracted from
different types of sources. These sources could be natural or synthetic.
Pharmaceutical raw materials are essential to producing pharmaceutical drugs and include active
pharmaceutical ingredients (API), also known as bulk active, are pharmaceutically active ,and
have the desired pharmacological effects on the body e.g. alvimopan, sparfloxacin,
sapropterindihydrochloride, lanreotideacetate, nicotinic acid, etc. In contrast
pharmaceuticalexcipients are the pharmaceutically inert substances which help in delivering the
activeingredient, e.g. antiadherents, binders, coatings, disintegrants, fillers, etc

STEP INVOLVE IN RAW MATERIAL WAREHOUSE

 Receiving
 Sampling
 Storing
 Dispensing

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RECEIVING
 Raw material is supplied by vendors by placing order
 After receiving the raw material check the “observation onpack”
 Segregate the raw material according to batch number
 Pre entry cleaning of raw material by vacuum cleaner
 Weighing of the raw material

SAMPLING
 Before sampling get line clearance by QA person
 QC person test the sample of raw material under LAF by different tests and fill it
in“observation on sampling area&pack and certificate of analysis
 warehouse operators will paste the labels of “approved label “Sampled label
 next sent raw material for storing

STORING
 the raw material is stored at 3 different temperature zones
Ambient: not more than 35 °c
Controlled temperature room: 15 to 25 °c
Cold room: 2 to 8 °c
Temperature point:
It is the point where the temperature is checked by placing digital thermometer on daily basis .

DISPENSING
 Raw material is picked for dispensing according to “materialpicklist for process order
“and dispensed according to BMR prepared by QA personnel
 Selection of raw material is done accordingto “first expiryfirstdispense
 Raw material is dispensed from dispensing booth under LAF to the production area.

FINISHED GOODS
Finished goods are goods that have completed the manufacturing process but have not yet been
sold or distributed to the end user. A good purchased as a "raw material" goes into the
manufacture of a product. A good only partially completed during the manufacturing process is

11
called "work in process". When the good is completed as to manufacturing but not yet sold or
distributed to the end-user, it is called a "finished good". This is the last stage for the processing
of goods. The goods are ready to be consumed or distributed. There is no processing required in
term of the goods after this stage by the seller.

PROCEDURE
 Receive the finished good transfer ticket from production duly authorized by production
supervisor and checked by QA
 Following are to be made in finished good transfer ticket after received from production
 Name of product
 Batch No.
 Manufacturing date
 Expiry date
 Quantity (No of box x per pack)
 Date of transfer tickets
 Verify the received goods against transfer with above details
 Ensure the all details are complete as per out requirement
 In case of any observation, intimate to production department and get it corrected
 Enter the physically verified quantity in SAP system

PRODUCTION SECTION

GENERAL INSTRUCTIONS AND PRECAUTIONS

 Ensure area and equipment cleanliness before starting the manufacturing operations.
 Check and ensure that all manufacturing equipment and other required accessories
areclean ready for use.
 Wear gloves and nose mask during all manufacturing process.
 Counter check the weights of all ingredients before using in the batch
 Get line clearance from QA for manufacturing.

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  Air handling unit (AHU) system should be kept ON throughout the
manufacturing process.
 Temperature should be kept between 25ºC ±2ºC and relative humidity should be
kept between 50±10 %.
 Ensure that only QC approval purified water is being used for manufacturing purpose
 Always transfer solution to the manufacturing vessels through 20 meshes.
 During the preparation of this product, no other product processing should be done in
thesame area.
 Whenever sifting through SS mesh is involved; check the mesh integrity before and
afteruse.
 All critical aspects during manufacturing like temperature, duration of mixing,
weight,etc. must be checked and recorded by the supervisor.
 Supervisor to ensure completion of all in-process records during various stages
ofmanufacturing operations till completion of the batch.
 Release from QA should be taken from all in-process tests mentioned in
batchmanufacturing record
 No over writing is allowed in batch manufacturing record. If initial data is wrong
entered,cancel the data by single stroke arrow and put initials. Record reasons for change
as foot-note on the same page.
 All the details whatever is necessary should be recorded in batch manufacturing
record(BMR).
 Send a test request form to QC after manufacturing is completed
 Check all polyethylene bags before and after material loading for black particles
andsealing.
 Check calibration of respective equipment/machine before use.

TABLET COMPONENT AND ADDITIVES

ACTIVE INGREDIENTS
Aceclofenac, olmesartan, montelukast, loperamide, paracetamol, chlozoxazole, seratiopeptidase,
sesquihydrate AF, domperidone, pantoprazole, ranitidneetc

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NON-ACTIVE INGREDIENTS
 Diluents: starch, lactose, mannitol, sorbitol
 Binders: acacia, gelatin, Tragacanth, Calcium lactate trihydrate granular N.F,
Starch paste, polyvinyl pyrollidone, sodium alginate
 Lubricant: Stearic acid, Magnesium stearate, Calcium stearate and Talk.
 Disintegrates: Starches and most common disintegrantse.
 Colous: D&C and FD&C Dyes and lacquers.

