Job satisfaction @ elegant drug pvt ltd

Industry profile:

The pharmaceutical industry was buffeted by significant scientific, medical, political, and

market forces between 1960 and 1980. Approaches to drug discovery and early-stage

testing changed as medical advances made it possible to identify compounds that block

specific physiological processes

Pharmaceutical manufacturers have long operated on the boundary between, on the

one hand, acting as free-market inventors and sellers of drugs, and on the other,

serving the public interest by providing an essential health service. Thanks to this

unique market position, the industry has played a leading role in globalization,

developed innovative scientific advances in a wide range of medical fields, and

pioneered academic-industrial research collaborations.

Since 2001 the pharmaceuticals has grown rapidly into a $600million company which

employs almost 2,000 people offering a full range of pharmaceutical services to

Pharma, biotech and virtual organizations. They work in the fields of drug discovery,

research and development, patient diagnostics, clinical trials for new drugs, formulation

and packaging of drugs and the commercialization of pharmaceutical product. These

services have grown to the point where we now offer an unparalleled range of

pharmaceutical services on a global scale."

The Indian Pharmaceutical industry, valued at $46.2 billion has been witnessing

Attractive growth rate of 15% to 20% consistently over the past decade. (StrategistQuarterly 1998). This growth was build by India's large population, increasing allocation

of income to healthcare spending and exports. Exports which currently accounts for

20% of the production value has grown by a compound annual growth rate of 34% in

the past few years due to competitive price advantages from India's low labor and other

input cost

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The Indian market for pharmaceutical products stands at an enormous $58.8 billion.

The big 10 companies account for over 30% of that, take away 45 marketer and

average sales don't even come any where near the $2.5 million marks, that's how

fragmented its is some 50,000 brands from over 20,000 companies growing fast enough

to embraces rainy day

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Company profile

a) Brief information of the firm:

Name of the Firm: Elegant Drugs Pvt Ltd.

Established: 1992

Founder: Gautam Ostwal (C.E.O)

Type of Industry: S.S.I

Phone no: 0836-2252007, 235060

Source of Finance: Punjab National Bank

Products: Pharmaceuticals and Formulation

Address: R.S. NO. 59/3A,

Chalmatti - 581 204.

Dist: Dharwad

State: Karnataka

Office: Elegant Drugs Pvt Ltd

New Cotton Market

Hubli.

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Company Background:

Elegant Drugs Pvt Ltd was started in the year 1992 the company since have developed

more than 200 pharmaceutical formulations in form of tablets, capsules, oral liquids and

dry syrups.

As per revised Schedule M the manufacturing premises has been renovated and

constructed in month December 2005 and completed in first week of February 2006.

Dedicated manufacturing sections for Beta-lactum group of products have been

developed and all the facilities are provided as per norms of revised Schedule M.

The manufacturing facility of General sections i.e., Tablets, Capsules, and Liquid Orals

and the manufacturing facility for Beta-lactum group of products i.e. For Tablets,

Capsules, and Dry Syrups are segregated and developed as per revised norms of

Schedule M.

The firm has a plot area approx, up to 89,418.73 sq ft. out of which approx 8,000.00 sq

ft. is built up area & about 81,418.73 sq ft is left as surrounding area, for road and

garden and equipped with technically sophisticated facilities as per WHO norms to

manufacture complete range of Pharmaceutical formulations of Tablets, Capsules,

Liquids, Orals both in General & Beta-lactum Departments

Elegant Drugs Pvt. Ltd. managed with efficient and experienced man power with

installed manufacturing capacity of:

17.28 Crores of Tablets

8.64 Crores of Capsules

34.56 Lakhs Liters of Liquids

14 Lakhs Bottles of Orals

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Nature of business:

Elegant enjoys the reputation of being the registered Supplier of Drugs & Medicines to

most of the renowned Central, State and Semi-Government Institutions and Hospitals of

our country.

Elegant lays great emphasis on timely delivery of drugs within given time frames.

