PROJECT REPORT ON ORGANIZATION STUDY FOR

ACKNOWLEDGEMENT
First and foremost, I thank the Lord Almighty for his perpetual blessings, which led to the successful completion of my project.

I take this opportunity to express my deep sense of gratitude to all those who have helped me throughout this organizational study. It gives me immense pleasure to acknowledge all those who have rendered encouragement and support for the successful completion of this work.

I would like to convey my sincere thanks for giving me proper directions and suggestions and make use of this opportunity to express my heartfelt gratitude to Mr Narendra D, (CEO) for providing me all the faculties for making my project a successful one.

I express my deep sense of gratitude to Prof. Dilipchandra S the faculty member of Christ University Institute of Management (CUIM) for encouraging and inspiring me for developing the project.

My project work involved many people at different stages. I would like to thank all those who have directly or indirectly contributed to the success of our project.

I also take the opportunity to express profound gratitude to my parents, family members and several people who have contributed for the successful completion of the project. It is my duty and pleasure to acknowledge them.

DECLARATION

I hereby declare that the project report entitled Organizational Study and functioning of Lyophilization Systems India Pvt. Ltd. is a record of bonafide research carried out by me under the guidance of Prof. Dilipchandra S, Christ University Institute of Management (CUIM), Bangalore and no part of it has been submitted for any other degree or diploma.

Place: Bangalore Date:

Bhagesh Kumar

PREFACE
Orga n izationa l Func tion ing is an imp ortan t factor fo r an y O rgan izat ion to ach ieve the de sired goa ls an d Ob jectives. This requ ires Co -o rd inat ion at a ll leve ls to s mo oth fu nction ing. Th is rep o rt a ims to un de rstand th e function ing of Lyop hiliza tion Systems India Pvt. Ltd . re lation to d iffe re nt depa rtments.

As a part of two yea r MBA prog ra m, I had to carry on a p ro jec t in an organ izat ion in o rder to u nderstan d the orga n ization stru c ture and their functions . This was a g reat op portunity to get the first ha nd info rmat ion and unde rstand the function ing of the v ario us departmen ts.

I did my Organ izat ion Stud y at Lyoph ilization Systems In dia Pvt. L td . It was a great learn ing expe rience a s it is qu ite necess ary for a ll the manage me nt s tude nts. The main purp ose of doing the organ iza tion study was to s tudy the various de part ments of the org an ization and un de rstand their basic functio ns, their pu rpos e, ac hie vements , co mp etitors and the mis sio n an d vis ion of th e co mpa n y and their p ro g res s toward s that.

All g ene ra l info rma t io n I get in course is all book kno wledge, on wh ic h I entire ly c annot dep end. It is very impo rtant to ob serv e the a ctua l wo rking of an o rgan izat ion and the o vera ll stru cture of an organizat ion . The actu al profes sio na lism can be s tudied on ly th rough expe rie nce.

CONTENT
Sr. No. 1.0 2.0 3.0 4.0 5.0 6.0 7.0 8.0 9.0 10.0 11.0 12.0 13.0 14.0 15.0 16.0 17.0 Topic Introduction Industry Profile Mission statement of the Organisation Global Presence Other Global Lyophilizer manufacturing companies About Lyophilizers Product Profile at lyophilisation system India Pvt. Ltd. Organisational Structure at lyophilisation system India Pvt. Ltd. Key result areas (KRA) of all user departments Organisation design factors and approach SWOT analysis of the organization Significant factors for Success Product promotional measures Career planning and promotion policy of the employees System followed for purchase of materials HRD measures (including welfare measures) Manpower planning Page No. 7 10 11 12 12 13 15 20 25 28 31 32 33 34 35 36 37

Sr. No. 18.0 19.0 20.0 21.0 22.0 23.0 24.0

Topic Performance appraisal system Financial highlights of the organisation Future plans for growth of the Organisation Market Potential and Size Abbreviations Website References

Page No. 38 39 40 41 42 42 42

1.0

INTRODUCTION:

1.1

CONCEPT OF ORGANIZATION:
Organization is the process of;

1.1.1 Identifying and grouping the work to be performed. 1.1.2 Defining and delegating responsibility and authority. 1.1.3 Establishing the relationship for the purpose of enabling people to work efficiency together in accomplishing objectives.