GRANULATION
There are three methods of preparing Tablets. These are:
 Wet granulation
 Dry granulation (also called slugging)
 Direct compression
Each of these methods has its advantages and disadvantages. The first two step of millingand
mixing of the formulation are identical, but thereafter the processes differ, Eachindividual
operations of the process is known as unit operation.
STEP IN DIFFERENT METHODS OF MANUFACTURE

WET GRANULATION
 Mixing of drugs and excipients
 Mixing of milled powder
 Preperation of Binder solution
 Mixing of binder solution with powder mixture to form wet mass
 Coarse Screening of wet mass using 6-12 mesh
 Drying moist granules
 Screening dry granules with lubricant and disintegrants
 Mixing screened granules with lubricant and disintegrants
 Tablet compression

DRY GRANULATION
 Milling of drugs and excipients

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  Mixing of milled powders
 Compression into large, hard tablets called slugs
 Screening of slugs
 Mixing with lubricants and disintegrating agents
 Tablet compression

DIRECT COMPRESSION
 Milling of drugs and excipients
 Mixing of ingredients
 Mixing of ingredients

EQUIPMENTS
 Rapid Mixing Granulator (RMG)
 Steam Kettle
 Fluid Bed Dryer (FBD)
 Vibro Sifter with Loader
 Tippler and Co-Mill
 RimekCommuniting Mill
 Conta Blender
 Compressor

RAPID MIXING GRANULATOR (RMG)

RMG was developed for pharmaceutical and chemical industry. With the help of MRGwet
sifting is generally no longer necessary. After the mixing of dry components, wet
granulationoccurs (without transfer of dry mixture) producing loose granules in RMG. RMG is
specificallydesigned to meet the GMP requirements of the pharmaceutical industries.

FLUID BED DRYER (FBD)

In FBD, the fluidized air steam is introduced by a fan or a blower mounted at the top ofthe
apparatus. The air is heated to a required temperature in the air heater and flows upwardsthrough
the wet materials, which remains in a drying chamber fitted with a wire mesh supported at the

15
bottom. By this process, the material is suspended and agitated in a warm air steam whilethe
granulation is maintained in motion.

PACKAGING AND LABELLING

Packing is the technology of enclosing or protecting product for distribution, storage, sale,and
use. Packaging is also refers to the process of designing, evaluating, and producing packages.
Packaging can be described as a coordinated system of preparing goods
for transport,warehousing, logistics, sale, and end use. It is sometimes convenient to categorize
packages bylayer or functions.
 Primary Packaging
 Secondary Packaging
 Tertiary Packaging

PRIMARY PACKAGING:
Primary packaging is the material that first envelope the product andholds it. This usually is the
smallest unit of distribution or use and is the package which is indirect contact with the content.

SECONDARY PACKAGING:
Secondary packaging is outside the primary packing, and may beused to prevent pilferage or to
group primary packages together.

TERTIARY PACKING:
These are used for bulk handling, warehouse storage and transport shipping. The most common
form of palletized unit load that packs tightly into containers.

TYPES OF PACKAGING

1.Blister Packing

Thisis usefulfor packagingofunitdose ofpharmaceuticals. This packing mode has been used exten
sively good reasons. It is a packagingconfiguration capable of providing excellent environmental
protection, coupled with an aesthetically pleasing and efficacious appearance. It also provides

16
user functionally in terms of convenience, child resistance and now temperature resistance. The
blister package is formed by heat softening a sheet of thermoplastic resin and vacuum drawing
the softened sheets of plastic into a contoured mould. After coming, the sheet is released from
the mould and proceeds to the filling station of the packaging machine. The semi-rigid blister
previously formed, is filled with the product and
liddedwithaheatsealable backing material. The backing material can be either a push through or p
eelable type.For a push through type of blister, the backing material is usually heat seal coated
aluminum foil.

2.Strip Packing

The strip packing is done by aluminum foil or glassine poly paper. A strip package is formed by
feeding two webs of a heat sealable flexible film through either a heated crimping roller or a
heated reciprocating platen. The product is dropped into the pocket formed prior to forming the
final set of seals. continuous set of packets is formed, generally several packets wide depending
on the packaging machine’s limitations. The strip of packets is cut to the desired number of
packets in length. The strips formed are usually collected and packed into a folding carton.
Theproductsealed between the two sheets of film usually has a seal around each tablet, with perf
orations usually separating adjacent packets.

