REETESH CHOURASIA Shri Ram Institute of Technology-Pharmacy

B.Pharma Jabalpur (M.P.) 482002 INDIA

DECLARATION

This is to certify that the dissertation work entitled “Industrial Training

Report.” for the award of “Bachelor o f Pharmacy” degree, comprises of the
bonafied research work carried out by me in our laboratories and library under the
supervision and guidance of Prof. D.P.Agrawal, (Principal), Shri Ram Institute of
Technology-Pharmacy, Jabalpur (M.P.).

I also declare that the present work embodied has not formed the basis for the
award of any other degree or fellowship previously. The particulars given in this
thesis are true to best of my knowledge.

REETESH CHOURASIA

SHRI RAM INSTITUTE OF TECHNOLOGY

 ( DEPT.OF PHARMACY)
Approved by: AICTE, PCI, New Delhi & Govt. of M.P.
(Affiliated To R.G.P.V.V.-University of Technology of Madhya Pradesh)
ISO 9001: 2000 Certified Institution
Near ITI, Madhotal, Jabalpur-482002 (M.P.) Tele: 0761-2640891,2649959
Fax:0761-2640294
Email:[email protected],Website:www.sritedu.org

DATE : / /2007 PALCE : JABALPUR

CERTIFICATE

This is to certify that REETESH CHOURASIA has submitted his

dissertation entitled " Industrial Training Report.", in partial fulfillment of

the requirement for the degree of Bachelor of Pharmacy, with his truly and

honestly observed inferences during the work. He has completed his project

under my supervision. His work is original, satisfactory and is not submitted

anywhere else for the award of any degree.

I hereby forward his dissertation.

Supervisor
Prof. D.P.Agrawal Principal.
Shri Ram Institute Of Technology-Pharmacy
Jabalpur (M.P.)
 ACKNOWLEDGEMENT

At this juncture, I would like to thank my mother for her affection and
perseverant, benevolence throughout my education and submit our sincere
thanks to our teachers who reformed me from my early days of education to
my graduation for mounding me as a professional men.

It is my great privilege, pride and honor in expressing my deepest sense

of gratitude to my esteemed inspiring, untiring mentor Prof.D.P.Agrawal,
(Principal), Shri Ram Institute of Technology-Pharmacy, Jabalpur (M.P.). in
presenting this thesis entitled “Industrial Training Report.” His constant
inspiration, memorable guidance, innovative ideas, instigation, at various
stages and above all her untiring valuable support has brought out this thesis
to an exquisite workmanship and great success.

Finally I consider this as an opportunity to express my gratitude to all the

dignitaries who have been involved directly or indirectly with the successful
completion of this dissertation.

REETESH CHOURASIA
 CONTENT

Declaration

Certificate

Acknowledgement

Chapter No. Title Page No.

1 Detail of Company Profile

Introduction
Mission
2 Raw Material Storage
3 Quality Control and Assurance Department
Quality Control
Quality Control and Quality Assurance
Organizatio
Analytical Control
Documentation
4 Tablet Department
Introduction
Equipment
5 Ointment Department
Introduction
Equipment
6 Liquid Department
Introduction
Equipment
7 Capsule Department
Introduction
Equipment
8 Safety Department
9 Packaging Material Store (PM Store)

11 Packaging
12 Conclusion
CompanyProfile

Ranbaxy Laboratories Limited (Ranbaxy), India's largest pharmaceutical company, is an

integrated, research based, international pharmaceutical company, producing a wide range of

quality, affordable generic medicines, trusted by healthcare professionals and patients across

geographies. Ranbaxy today has a presence in 23 of the top 25 pharmaceutical markets of the

world. The Company has a global footprint in 46 countries, world-class manufacturing facilities

in 7 countries and serves customers in over 125 countries. 

In June 2008, Ranbaxy entered into an alliance with one of the largest Japanese innovator

companies, Daiichi Sankyo Company Ltd., to create an innovator and generic pharmaceutical

powerhouse. The combined entity now ranks among the top 20 pharmaceutical companies,

globally. The transformational deal will place Ranbaxy in a higher growth trajectory and it will

emerge stronger in terms of its global reach and in its capabilities in drug development and

manufacturing. 