1.2

PRINCIPLES OF ORGANIZATION:

Principle means the theoretical basis on which something is built up. The theoretical basis is formulated from fundamental truth. Some of the important principles to be followed for developing round and efficient organizations are: Principle of unity of objective. Principle of specification. Principle of co-ordination. Principle of unity of command. Principle of span of control. Principle of exception. Principle of flexibility. Principle of simplicity. Principle of communication. Principle of efficiency.

1.3 REQUSITIES OF A GOOD ORGANISATION: The objective are to be clear, candid and well defined and the organization must have a capacity to achieve it. All activities therein must be implemented easily, effectively and properly coordinated. The communication system within the organization must be effective. The span of control at all level must be reasonable. There should be provisions for future expansion, whenever needed. All activities and functions should follow defined procedures. The organization must be such that it promotes the morality of employees. There should be a proper diversion of authority and responsibility.

1.4 IMPORTANCE OF AN ORGANIZATION: Significance of the organization in any institution may be discussed as below: (i) It ensures optimum use of human resources: It establishes persons with different interests skills, knowledge and viewpoints.

(ii) It stimulates creativity: A sound and well conceived organization structure is the source of creative thinking and initiation of new ideas.

(iii)Use of improved technology: A good organization provides for optimum use of technological improvements.

(iv)

Co-ordination in the enterprise: In a good organization, the different

departments perform their functions in a closely related manner.

(v)

Executive development: The pattern of an organization structure has

strong influence on the development of executives. 8

(vi)It ensures co-operation among workers: A good organization promotes mutual goodwill and co-operation among workers also.

1.5 SCOPE OF ORGANISATIONAL STUDY: The study focuses on the overall structure of the organization. In this study, the researcher analyzed the overall functioning of the firm and also the financial performance of the enterprise. A moderate attempt has been made to perform the SWOT analysis of the organization.

1.6 METHODOLOGY OF ORGANISATIONAL STUDY:

1. PRIMARY DATA: Primary data are collected from discussions with the Managerial head of the various departments. 2. SECONDARY DATA: Secondary data are obtained from the annual report, from the website and other concerned books.

1.7 LIMITATIONS OF ORGANISATIONAL STUDY: Difficulty in meeting with all the top level Officials/HODs. Certain areas are restricted, so a detailed study is not possible.

2.0 INDUSTRY PROFILE: LYOPHILIZATION SYSTEMS INDIA PVT. LTD.

Lyophilization Systems India Pvt. Ltd. is an US based multinational company that specializes in the manufacture of freeze drying /Lyophilizer equipment for the pharmaceutical, food and research industries.

Presently they have production facilities in four international locations; USA, Korea, India and Thailand.

The company was established in 2003 at Hyderabad in India and has its manufacturing site build up in 20000 square feet area at the industrial estate of Hyderabad having the capacity to manufacture laboratory scale as well as large scale lyophilizers or freeze dryers conforming to the international norms set by the national as well as international regulatory agencies.

At Lyophilization Systems, they have additional manufacturing and service facilities located in Korea, India & Thailand. All of these locations have complete assembly and service capabilities support them to provide superior global support. All the personnel are trained and supervised by US headquarters, thereby maintaining the quality & degree of workmanship.

The company has ISO 9001:2008 (International Organization for Standardization) Certification given by TUV-SUD. TUV-SUD creates increased safety and added economic value.

10

Their clients include some of the most well known names in the world, and they pride themselves in achieving virtually 100% customer satisfaction. The Indian List of Clients
include:

M/S Dr. Reddy's Laboratories Limited M/S Wockhardt Limited M/S Cipla Limited M/S Matrix Laboratories Limited M/S Natco Pharma Limited M/S Dishman Pharmaceuticals Limited M/S Emcure Pharmaceuticals Limited Various Research Institutions in India

3.0

MISSION STATEMENT:

The corporate objective is to supply high performance freeze dryers (lyophilizers) with latest designs, intuitive control systems, and the finest quality workmanship. They provide their product range at competitive market price that makes their units the best value available in the market. Their main objectives are: Offering customized & superior quality products. Our products showcase innovative designs, which are a unique blend of the tradition & modern technology. Continuous upgrade for quality of our products, adhering to the latest set international standards. To provide superior quality Freeze Dryers (Lyophilizers) as per the latest cGMP practices.