Safeguarding the competitive interests of customers with the highest professional

integrity has built up a partnership of trust to satisfy the needs of customers, they are

working to enhance and strengthen the research capabilities as well as to expand their

manufacturing facilities.

Vision:

The company has an aim to reach the optimum level in the field of manufacturing and

marketing quality pharmaceutical formulations. The management endeavors in future to

expand to global markets.

Quality policy:

We at Elegant Drugs Pvt Ltd aim to provide satisfaction our customers in domestic and

export market, by fully meeting their requirements in terms of quality, cost and delivery.

We will create a company, committed to quality by bringing about involvement of all

employees at all levels, for continual improvement in quality.

Single unique product:

Product refers to unique product like single cartoon of Brand-X medicine. Eg: the

paracetmol tablet manufactured by elegant as Brand name ELEMOL base this brand is

registered with elegant. So nobody else in India can manufacture this product.

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Batch Numbers:

For each and every production manufacturing pharmaceuticals production batch no is

assigned by production department. It will be in serial no and assigned as per SOP. As

each and every batch is analyzed by quality control department .The control number or

analytical number will be issued by quality department along with certificate of analysis

and release order

Size and color:

Color of tablet will be as per the product approvals or permission received from drugs

control department.

Size: If tablet in house specification Eg: 8mm diameter tablet, 10mm diameter tablet,

12.5mm diameter tablet, elongated tablet etc.

Size and colour of capsule is choice of manufacturer Eg: 00size of capsule, Size and

colour of capsule is choice of manufacturer Eg: 00size of capsule, Zero capsule, size 1,

2, 3 etc

Brand Name:

A Brand is the name, term, symbol, sign, design, or a combination of them, intended to

Identify the good or services of one seller or group of seller and to differentiate them

from those of competitors.

Generic:

Generic products are the products manufactured on the generic name. Generic name is

the chemical of the materials

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Types of products manufactured by the company

1. Antibiotics

2. Antidiarrhoels

3. Antibacterial

4. Antiemetic

5. Analgesics

6. Antiulcer

7. Sedative

8. Anti Inflammatory

9. Antidiabetic

10.Vitamin

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List of domestic and exports products:

Tablets Capsules Syrups/Dry Syrups

1 Acarbose Tablets 50 mg

2 Acarbose Tablets 100 mg

3 Atorvastatin Tablets 10 mg

4 Albendazole Tablets 400 mg

5 Riboflavine Tablets 5 mg

6 Salbutamol & Bromhexine

Tablets

7 B complex with Vit C Tablets

8 Ambroxol Hydrochloride

Tablets

15 mg

9 Ambroxol Hydrochloride

Tablets 30 mg

10 Citalopram Tablets 10 mg



13 Chlorpheniramine Maleate

Tablets 4 mg

14 Clarithromycin Tabets USP

500 mg

1 Celecoxib Capsules 100 mg

2 Celecoxib Capsules 200 mg

3 Ampicillin & Cloxacillin

Capsules

4 Tramadol

HydrochlorideCapsules

100 mg

5 Tramadol Hydrochloride

Capsules 150 mg

6 Tramadol Hydrochloride

Capsules 200 mg

7 Piroxicam Capsules 20 mg

8 Cloxacillin Capsules 20 mg

9 B Complex Forte with

Vitamin C Capsules

10 Haemetenic Capsules

11 Cefadroxil Capsules 500

mg

12 Ampicillin Capsules 250

mg

13 Ampicillin Capsules 500

1 Albendazole Suspension

2 Salbutamol & Bromhexine

Syrup

3 Cefixime for Oral

Suspension

4 Anticold Suspension

5 Trimethoprim &

Sulphamethoxazole

Suspension

6 Cough Syrup

7 Cough Expectorant

8 Ofloxacin Suspension

9 Cefadroxil Suspension

10 Ampicillin for Oral

Suspension

11 Roxthiromycin

Suspension

12 Amoxycillin for Oral

Suspension

13 Amoxycillin &

Clavulanate for Oral

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15 Clopidogrel Tablets 75 mg