Mission&Vision 

Ranbaxy's mission is ‘To become a Research-based International Pharmaceutical Company’. The

Company is driven by its vision to ‘Achieve significant business in proprietary prescription

products by 2012 with a strong presence in developed markets’. 

Financials

Ranbaxy was incorporated in 1961 and went public in 1973. For the year 2010, the Company

recorded Global Sales of US $ 1868 Mn. The Company has a balanced mix of revenues from
emerging and developed markets that contribute 50% and 44% respectively. In 2009, North

America, the Company's largest market contributed sales of US $ 660 Mn, followed by Europe

garnering US $ 272 Mn and Asia clocking sales of US $ 468 Mn. 

Strategy

Ranbaxy is focused on increasing the momentum in the generics business in its key markets

through organic and inorganic growth routes. Growth is well spread across geographies with

focus on developed and emerging markets. It is the Company’s constant endeavour to provide a

wide basket of generic and innovator products, leveraging the unique Hybrid Business Model

with Daiichi Sankyo. The Company will also increasingly focus in high growth potential

segments like Vaccines and Biogenerics. These new areas will add significant depth to the

existing product pipeline.

R&D

Ranbaxy views its R&D capabilities as a vital component of its business strategy that will

provide a sustainable, long-term competitive advantage. The Company has a pool of over 1,200

R&D personnel engaged in path-breaking research. 

Ranbaxy is among the few Indian pharmaceutical companies in India to have started its research

program in the late 70's, in support of its global ambitions. A first-of-its-kind world class R&D

centre was commissioned in 1994. Today, the Company has multi-disciplinary R&D centers at

Gurgaon, in India, with dedicated facilities for generics research and innovative research. The

R&D environment reflects its commitment to be a leader in the generics space offering value

added formulations and development of NDA/ANDAs, based on its Novel Drug Delivery

System (NDDS) research capability. Ranbaxy’s first significant international success using the
NDDS technology platform came in September 1999, when the Company out-licensed its first

once-a-day formulation to a multinational company. 

In July 2010, Ranbaxy’s New Drug Discovery Research (NDDR) was transferred to Daiichi

Sankyo India Pharma Private Limited as part of the strategy to strengthen the global Research

and Development structure of the Daiichi Sankyo Group. While NDDR will now become an

integral part of Daiichi Sankyo Life Science Research Center in India, based in Gurgaon,

Ranbaxy will continue to independently develop and later commercialise the anti-malarial new

drug, Arterolane + PQP, which is currently in Phase III trials. Ranbaxy will also explore the

further development of late stage programs developed by NDDR in the last few years, including

the development programs in the GSK collaboration. Within Ranbaxy, R&D of Generics will

now get a sharper focus, as the Company is increasingly working on more complex and specialist

areas.
RAW MATERIAL STORAGE

Stores are defined as a suborganisation in any Pharmaceutical Company where Materials

obtained are held in abeyance till inspected, approved and stocked. A store should have a

standard specification of material and there must be a simple method of accounting the material.

There should be regular flow of material to various consumer departments. The condition of

storage should be proper and a properly designed store is needed.

The store should be preferably located on the ground floor close to manufacturing

department. Adequate storage facilities should he there so that the drugs, chemicals, biological

etc. do not get deteriorated by moisture or heat.

An ideal store should have two entrances, one for receiving the articles and other for

issue of materials. Generally racks are used for storage of material made of angled iron, having

partitions. Costly items are stored in closed bins. The height of racks depends upon the height of

ceiling and should be about 2/3rd the height.

Since large number of products are to be stored in the store, a definite location code is to

be followed in order to identify the product or material placed in structure. For this purpose

analysis is carried out after studying their inventory like:

 FSN - Fast moving, Slow moving, Non- moving.

 HML - Heavy, Medium, Light materials.

 According to the above mentioned categorization, fast moving materials are placed near the

issue exits while non-moving articles are placed far from the exits. Similarly heavy items are

placed at the bottom and light items on the top.

Testing of Raw Materials

The pharmaceutical company should have own oc testing laboratory to check whether the

raw materials comply with the official standard or not. Following are standard for purity and

potency mentioned in INDIAN PHARMACOPOEIA 1985/1996.