11

4.0

GLOBAL PRESENCE:

USA, INDIA, KOREA, THAILAND.

5.0 OTHER GLOBAL LYOPHILIZERS MANUFACTURING COMPANIES:

The key players dominating the global freeze-drying equipment market include Biopharma Process Systems Ltd, Freezedry Specialties, IMA Edwards Pharmaceutical Systems, Labconco Corp, Niro A/S, Serail Freeze Drying Systems, SP Industries, Thermo Fisher Scientific Inc, and USIFROID SA. Some of the manufacturers are listed below: Analis SA/NV (Belgium). Appropriate Technical Resources, Inc (USA). Biopharma Process Systems Ltd (UK). BOC Group Plc (UK). GEA Niro (UK). Electron Microscopy Sciences (USA). Firlabo (France). Freezedry Specialties, Inc (USA). FTS System, Inc (USA). Hull Company (USA). Lyophilization Systems (USA). 12

6.0

ABOUT LYOPHILIZERS:

Lyophilization dries a product from the frozen state under temperature controlled conditions, the refrigeration systems process capabilities and performance are critical to a successful commercial Lyophilization operation. Lyophilization (freeze-drying) is increasingly used to gently stabilize pharmaceutical and biopharmaceutical products, and intermediates. Its recent growth is being driven by the escalating global demand for aseptic packaging and preservation of parenteral drugs, as well as by the rise in the production of biologics, including protein-based therapeutics and vaccines. During Lyophilization, most of the solvent (e.g., water or alcohol) is removed from a product after it is frozen and placed under vacuum. The process actually consists of three separate, but interdependent steps: 1) Freezing, 2) Primary drying (ice sublimation), 3) Secondary drying (moisture desorption). During primary drying, more than 90% of the solvent changes directly from solid to vapor phase through sublimation. The residual solvent remains adsorbed on the product as moisture. Some of this remaining solvent is desorbed during secondary drying to attain a moisture level too low to permit biological growth or chemical reactions, while still preserving the activity and integrity of the freeze-dried product.

6.1 KEY COMPONENTS OF LYOPHILIZERS:

A typical lyophilizer, or freeze-dryer, has nine main components plus auxiliary systems to carry out the Lyophilization cycle: 1. A vacuum chamber contains the shelves and the formulation to be lyophilized. 2. Hollow shelves hold the formulation and control its temperature.

13

3. Heat transfer fluid circulates inside the hollow shelves to precisely communicate cooling or heating through the shelves to the product. 4. Product to be lyophilized is specially formulated and typically contains the active ingredient, a solvent system, and several stabilization agents. Lyophilization of this formulation takes place in specialized containers on the shelves. These containers may be vials with stoppers, ampules, syringes, orin the case of bulk lyophilization pans. 5. A condenser removes the sublimated and desorbed solvent from the vapor phase by condensing or freezing it to maintain adequate vacuum inside the freeze-dryer. The condenser can be internally located in the chamber, or may be a separate external unit communicating with the chamber through an isolation valve. Most production freeze-dryers have external condensers. The capacity of a condenser is given in kilograms or liters of ice that it can hold frozen on its cooled surface. 6. The mechanical or cryogenic refrigeration system provides refrigeration to the shelves and condenser (and sometimes the walls) of the freeze-dryer by cooling the heat transfer fluid or directly expanding a refrigerant in the space to be cooled. 7. Heater (typically electric) provides heat to the HTF to slowly sublimate the ice and desorb solvent from the frozen cake on the shelves. 8. The vacuum pump pulls vacuum in the chamber and condenser. 9. Control hardware and software systems direct various parts of the complex freezedrying equipment and carry out the preprogrammed Lyophilization cycle. The controller may also provide documentation, data logging, and security capabilities.

14

In the coming years, the market for lyophilized products is expected to grow with the increasing demand for injectable solutions and new biological product introductions. With advancements taking place, the Lyophilization process would include in-process monitoring, decreased cycle times, increased automation, and processing

enhancements.

There is a wide range of product for which Lyophilization is used as a conservation method such as: Antibiotics, Vaccines, Hormones, Vitamins, Enzymes, Peptides, Liposome, Collagens, Blood plasma, Monoclonal antibodies (mAbs), Liver extract, Plant extract.