16 Paracetamol & CPM Tablet

17 Amlodepine Tablets 2.5 mg

18 Amlodepine Tablets 5 mg

19 Amlodepine Tablets 7.5 mg

20 Amlodepine Tablets 10 mg

21 Tinidazole Tablets 500 mg

22 Carvidelol Tablets 3.125 mg

23 Carvidelol Tablets 6.25 mg

24 Sulphadiazine Tablets 500 mg

25 Sulphadimidine Tablets 500

mg

26 Glibenclamide Tablets 5 mg

27 Glibenclamide Tablets 10 mg

28 Nalidixic Acid Tablets 500 mg

29 Ibuprofen & Paracetamol

Tablets

30 Ciprofloxacin Tablets 250 mg

31 Ciprofloxacin Tablets 500 mg

32 Ciprofloxacin & Tinidazole

Tablets

33 Cisapride Tablets 10 mg

34 Cetirizine Hydrochloride

Tablets 10 mg

35 Anticold Tablets

36 Anticold Plus Tablets

37 Trimethoprim &

Sulphamethoxazole Tablets SS

38 Trimethoprim &

Sulphamethoxazole Tablets DS

mg

14 Amoxycillin Capsules 250

mg

15 Amoxycillin Capsules 500

mg

16 Amoxycillin & Cloxacillin

Capsules

17 Amoxycillin, Cloxacillin

and Lactic Acid Bacillus

Capsules

18 Omeprazole Capsules 20

mg

19 Omeprazole &

Domperidone Capsules

20 Cephalexin Capsules 250

mg

21 Cephalexin Capsules 500

mg

22 Rifampicin Capsules 450

mg

23 Ramipril Capsules 2.5 mg

24 Ramipril Capsules 5 mg

Suspension

14 Amoxycillin &

Clavulanate for Oral

Suspension

15 Erythromycin Oral

Suspension

16 Metronidazole &

Furazolidone

Suspension

17 Azithromycin

Suspension

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39 Trimethoprim &

Sulphamethoxazole Tablets Kid

40 Doxycycline Tablets 100 mg

41 Aspirin & Paracetamol

Tablets

42 B Complex with Vit C Tablets

43 Ofloxacin Tablets 100 mg



46 Diclofenac Tablets 50 mg

47 Diclofenac & Paracetamol

Tablets

48 Fluconazole Tablets 50 mg




52 Cefadroxil Dispersible Tablets

125 mg

53 Cefadroxil Dispersible

Tablets 250 mg

54 Ketoconazole Tablets 200 mg

55 Ampicillin Dispersible

Tablets 125 mg

56 Paracetamol Tablets 500 mg

57 Paracetamol Tablets 650 mg

58 Aluminium Hydroxide

Tablets 500 mg

59 Roxithromycin Tablets 150 mg

60 Roxithromycin Tablets 50 mg

61 Cefixime Tablets USP 100 mg

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62 Cefixime Tablets USP 200 mg