Usual Strength : The strength, of a dosage form in which arc drug is usually

marketed.

Description : It is meant for preliminary screening .It gives

the property of any article.

Order and Taste : Immediately after opening the sample it should, give no odour that

is odour less.

Solubility : The following table gives the meaning of

Solubility:-

Descriptive Term Approximate quantity of solvents by

volume for one part of solute by weight

Very soluble Less than 1 part.

Freely soluble From-1-10 parts

Soluble From 10-30 parts

Sparingly soluble From 30-100 parts

Slightly soluble From 100-1000 parts

Very Slightly soluble From1000-10000 parts

Insoluble or practically in soluble More than 10000 parts

Expression of strengths:-

%W/W : Weight of active substance (in gms.) per 100gm of

product.

%W/W : Weight of active substance (in gms.) per 100011. of

the product.

%W/W : Number of ml. of active substance in 100ml. of the

product.

Limit of Impurities :- Unit of measurement is parts/million (ppm)

Solvents:- If solvent name is not indicated it mean solution in water. Distilled water means

purified water prepared by distillation ~ and Alcohol means J.P. 95% V/V and Ethyl alcohol

means absolute alcohol I.P. grade.

Packaging Storage and Labelling :-

Containers -

 Light resistant container

  Well closed container

 Tightly closed container

 Single close container

 Multiple close container

Storage conditions -

Cold - 2 - 8 C

Cool - 8 - 25 C

RT - Temperature prevailing in working areas.

Warms - 30 - 40 C

Excessive heat - Above 40 C

ASSAYS -

Official procedures are given in LP.

Biological/ microbiological Assays Tests - As specified in LP.

ANALYTICAL METHODS -

 Gravimetric analysis

 Volumetric analysis

 Solvent extraction techniques

 Chromatography

 Polarography

 Flame photometry
 Flourometry

 Electrophoresis
QUALITY CONTROL AND QUALITY ASSURANCE

QUALITY CONTROL :

Quality control may be defined as an 'Respective system for co-ordination of the quality

maintenance and quality improvement efforts various group in an organization. So, level which

allowed full customer satisfaction 'while Quality is generally concerned with the best, quality

under set of condition Appraising conformance to these standard.

THE QUALITY CONTROL LABORATORY :

Quality control is probably the most common type of analytical laboratory. It serve

virtually every industry requiring analytical production support and is an environment to which

the space system is specially well suited. In Quality control environment safety, productivity,

reproducibility, accuracy and Education all are essential to success.

In addition to tool and technique described throughout this work, the quality. To

application of statistical quality control as a mean of providing information Of the manufactured

quality assurance groups and as a mean of controlling The laboratory cost of quality.

We at Amstrin and Elder are committed to ensure the highest quality of the Products.

Each product before reaching the consumer's undergoes rigorous Quality control tests, from the

raw material to on line checking and final Testing to finished packed products. This is

accomplishing by a team of well qualified and trained professionals packed by the most modern

sophisticated Instrumentation. The commitment to quality is enforced by our adherence to good

Manufacturing practices.
 One of the greatest strength of our quality control set up is the sophisticated

instrumentation use by our analysis and scientists. Some of major instruments arc detailed below:

 Lachrom HPLC System

 HPLC Pump Model 510 Waters

 HPLC V.V. Doctor Model 481 Waters

 HPLC Integrator model 745 Waters

 HPLC Gradient Controller Waters

 Spectrophotometer UV 150 02

 Photoflourimeter of Spectronic 20.

 Infra Red Spectrophotometer- LS.2B

 Gas Chromatograph Model Omega Q.C. Plus

 Photofluorimeter 151 Model

 Viscometer Digital

 Karl Fischer Automatic Titrator

 I R Moisture Balance

 PH Meter Digital

 PH Meter

 Refractometer

 Polarimeter

 Melting Point / Boiling Point Apparatus

 Disintegration Apparatus Tablet / Capsule

 Balance Single Pan

 Balances Two Pans

 Microscope

 Colony Counter Reader

 Autoclave

 Laminar Air Flow Cabinet Bench Type

 Centrifuge

 UV View Cabinet

 Muffle Furnace Digital

 Vaccum Oven Digital

 Vaccum Pump \/4 HP

 High Vaccum Pump Model VG

 TLC Assembly

 Antibiotic Zone Reader

 Platform Shaker

 Bursting Strength Apparatus

 Drying Oven

 Incubator Digital

 Water Baths

 Refrigerator
QULATIY CONTROL AND ASSURANCE ORGANIZATION

The quality of a product is its degree of possession of those characteristics Designed and

manufactured into it which contribute to the performance of an Intended function when the

product is used as directed.