7.0 PRODUCT PROFILE AT LYOPHILIZATION SYSTEMS INDIA PVT LTD:

The company manufactures four range or series of lyophilizers which are made on customers requirements. The details for each product are given below:

Quanta series
Lyomax series Lyodryer series Lyolab series 15

7.1 QUANTA SERIES: LSI offers pilot and production scale freeze dryers in seemingly unlimited configurations, to meet the widest range of applications and your most demanding needs. For pharmaceutical/biotech applications, all internal surfaces are constructed of 316L stainless steel and offer a polish of 20 Ra or better.

7.1.1 Innovation in the product: Cost savings: The chamber style between cylindrical and square with the floor space requirements to provide the best fit solution.

Engineering: All systems include a radiant heat plate above the top shelf for uniform drying on all shelves.

High reliability two- stage or screw compressors are use to cool the shelves and the condenser.

16

7.2 LYOMAX SERIES: A rectangular chamber offers a compact profile with either bulk or bottom-up hydraulic stoppering configuration. Both options have a radiant heat plate above the top shelf for uniform drying on all shelves. All internal surfaces are constructed of 316L stainless steel and offer a polish of 20 Ra or better.

7.2.1 Innovation in the product: A remote coil condenser is located between the product and the vacuum pump providing maximum condensing surface area and vacuum pump protection, with the ability to add an optional isolation valve.

The Lyomax series has a radiant heat plate above the top shelf for uniform drying on all shelves.

17

7.3 LYODRYER SERIES: A rectangular chamber offers a compact profile with either bulk or bottom-up hydraulic stoppering configuration. Both options have a radiant heat plate above the top shelf for uniform drying on all shelves. All internal surfaces are constructed of 316L stainless steel and offer a polish of 20 Ra or better.

7.3.1 Innovation in the product: Lyophilization Systems Research Series is a new generation laboratory research freeze dryer designed with the same parameters as industrial sized machines.

Fluid filled hollow shelves with a serpentine fluid path provide the most uniform shelf temperature possible, resulting in consistent and repeatable drying.

18

7.4 LYOLAB SERIES: A rectangular chamber offers a compact profile with either bulk or bottom-up hydraulic stoppering configuration. Both options have a radiant heat plate above the top shelf for uniform drying on all shelves. All internal surfaces are constructed of 316L stainless steel and offer a polish of 20 Ra or better.

7. 4.1 Innovation in the product: All units come with one product tray per shelf; either a removable bottom or bulk. Easy to use software provides automatic freeze-drying, defrost, system and leak rate testing. Data can be printed in either numerically or graphically.

19

Engineering and Safety Manager

8.0 ORGANISATIONAL STRUCTURE AT LYOPHILIZATION SYSTEMS INDIA PVT. LTD.:

Stores Manager

Technical and services Manager

Finance Manager

CEO (India)

Chairman (USA)

Marketing Manager

Human Resource Manager

Purchase Manager

Quality Manager

Production Manager

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8.1 PRODUCTION DEPARTMENT: Production department is the most important department of Lyophilization Systems India Pvt. Ltd. This department carries out the manufacturing of all the products. The company carries out continuous production. Hence, this department plays a very crucial role in Lyophilization Systems India Pvt. Ltd.

8.2 HUMAN RESOURCE DEPARTMENT: Human resource is considered as the most vital asset of an organization. It helps the organization to perform well in the market. Human resources department is headed by manager, HRD, who organizes the training programs for workers and managerial staff. The department is also responsible for framing promotion policy of the Organization.

The HRD organizes training programs using internal faulty or engaging faculties from reputed organizations. The department in consultation with concerned department heads to organize house training programs.

21

8.2.1

VARIOUS TRAINING PROGRAMMES: GENERAL TRAINING: In order to provide this type of training, one has to determine what would be the trainees growth potentials, up to what level he can grow in the organization etc. A performance appraisal has to be done to evaluate his present performance. Training is given on the basis of appraisal.

NEED BASED TRAINING: Need based training will be done o the basis of determining the level of knowledge and skill one requires for a particular job. Next is to find out how many employees have to be given this training. On the basis of these needs training is given to the employees.

CUSTOMER TRAINING: Customers are given training on handling of machines and other equipments in various situations.

INDUCTION TRAINING: It is the training provided to the newly recruited employees to familiarize with the activities, rules, policies of the organization. It is also done to introduce the new employees to the other employees of the organization.