63 Mebendazole Tablets 100 mg

64 Metformine Tablets 500 mg

65 Ethambutol Hcl Tablets 400

mg

66 Ethambutol Hcl Tablets 800

mg

67 Amoxycillin & Clavulanate

Tablets

68 Amoxycillin Dispersible

Tablets 125 mg

69 Amoxycillin Dispersible

Tablets 250 mg

70 Atenolol Tablets 50 mg

71 Atenolol Tablets 100 mg

72 Norfloxacin Tablets 200 mg



74 Norfloxacin & Tinidazole

Tablets 75 Norfloxacin &

Metronidazole Tablets

76 Cephalexin Dispersible

Tablets 125 mg


Tablets 250 mg


Tablets 500 mg

77 Serratiopeptidase Tablets 5

mg

78 Serratiopeptidase Tablets

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10 mg

79 Serratiopeptidase Tablets

20 mg

80 Erythromycin Tablets 250 mg

81 Sparfloxacin Tablets 100 mg

82 Sparfloxacin Tablets 200 mg

83 Fexofenadine Tablets 120 mg

84 Fexofenadine Tablets 180 mg

85 Cefuroxime Tablets 250 mg

86 Cefuroxime Tablets 500 mg

87 Pioglitazone Tablets 15 mg

88 Pioglitazone Tablets 30 mg

89 Glimepiride Tablets 1 mg




93 Granisetron Tablets 1 mg

94 Granisetron Tablets 2 mg

95 Enalapril Maleate Tablets 2.5

mg 96 Enalapril Maleate Tablets

5 mg

97 Loratidine Tablets 10 mg

98 Levofloxacin Tablets 250 mg

99 Levofloxacin Tablets 500 mg

100 Losartan Potassium Tablets

25 mg

101 Losartan Potassium Tablets

50 mg

102 Mefloquine Tablets 250 mg

103 Meloxicam Tablets 7.5 mg

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104 Meloxicam Tablets 15 mg

105 Imipramine Tablets 50 mg

106 Imipramine Tablets 200 mg

107 Mosapride Citrate Tablets

2.5 mg

108 Mosapride Citrate Tablets 5

mg 109 Nifedipine Tablets 10 mg

110 Nimesulide Dispersible

Tablets 50 mg

111 Nimesulide Tablets 50 mg

112 Nimesulide Dispersible

Tablets 100 mg

113 Nimesulide Tablets 100 mg

114 Nimesulide & Paracetamol

Tablets

115 Gatifloxacin Tablets 200 mg

116 Gatifloxacin Tablets 400 mg

117 Olanzapine Tablets 2.5 mg

118 Olanzapine Tablets 5 mg

119 Olanzapine Tablets 10 mg

120 Pantoprazole Tablets 20 mg

121 Pantoprazole Tablets 40 mg

122 Calcium with Vit D3

Tablets 500

123 Calcium with Vit D3 Tablets

625

124 Theophylline Tablets 400 mg

125 Theophylline Tablets 600 mg

126 Esomeprazole Tablets 20 mg

127 Esomeprazole Tablets 40 mg

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128 Ornidazole Tablets 500 mg

129 Rabeprazole Sodium Tablets

15 mg

130 Rabeprazole Sodium Tablets

30 mg

131 Isosorbide Mononitrate

Tablets 20 mg

132 Isosorbide Mononitrate

Tablets 40 mg

133 Rosiglitazone Tablets 2 mg



136 Salbutamol Tablets 2 mg

137 Salbutamol Tablets 4 mg

138 Salbutamol & Theophylline

Tablets

139 Secnidazole Tablets 500 mg

140 Secnidazole Tablets 1000

mg 141 Simvastatin Tablets 10

mg

142 Simvastatin Tablets 20 mg

143 Artesunate Tablets 50 mg

144 Ticlopidine Hcl Tablets 250

mg 145 Ranitidine Tablets 150

mg

146 Ranitidine Tablets 300 mg

147 Gliclazide Tablets 40 mg

148 Gliclazide Tablets 80 mg

149 Gliclazide & Metformine

Tablets

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Fast moving products:

Tablet:

Capsule:

EDOXY-100

Each hard gelatin capsule contains

Doxycycline Hydrochloride I.P

Equivalent to Doxycycline 100mg

EMOX-500

Each capsule contains

Amoxycylline Trihydrate I.P

Equivalent to Amoxycillin 500mg

Dry Syrups:

EMOX DRY SYRUP

For oral suspension

Each 5ml of reconstituted

Suspense contains

Amphicillin trihydrate I.P

ELECILLIAN DRY SYRUP

For Oral Suspension I.P

Each 5ml of reconstituted

Suspense contains

Amphicillin trihydrate I.P

Equivalent to ampicillin 125mg

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CONSOLE-ED-2.5

Each uncoated tablet contains

Amoldipine Besylate BP

Equivalent to Amoldipine 5mg

ECOLD

Each uncoated tablet contains

Chlorpheniramine Maleate I.P 4mg

Caffeine(Anhydrous) I.P5mg

Phenylephrine Hydrocholoride I.P

5mg paracetamol I.P 400mg

Equivalent to ampicillin 125mg

Each 5ml contains

Paracetamol I.P 125mg

Area of operation:

The elegant drugs supply the products to local areas, government hospitals, and private

hospitals. It has also expanded its services to the other countries like Cambodia,

Myanmar, Vietnam & Nigeria.