Although the terms quality control and quality assurance are often used interchangeably

depending on the structure of specific company. There is a Counting tend to separate and define

their functional responsibilities.

Quality Control:-

It includes not only analytical testing of the finished products, but also the Assessment

for all operation beginning with receipt of raw material and Continuing throughout production

and packaging operation finished products Testing, documentation, surveillance and distribution.

Quality Assurance:-

It may be defined as the responsibility of an organization to determine that System

facilities and written procedure are both adequate and followed in order to assure that product are

control and will meet in the final dosage form, all the applicable specification.

Quality Control And Assurance Function:-

It normally consists of at least two primary units, analytical control and Inspection

control.

3. Analytical Control:-

The analytical control lab is responsible for testing and approving the raw Material work

in process and finished products. The lab must be staffed with Person who are trained both
academically and by experience to the perform Complex analysis to evaluate the acceptability of

the product, proper and more Sophisticated equipments are necessary for timely and accurate

analysis.

Detailed specification must also be available for the complete analysis. The testing and

appearance of only high quality raw material is essential in the preparation of product. This

should comply with Gimp's to a high degree.

Inspection Control:-

It include the sampling of incoming raw material, packaging and labeling components

4. Documentation:-

During the course of producing a, pharmaceutical product; numerous documents and

records are generated. All documentation related to specific code is referred to as a 'Batch

Record' which will include data on each significant case of Production control and distribution.

It only determines the Standard Operating Procedure (SOP) to assure the quality and

integrity of the product but also that these are current and being followed Sop's are reviewed

from time to time.

TABLET SECTION

INTRODUCTION:-

As per the Pharmacopoeia of India "Pharmaceutical tablets are solid, flat or biconvex discs,

prepared by compressing a drug or a mixture of drugs, with or without diluents. They vary in

shape and differ greatly in size and weight, depending on the amount of medicinal substances

and the intended mode of administration.

ADVANTAGES:-

 The accuracy of dosage.

 Complete admixture of ingredients.

 Rapid disintegration and dissolution.

 Ultimately the onset of drug action.

 Convenience and ease of handling.

TYPES OF TABLETS :-

 Sugar coated tablets (SCT)

 Film coated tablets (FCT)

 Enteric coated tablets (ECT)

 Chocolate coated tablets (CCT)

 Multiple compressed tablets (MCT)

 Buccal or Sublingual tablets

 Dispensing tablets (DT)

EQUIPMENTS IN TABLET DEPARTMENT

  Fluid Bed Drier 250 kgs

 Trey Driers 48 trays

 Planetary Mixer 500 Ltrs Capacity

 Planetary Mixer 50 Ltrs Capacity

 35 Stn Compression Machine

 37 Stn Compression Machine

 41 Stn Compression Machine

 45 Stn Compression Machine

 55 Stn Compression Machine

 6 Sugar Coating Pans

 6 Film Coating Pans with Coating Assembly

 Polishing Pans

 Steam Jacketed Paste Cattle

 Disintegration, Friability & Moisture Balance for IP, QC

 Tablet Counting Machine

 Fully Automatic Rocking Brio for Bottles

 Tin Container Sealing Machine

 Shrink Packing Machine

 Dehumidifier

Product – Top 10 Products (2009)

. Valacyclovir 

• Simvastatin
• Co-Amoxyclav

• Ciprofloxacin and Combinations

• Amoxycillin and Combinations

• Isotretinoin

• Ketorolac Tromethamine

• Loratadine and Combinations

• Ginseng+Vitamins

• Cephalexin

• Atorvastatin and Combinations

 FLUID BED DRYER

BLISTER PACKING MACHINE

OINTMENT SECTION

INTRODUCTION :-

Ointments are semi-solid preparation meant for external application to the skin or mucous

membrance. They usually contain a medicament or medicaments, dissolved suspended or

emulsified in are ointment base. They main contain a suitable antimicrobial preservative. The

ointments are mainly used as preservative or emollient for the skin.