22

TECHNOLOGY TRAINING Company provides advanced training for workers to cope up with the technological changes. Feed back is obtained from employees and the effectiveness of the training programme is ascertained after a period of 2-3 months.

PERSONALITY DEVELOPMENT PROGRAMES Personality development programmers are conducted in a regular time period for the development of both workers and manager.

8.3 FINANCE DEPARTMENT:

Lyophilization Systems India Pvt. Ltd has an efficient finance department headed by the finance manager Mr. Krishna. P. The finance manager is responsible for shaping the fortunes of the company, preparing budgets, raising funds, keeping different accounts etc. Lyophilization Systems India Pvt. Ltd is having management information system to assist the finance department. The finance department itself is divided into different sections like general accounts, costing bills, establishment and provident fund accounts sections each having its own functions. 23

8.4 TECHINCAL AND SERVICE DEPARTMENT: The technical and service department is concerned with technical aspects of the plant. The department is headed by Mr. Natrajan who ensures that the production plan does not face any technical issues. The department takes care of all the production reports and at the time of new technology innovation, provides support and service to production department.

8.5 ENGINEERING AND SAFETY DEPARTMENT: The Engineering and Safety department are responsible to provide technical support, installation and safety procedures followed in the company. The department is headed by Mr. Pillai who is responsible to ensure availability of utilities at the time of production.

8.6 QUALITY DEPARTMENT: The quality department is responsible to maintain the quality of the products at each stage of Productions. The Quality department is headed by Mr. Saha who has expertise in maintaining Quality in manufacturing unit. The Quality standard maintenance and ensuring the total Quality management are the main functions of the department.

8.7 STORES DEPARTMENT: The Stores department is responsible to maintain the inventory of the stock as well as storage of raw materials used during the production activity. The department is headed by Mr. Volvoikar who ensures that the principles of FIFO are maintained for the raw materials.

24

8.8 MARKETING DEPARTMENT: The marketing department is responsible for branding and selling of the finished products. The marketing department is headed by Mr. Shiv Prasad who is assisted by four sub ordinates who take care of targets set and at the same time make policies to attract new potential clients.

9.0

KEY RESULT AREAS OF ALL THE DEPARTMENTS:

Key result area refers to general areas of outcomes or outputs for which a role is responsible. Key result areas (KRAs) capture about 80% of a work rule. Identifying KRSs helps individual to: o Clarify their roles. o Align their roles to the organizations business or strategic plan. o Focus on result rather than activities. o Set goals and objectives. o Make value added decisions. o Prioritize their activities and therefore improve their time/work management.

9.1

KEY RESULT AREAS (KRAs) OF PRODUCTIONS DEPARTMENT: 1. To fix the monthly target according to the market Productions 2. Responsible for the modification of the production process and is responsible for efficient discharges. 3. To produce the finished product as per the customer requirement and reduce non confirming products. 4. Optimizing the specific consumption of electricity, raw materials and resources. 5. On time delivery of product at the customers site.

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9.2

KEY RESULT AREAS (KRAs) OF HUMAN RESOURCE DEPARTMENT: 1. To recruit talented employees in the organization. 2. To process payrolls as well as final settlement of the employees. 3. To set up Human Resource Policy of the Organization. 4. To organize trainings such as Induction training, on job trainings and other occasional trainings. 5. To set up Health care Policy for the employees such as ESI, Med claim etc.

9.3

KEY RESULT AREAS (KRAs)OF FINANCE DEPARTMENT:

1. To pass the Purchase bills and payment to suppliers. 2. To plan Budgeting and costing of all the user departments in the Organization. 3. To provide control related to Finance. 4. To Handle all auditing and taxes 5. To generate and utilize available funds.

9.4

KEY RESULT AREAS (KRAs)OF TECHINCAL AND SERVICE DEPARTMENT:

1. To collect daily data from plant control room to senior management. 2. To prepare monthly reports, both internal and external and maintaining reports of production loss due to various reasons. 3. Calculation of monthly production bonus. 4. To provide technical expertise to production department during any crisis.

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9.5

KEY

RESULT

AREAS

(KRAs)

OF

ENGINEERING

AND

SAFETY

DEPARTMENT:

1. To provide technical as well as safety support to Production. 2. To take care of Utilities such as power, water and compressed air during production activity. 3. To make employees aware regarding fire, safety and first aid.