3.Alu-Alu packing

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PACKING MACHINERIES
 Accumulating and collating machine
 Blister packs, skin packs and vacuum packing machines

 Converting machine

 Filling machine

 Linear vibrator

 Coding, printing, marking, stamping and imprinting machine

 Package filling and closing machine

 Palletizing, depalletizing, unit load assembly

 Packing sealing machine

 Conveyor belts

 Label dispenser: Domino printer

 Weighing machine: check weigher

 Wrapping machine Carton machine .

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PROCESS VALIDATION:
“Process Validation is establishing documented evidence
which provides a high degree of assurance that a specific process will consistently
produce a productmeeting its pre-determined specificationsand quality characteristics.”

Types of process validation:

1) Prospective validation
2) Retrospective validation
3) Concurrent validation
4) Revalidation

Instruments and Devices seen in Microbiology Laboratory

 Analytical balance
 Incubator
 Refrigerator
 Biosafety cabinet / Laminar Air Flow
 Magnetic stirrer
 Deef freezer
 Light microscope
 PH meter
 Autoclave
 Hot air oven

Analytical Balance
They are used in precise weighing of small amounts (uptomiligrams) of samples and
chemicalsused for preparing media and stock solutions.

Biosafety Cabinet
It is used in microbial inoculation and isolation studies as well as sterile storage of materials.
Inaddition, it is utilized for protection of user, samples and the environment from
hazardouscontamination.

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Refrigerator
The device is used for the storage of the stock solutions, chemicals, kits and nutrient media
thatshould be maintained at certain temperatures.

Shaker Incubator
In the microbiology laboratories it is among the leading devices which are based on the
principleof shaking at different temperatures according to the purpose and the work load of the
laboratory.

It is used in cultivating, multiplying and in the characterization tests of microorganisms.

Thisdevice provides the heat necessary for the growth of microorganisms.

Deep Freezer
It is used to store stock cultures in microbiology. It is a device used to store materials
whichshould be kept at low temperatures (cells, tissues, enzymes, proteins, etc.)

Inverted Phase Contrast Light Microscope

Inverted Phase Contrast Light Micros By the help of different refractive properties of the
light,Phase Contrast Light Microscope provides visibility to subcellular structures of
microorganismsthat are examined in a liquid medium without any staining. Fluorescence
attachment is used todisplay objects stained with special fluorescent dyes (DAPI, FITC, Texas
Red Etc.) and thatcannot be displayed with normal light microscopy techniques. It
operates according to the principle of reflective light.

Magnetic Stirrer
Magnetic stirrer is a device which provides mixing and keeping the chemical solutions
andmixtures at a certain time and temperature by the help of a magnetic bar. Vortex agitates
thesolutions in the tube, flask and so on in certain speed and duration.

Incubator
In the microbiology laboratories it is among the leading devices which work at
differenttemperatures according to the purpose and the work load of the laboratory. It is used

20
incultivating, multiplying and in the characterization tests of microorganisms. This device
providesthe heat necessary for the growth of microorganisms.

PH meter
It is used to determine the pH of the media prior to experiments and to monitor pH value
duringexperiments. The device is used especially in the preparation of stock solutions and the
culturemedia used for the growth of microorganisms.

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 SUMMARY
During my training period, in the industry I acquired lots of experiences in Pharmaceutical
Production and Production management. This will help me to clarify my theoretical knowledge. I
hope and pray that it will help me much in my future profession.

During our training period, we had seen various instruments and apparatus in the industry. The
highly sophisticated instruments that work precisely must be operated with intense care for
optimum use. We could acquire a lot of information regarding the latest instruments and their
working procedures.

It was taught to us that, the CGMP guidelines are to be strictly followed in the industries in each
and every section. And the same guideline was seen followed Ind-Swift Limited Mohali. It
helped us to acquire knowledge on punctuality, regularity and working environments in
industries.

Training in Ind-Swift Limited my mind in different sectors based on education, communication

and interactions, zero determination of error, commercialization and many more.

22
 CONCLUSION

Industrial training is very much essential for Pharmacy Students. It is also a great opportunity to
acquire practical knowledge. During my training period, in the industry I acquired lots of
experiences in Pharmaceutical Production and Production management. This will help me to
clarify my theoretical knowledge. I hope and pray that it will help me much in my
future profession.

During our training period, we had seen various instruments and apparatus in the industry. The
highly sophisticated instruments that work precisely must be operated with intense care for
optimum use. We could acquire a lot of information regarding the latest instruments and their
working procedures.

It was taught to us that, the CGMP guidelines are to be strictly followed in the industries in each
and every section. And the same guideline was seen followed Ind-Swift Limited. It helped us to
acquire knowledge on punctuality, regularity and working environments in industries.

Training in Ind-Swift Limited Shape my mind in different sectors based on education,

communication and interactions, zero determination of error, commercialization and many more.

23