Ointment Bases :-

The ointment base is that substance or part of an ointment, which series as carrier or

vehicle of the medicament. An ideal ointment base should possess the following properties :

 It should be inert, odourless and smooth

 It should be physically and chemically stable.

 It should be compatible to with the skin and with the incorporated medicaments.

 It should be of such a consistency that is spreads and softens when applied to the skin

with stress.

 It should not retard healing of the wound.

 It should not produce sensitization of the skin.

Classification Of Ointment Bases :-

 Oleaginous bases

 Absorption bases

 Emulsion bases

 Water soluble bases.

Preparation Of Ointments :-

Ointments which are semi-solid dosage form, while mixing such dosage forms. The material

must be brought to the agitator or the agitator must move the material through out mixer. The

mixing action includes combination of low speed, shear, smearing, wiping, folding, stretching

and compressing. A large amount of mechanical energy is applied to the material by moving

parts. Some times, apart of supplied energy appears as heat. The forces required for efficient

mixing an high consumption of power is also high. Hence, the equipment must be ruggedly

constructed to tolerate these forces.

Some semi solids exhibit dialatant property i.e viscosity increase with increase in shear rates.

Therefore must be done at lower speeds. The speed must be changed according to thixotropic,

plastic and psuedo plastic materials.

Ointments are formed by mixing oil phase and water phase by the help of a mixer, by

continous mixing till a perfect consistency of ointment is formed.

Oil Phase Mix with Water Phase Mix. In a mixing

Equipment ointment.

Most widely used mixing equipment is PLANETRY MIXER

OINTMENTS / CREAM/TOOTHPASTE MFG. PLANT

RIBBON BLENDER
EQUIPMENTS IN OINTMENTS SECTION

 S.S. manufacturing vessel of 500 kgs capacity

Oil phase

Water phase

Mixing phase

 S.S. storage tank 500 kgs capacity

 Automatic tube filling, giumping and coding machine

 Lamitube sealing and coding machine

 D.M. water plant 400 ltrs. Capacity

 Semi automatic washing, filling sealing and labeling Machine for lotion
LIQUID SECTION

INTRODUCTION :-

Liquid dosage forms meant either for internal, external or parenteral use may be sub-

classified into monophasic or biphasic liquid dosage Forms. The monophasic liquid dosage

forms consist of either true or colloidal solutions or solubilised system. All these consist of only

a single phase and may have either aqueous or non-aqueous solvent as the base. Biphasic dosage

forms represented by emulsions and suspensions and consist of two immiscible are phases, tile

continuous phase in and Dispersed phase. The continuous phase in this a liquid, the Dispersed

phase in emulsions is also a liquid while in i.e of Suspensions, the dispersed phase consist of a

finely divided solid.

ADVANTAGES :-

 The presentation of drugs as liquid dosage form offers the following advantages over

solid dosage form:

 The drugs is more readily available for absorption from liquid dosage forms as compared

to solid.

 The doses of drugs can be easily adjusted according to need of the patient.

 Liquids are easier to swallow than tablets or capsules and are therefore especially suitable

for children and the elderly.

 Gastric irritation due to certain drugs like KCL and KI when administered as a solids

dosage form is avoided or reduced on administration as a liquid dosage form.

 Drugs with large doses can be easily administered as liquid dosage form.

 Distribution of drug in liquid dosage forms is better than solid dosage form.

 Liquid dosage form arc more economical to produce than solid dosage form.
EQUIPMENTS IN LIQUID SECTION :-

 DM water plant -1200 Ltrs.

 Steam jacketed manufacturing tanks of 2000 Ltrs.

 SS storage tanks 2000 Ltrs.

 Collider mill.

 18 Inches filter press

 Emulsifier

 Fully Automatic 8 and 4 head P.P. cap sealing machine.