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List of top authorities:

Elegant Drugs Pvt Ltd. is expertise by experienced technocrats.

Mr. Gautam S. Oswal : CHIEF EXECUTIVE OFFICER

Mr. Bharat B.Oswal : CHAIRMAN

Mr. Rajashekhar C. Pattanshetty: MANAGING DIRECTOR

Mr. Ramesh B. Oswal: FINANCE MANAGER

Mr. Vinod P. Oswal: PURCHASE MANAGER

Mr. Jeetendra .M. Oswal: MARKETING EXECUTIVE

Mr. Arun G. Pawar: PLANT MANAGER

Mr. S. B. Takked: QUALITY CONTROL MANAGER

Mr. Abdul S. Guthal : PRODUCTION EXECUTIVE

Mr. Karuna Vijay: PRODUCTION CHEMIST

Mr. Vishwanth S. Chinnadakai: STORES INCHARGE

Mr. Kumbar : STORES ASSISTANT

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Quality management:

The total management is quality conscious and has formed quality policies keeping in a

mind the constructive effect of quality products which pays permanent growth of the

business in the long run.

This proves the fact that….

1. Quality assurance is active & efficient

2. Production department is operated by highly trained experienced and qualified

technocrats.

3. General Manager visits the unit frequently to solve the problems if any and visualizes

the quality aspects by taking personal rounds of all the departments.

He also takes into account for requirement of space for the development and new

construction also comes into existence as and when required with his efforts. He

assesses the capacity of unit and suggests the management for the addition of new

products.

4. Production department, quality control department, Administration department. And

stores department work with team spirit to achieve desired goal of production Quality

and quantity.

5. Products are designed and developed in such a way that it takes account of CGMP

and to obey good stability.

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6. Production and quality control operations are clearly specified in written form.

7. Departmental heads are well aware of their responsibilities which are clarified in

systems and procedures (Job description column).

8. a. Raw materials are analyzed as per pharmacopoeias as well as in house standards.

b. Bulk sample analysis is carried out by Q. C. during the processing stages.

c. In process control is carried out by Q. C. as well as by production dept separately

d. Calibration and validation is carried out by production department with the

Help of Q. C. and maintenance staff.

e. The finished products are correctly processed and checked by production and Q. C.

according to the defined procedures and specifications.

f. After the certification by Q. C. and production authorities, the product is released for

dispatch.

g. There is a procedure of self inspection and quality audit once in six months which

regularly appraises the effectiveness and applicability of quality assurance system.

9. All manufacturing procedures are clearly defined and systematically reviewed.

10. Critical steps of manufacturing processes are supervised by production and Q. C

Head

11. All necessary facilities are provided in production which includes,

a) Qualified and trained personnel

b) Adequate space.

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c) Suitable equipments.

d) Correct materials and packaging.

e) Approved procedures and instructions

f) Suitable storage.

g) Adequate personnel

12. Instructions and procedures are described in clear and simple language.

13. Operators are trained to carry out process correctly.

14. Stage wise records are maintained.

15. Manufacturing records can trace history of the batch.

16. Complaints from market are examined and defects are investigated with appropriate

measures if required, including recalls of materials

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CUSTOMER PROFILE OF Elegant Drugs:

Domestic customer:

Government medical stores State and central government institutions like railway

hospitals, state government etc. Distribution of products through doctors that is

marketing as progangda come distribution.

Export market

Combida Canopus combida Ltd

Vietnam Canopus

Nigeria

Myanmar

Sri Lanka

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Future Growth and Prospectus:

Globalization, more exports and collaboration with foreign countries to

improve overall turnover facilities.

More investment in RND, RND formulation and labs.

Focus on talent acquisition, motivation, reward management and retention.

Strong growth is expected in domestic market.

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Organization structure

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Director C.E.O Finance manager

Manufacturing unit

Purchase

Factory Manager

QC Manager

Managing director

RESPONSIBILITIES AND AUTHORITIES OF KEY PERSONNEL:

C.E.O.