4. To conduct safety mock drills in the Organization. 5. Regular maintenance of fire, water pumps and tanks. 6. To Issue of work permits to carry out various hot & cold jobs in the company.

9.6

KEY RESULT AREAS (KRAs) OF QUALITY DEPARTMENT:

1. To check the Quality of incoming raw material, in process fluid and finished goods. 2. Preparation of Qualification protocols such as Installation, Operational and Performance Qualification. 3. To take care of documentation in the organization such as Quality Policy, Standard Operating procedure (SOP), Site master file etc. 4. To implement vendor approval system for vendor evaluation and selection.

9.7 KEY RESULT AREAS (KRAs) OF STORES DEPARTMENT: 1. To maintain inventory of the raw materials and stock. 2. To store all the raw materials at their recommended storage conditions. 3. Issuance of raw materials for the production activity. 4. Dispatch of finished product from the company.

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9.8 KEY RESULT AREAS (KRAs) OF MARKETING DEPARTMENT: 1. To create branding value of the finished product. 2. To create new and maintaining the existing clients. 3. To explore the untouched avenues and markets. 4. Communicating customer requirement to the production team. 5. To set monthly targets and generate sales reports.

10.0 ORGANISATION DESIGN FACTOR AND APPROACH:

An organization structure determines the programs and procedures by which the administrative relations of an enterprise are defined and established. No activity of the organization can go out of this structure. As the policy of the enterprise determines the limits within which the enterprise has to work. In the same manner organization structure determines and defines the shape and size of the enterprise according to which the administrative and organization decisions have to be taken. It is also the framework of activities of the enterprise, it may also be considered as the map of the building to be constructed. Organization structure can be defined, as the organization structure of an organization deals with its organizational arrangements. 10.1 ADVANTAGES OF THE ORGANIZATION STRUCTURE:

The organization structure has the following advantages in the enterprise: Necessary for the management: - it is necessary for the management of the business and industrial enterprise. In the absence of a clearly defined organization structure, the management cannot discharge its duties properly because the structure defines and defines the relation between all the departments of the enterprise and the rights and duties of all the in the enterprise. It also tells us about the managerial approach. 28

It reveals the drawback of an organization: - organization structure is an important document of an enterprise. It serves as the guidelines to explain what should be done in the enterprise. Actual performance of the enterprise is compared with this document. The way it reveals the drawback of an organization

Helpful in delegation: - it is also helpful in providing the suitable training to the employees of the organization and defining their duties. It helps in delegating proper authority to the employees so that they can discharge their duties effectively and efficiently.

Helpful in training: - It is also helpful in providing suitable training to the employees and defining their duties like mentioned in the above. It defined the requirements of all the suitable postages and it also determines the need, nature, and the form of the training required.

10.2 DISADVANTAGES OF ORGANIZATION STRUCTURE:

The organization structure follows from the certain defects: It is difficult to change it: - Management is a dynamic science. To make is a real science, must be practical, no hard and fast line can be drawn in the activities of enterprise, organization structure is the definite determination of activities. Therefore, it develops rigidness in the activities and becomes difficult to make any changes easily. It reveals only the formal relations: - A very important drawback of the organization structure is that it is only a formal document. It defines only the formal relations among the employees of an enterprise. But in practice, there are two types of relations among them. Formal and informal and organization structure does not define informal relations.

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It creates conflicts: - Organization structure makes clear difference in the rights and duties of all the employees of the enterprise. It is the feeling of boss and subordinate among them. It also develops the feeling of superior and inferior. It also develops the feeling of senior and junior.

10.3 RECOMMENDATION TO OVERCOME THE DRAWBACK:

Job Responsibilities: Job descriptions of the employees to be update annually so that the some more challenging tasks delegated to the employee. The concept of Vertical Job enrichment needs to be advocated in the Organization.

Introduction of inter departmental meetings: Inter departmental meetings to be advocated so that the departmental strengths and weakness can be highlighted and at the same time avenues for further growth can be explored.

Daily meeting of all department Head: Daily meeting of all relevant department heads to discuss issues related to production activity. The meeting should be made mandatory for the department Heads to attend daily. Any unresolved issues can be brought in the notice of senior management.

Quality Management Review: Every Quarter, Quality management review meetings along with senior management should be done. During this meeting, production plan and goals can be framed and hurdles in their attainment should be discussed.