 Sealing machine cone

 Semi Automatic bottle washing machine

 Semi Automatic vaccum filling machine

 Semi Automatic pp cap sealing machine

 LIQUID/ORAL/SYRUP PROCESS PLANT

CAPSULE SECTION

HARD GELATIN CAPSULES SHELLS

Hard gelatin capsule shells are soluble containers for incorporation of drugs, usually in the form

of powder, pellets or granules, and are commonly intended for oral administration. The shells are

acted upon by digestive fluids and the filled contents are released. They are composed of gelatin,

water and additives such as plasticizers, humectants, surfactants, dispersing agents, flavouring

agents, antimicrobial agents, sweetening agents, opacifying agents and one or more coluring
agents permitted under the Drugs and Cosmetic Rule, 1945. Ingredients other than colouring

agents and opacifying agents comply with the standards of this Pharmacopoeia.

Category : Pharmaceutical aid.

Description : Hard Gelatin Capsule Shells (Shells or cases) consists of two cylindrical,

telescoping pieces (cap and body), one end of which is rounded and closed and the other open.

Shapes other than cylindrical can also be formed as per requirements. The two pieces are

uncoloured or coloured; if coloured, of identical or different colours; transparent or opaque,

partially or completely and printed or unprinted or bear other surface markings. The cap overlaps

the body and maintains a tight friction closure. The closure may be strengthened by suitable

means.

The shells are of various sizes, usually designated by different numbers, 5 being the

smallest and 000 the biggest. Shells of size 0 to 4 are commonly used. Shells of special shapes,

sizes, lengths and designations are also available. The shells are smooth and uniform in size,

shape and colour.

Equipments in Capsule Section

Hand Filling Capsule M/C Size “OO” to “3”

Dehumidifiers

Strip Packing Machine

Balances 150 gm Capacity

Split A/C

Conveyor Belt.
SAFETY DEPARTMENT

 Safety is the most important thing in industry.

 Pharmaceutical companies totally takes cares about safety.

 There are many slogans for safety also takes places as follows :-

"THERE IS NO HOLIDAY FOR SAFETY"

'A SAFETY RULE BREAKER, IS AN ACCIDENT MAKER'

"SAFETY IS EVERYBODIES BUISNESS"

 Safety department contains precaution mainly for accident.

 They also distribute aprons, globes, mask etc.

 For avoid hazards of acids or other chemicals PVC aprons are provided.

Gloves :-

 PVC gloves are provide for handling acidic and basic component. Lather or cotton gloves

provided for heat.

Shoes and booties :-

 PVC shoes are provided to protect legs from chemicals like acids.

 Booties are provided to protect the shoes from dust.

Helmets :-

 They are also provided to protect hair and head from chemicals and in case of accident.

Aprons :-

 They are provided for safety of body and cloths from acids and other chemicals.

 PVC or special cloths are provided.

Face shield and masks :-

 Face shield is provided to protect face and eyes from dusts and chemicals.

 Mask is provided to avoid the entrance of dust and bad smell in nose & mouth.
 PACKAGING MATERIAL STORE (PM STORE)

 Material should kept under special condition to avoid contamination in PM store.

 Because some materials are use for primary packaging.

FLOW DIAGRAM

Receiving

Under test (like printing, thickness, size etc.)

Approved Rejected back to

supplier

 Receiving

 It is the first step of PM store

 The checking of weight takes place randomly.

 Under test

 Sampling takes place in this step

 The samples are taken as per root n+1 ratio

 Where n = number of container.

 Approved

 The different tests are applied for approval

  Size of the material for major packaging.

 Rejected

 If material can't pass the about tests they are rejected.

 Keep under lock and key.

 Replace or back to supplier.

 Storage of particular plastic and primary packaging should at cool dry place.

 Because if it store in hot place the variation in size takes place.

 And printing may destroy though the melting procedure

 Rubber bands and another also keep in cool place.

PACKAGING

There are mainly two types of packing mentioned below :

1. Blister pack

2. Strip pack.

- The thickness of blister pack is less

- The packing only having alluminium foil

- The thickness of strip packing is more than blister This packing contains both

alluminium pack or plastic or paper foil also.

Flow Diagram: There are mainly four types

1) ALU- ALU STRIP (automatic).

Tablet setting on foil

Foiling with seal

Strip one by one

Checking only one foil through machine

Arrange on plate one by one

Insert in box (of strip & information paper)

folding of box

Close

Passed through inject printer