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11.0 SWOT ANALYSIS OF THE ORGANIZATION:

WEAKNESS: STRENGTHS: Low operational costs. On time delivery of the product on site. Presence of established distribution networks in both urban and rural Areas. Lower scope of investing in technology and achieving economies of scale, especially in small sectors. Low intellectual property. "Me-too products, which illegally mimic the established brands.

OPPORTUNITIES: Untapped Indian markets where new potential players are emerging. Rising profits i.e. increase in purchasing power of consumers. High export potential. THREATS: Big names already present in the market. Tax and regulatory structure

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12.0 SIGNIFICANT FACTORS FOR SUCCESS OF THE ORGANISATION:

Following are the significant factors contributing for the success:

On time delivery of the finished product supported with Quality documentation required by national as well international regulations.

Use of innovative technologies which ultimately lowers the manufacturing cost of the finished product.

Regular trainings of the employees in order to upgrade their knowledge base and contribute to the success of the organization.

Customer satisfaction due to in place Quality System.

Broad product range which suits the need of institutions to big pharmaceutical companies.

Daily reporting of the production activities in order to keep track of demand and supply.

Easy and affordable product maintenance.

Strong network of techno-commercial team.

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13.0 PRODUCT PROMOTIONAL MEASURES:

The company adopts innovative ways of promoting their products such as: Promotion of products through social networking sites such as Face book, Tweeter, Blogs etc.

Strong network of marketing team which are responsible for particular territory or areas which are responsible for promotion/exposure of the product.

Active participation in marketing conferences/ seminars such as CPJI, Mumbai where various companies participate and show case their capacity and promote their products to delegates attending from different

pharmaceutical/Bio-pharmaceutical Organization.

Regular donation of small scale / pilot scale lyophilizers to institutions for their research and at the same time branding of the product.

Member of IndiaMart

which helps the company to display

their product online to its potential customers. The customers can contact the company directly through the mart and enquire about their requirements with top management of the Organization.

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14.0 CAREER PLANING AND PROMOTION POLICY OF EMPLOYEES:

The Corporate Human Resource department along with the senior management frames policy related to career planning and promotion policy of the employees. Some of the policies are mentioned below:

The educationally as well as technical competent personnel are recruited to be part of the organization.

Proper Job responsibilities or description are prepared for individual employee in discussion with particular department Head and their technical expertise.

The management keeps a keen eye on the performance of particular employee and finds the areas of interest of particular employee so that external trainings can be arranged in order to build the intellectual base which shall contribute to the companys as well individual growth.

Yearly appraisal systems are present which are done for each and every employee so that proper and justified increment in salary as well as promotion can be given to the employee.

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15.0 SYSTEM FOLLOWED FOR PURCHASE OF MATERIALS:

The company has well defined Enterprise Resource Planning (ERP) system which is integrated Navision System which is Microsoft based ERP system. The Flow chart for purchase is given as below:

Start Indent from the user department through the system

Preparation of techno commercial comparison by the user department by different vendors

NO

Approval by the Chief Executive Officer (CEO)

YES Generation of Purchase Order (PO) by Purchase department and initiation of procurement of the particular item.

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16.0

HUMAN RESOURCE DEPARTMENT MEASURES (WELFARE MEASURES):

The Human Resource Department employs various measures which are aimed to promote welfare of its employees. Following events are organized:

Celebrating Birthdays of the entire employee working in the organization which helps to boost the morale of the employees.

Organizing annual company eve in which the employees are encourage to attend various cultural events and celebrate.

Recreational facilities after working hours such as Table Tennis, Badminton and Gymnasium.

Affordable Health care services launched by the government such as ESI as well as tie up with Life insurance firms to provide them accidental covers and at the same time employees as well as their dependents get benefitted by the scheme.

Various plans such as Pension, Bonuses and Gratuity to the employees in order to give financial benefits.

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17.0 MANPOWER PLANNING:

The manpower planning is based on the production demand. The Chief executive Officer, Production manager, Quality manager, Stores manager, Engineering manager and the Human Resource manager conduct a joint meeting to finalize the manpower requirements for particular production plan.

The working shifts for the employees are decided during the meeting. Generally, during prime production hours, three working shifts are planned viz. G1 Shift which starts from 7:00 am to 3:15 pm, G Shift which starts from 8:30 am to 5:00 pm and G2 Shift which starts from 3:00 pm to 11:15 pm.

The working hours for employees are 08 hours per shift but sometimes due to prime production hours, the working hours extend beyond 08 hours for which the particular employee is entitled for overtime.

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18.0 PERFORMANCE APPRAISAL SYSTEM:

A well defined annual performance appraisal system is present in the Organization. The performance appraisal is done for each employee usually at the end of a financial year.

The performance appraisal form is designed by the Human Resource department which is uploaded to the system in which the employees have to enter the required details pertaining to the major task performed by the employee as well as his/her contribution towards the growth of the organization in that particular financial year.

Every employee is appraised by his/her department Head or Manager, Plant Manager as well as the Human Resource Manager. The incremented salary gets credited to his salaried account as soon as the entire appraisal cycle is complete.

Apart from annual appraisal system, monthly and bimonthly appraisal system is also present in the organization. The fresher who joins the organization undergo monthly appraisal whereas the employee having substantial amount of experience are on Probation and the employees on Probation undergo bimonthly appraisal.

The appraisal system is designed to appreciate the hard work and contribution of the particular employee in terms of monetary gain or in other words increase in their salary by a certain percentage.

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19.0 FINANCIAL HIGHLIGHTS OF THE ORGANIZATION:

Since its inception in the year 2003 in India, Lyophilization Systems India Pvt Ltd is continuously branding itself in this highly growing market through Quality and innovation and at the same time attracting more clients per year.

Given below graph shows the financial highlights of the company for past three years.

Financial Highlights for Lyophilization Systems India Pvt. Ltd.

2014

2013

2012

2011
year

2010

2009

2008

2007 Annual Turn Over (US$ Million) Year

1 0.75 2009

2 1.5 2010

3 2 2011

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20.0 FUTURE PLANS FOR GROWTH OF THE ORGANISATION:

The company during their annual corporate meetings jointly discusses the requirements for the expansion of Organization as well as feedback received from the existing Clients.

To set up a full fledge Research and Development (R&D) in India so that they can cater the needs of the Asian continent requirements.

To set up manufacturing location in South Africa as the region is potential source of customers.

To include some more innovative lyophilizers models in the market that can cut down the energy as well as utility consumption drastically.

To enrich the existing intellectual capacity of the employees so that they can contribute effectively to the growth of the Organization.

To upgrade the existing qualification documentation system that complies with national as well as international regulations.

To strengthen its Service/Maintenance wing so that any emergency at the customer site can be attended promptly.

Induction of Lean principles in order to minimize waste and maximize profit.

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21.0 MARKET POTENTIAL AND SIZE:

The overall global market for Lyophilization equipment was estimated to be USD$1.8bn in 2010, and is predicted to reach USD$2.5bn in 2015.

The growth in this market is expected to come from an increase in the number of biotechnology drugs on the market as well as vaccines, both of which require rapid stabilization, long term shelf-life and end-user convenience.

According to industry experts, the corresponding increase in Lyophilization capacity has been fueling double-digit growth in global cGMP freeze-drying equipment sales, which have reached approximately $250 million per year. Asia-Pacific freeze drying equipment market holds significant potential in terms of revenues growth. Revenues from this region are projected to grow at 6.74% during the period 2011 through 2015. In the coming years, the market for lyophilized products is expected to grow with the increasing demand for injectable solutions and new biological product introductions. With advancements taking place, the lyophilization process would include in-process monitoring, decreased cycle times, increased automation, and processing enhancements. Pilot & industrial freeze drying equipment market in Europe and is projected to cross $780.51 million by the year 2015.

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22.0 ABBREVIATIONS:
Sr. No. 1.0 2.0 3.0 4.0 5.0 6.0 7.0 8.0 SOP HOD R&D KRA PO ERP Pvt. Ltd. Standard Operating Procedure Head of department Research and Development Key result area Purchase Order Enterprise resource planning Private Limited Term Abbreviation

23.0 WEBSITES:
1. www.google.com 2. www.lyogroup.in

24.0 REFERENCES:
1. Annual Product Review Report for 2009-10, 2010-11. 2. Site Master File of the Organization. 3. Organogram 4. Quality Policy 5. Freeze Drying Equipment: A Global Strategic Business Report, Global Industry Analysts Inc, 2008.

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