To formulate future strategic plan & policy decisions.

To chair meetings relating to the future policies

Participate in finalization of the budget for all activities

To nominate MR & authorized contract

M.D

Is responsible for implementation of QSM

Ensure complete understanding of quality policy & quality objectives in the whole

organization

Is in charge of complete maintenance and housekeeping of the factory

Organize work force when necessary

Is responsible for meeting complete Health policy requirements of the workers

Participates with FM and QC manger training programmed for the workers

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Stores Maintenance Production shift chemist

Is to conduct self inspection audits in the factory with the management team at

regular intervals

Maintains stores & stock registers

Verify the Purchase Request and received items as per Purchase Order

To initiate purchase when the stocks finished

To initiate the sundry purchase requirements

Supervise the quality system

PLANT MANAGER

Supervises the quality system

Allocates responsibilities and authorities to group needs

To review meetings with group heads and MR of QSM periodically

Coordinate with the departments for smooth functioning of Group as a whole

Make the employees turnover reports and appraise the higher authority

Participate in product design process activities

Manage time, Resources and schedule within the manufacturing unit

To plan for weekly production plans & to be submitted to chairman on every

Monday

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To arrange for daily production report to the chairman

Responsible for all activities carried out in production dept

To issue all requisition for raw materials

To ensure all operations running strictly as per master card

To ensure stores & stocks of materials for day to day production

To maintain all records as per drug and excise rules & regulations

To report for achievements and deviation regularly as per requirement

Initiate to conduct interviews for the requirement of new candidates.

Conducts management reviews of the quality system

To develop the policy guidelines for the employees

Motivate the relation between the management and the employees by bringing

the popular policies Finalization of loans & advance salaries to the factory

employees

Purchase/Marketing Manager

1 Take decisions on matters relating to contracts & agreements with the clients

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2 Interact with client as and when necessary

3 Review Proposals & Contracts

4 Provide resources during the progress of contract

5 Is to conduct self inspection audits in the factory along with the management

team every quarterly

6Contributes in analyzing customer complaints and assists in resolving them

7Invites quotations from vendors

Q.C Manager

Coordinates all quality related activities in the Organization

Is responsible for monitoring of all products raw material, in process and finished

Goods stage.

Is also responsible for signing all release notes irrespective of analysis by

internal or external lab.

Conducts analysis on products at all stages and record it

Ensure adherence to Master cards (Quality plans)

Ensure usage of laboratory practices

It responsible for calibration of all equipments in the laboratory

Has sole authority to release or reject raw materials and finished products

Is responsible for preservation of samples of all products and their records as per

the drug rules

Maintains library of all external referral document for analysis

To arrange for routine Q.C. activities

To authorize written procedures and documents of Q.C

To approve and monitor analysis carried out in-house

To check and calibrate all the equipments in Q.C.

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Shift Chemist

Is responsible for all production activities

Is responsible for getting raw material issued from the stores

Is then to coordinate issue of batch no for the particular batch

Inspects cleaning of machines and initiates production process

Records all activities in the batch manufacturing record

Is all responsible for calibration of all measuring equipment in production area

Notes down in process testing of products in BMR and is present there while the

testing is carried out

Ensure healthy work environment & discipline amongst workers

Reports of any deviations or abnormalities to the Factory manger.

Assistant Shift Chemist

Is responsible for all production activities

Inspects cleaning of machines and initiates production process

Records all activities in the batch manufacturing record book

Ensure adherence to the Production plan Master cards and any other product

Notes down in process testing of products in BMR and is present there while the

testing is carried out.

Ensure healthy work environment & discipline amongst workers

Assign task to workers

Supervises workers at all times

Reports status to FM.

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QC Assistant

Conducts analysis on products at all stages and record it

Ensures adherence to Master cards (quality plans)

Ensures usage of good laboratory practices

Ensures that equipment is calibrated before usage

Responsible for maintenance upkeep, and housekeeping of the lab.

Maintenance Operator

Ensures upkeep of all equipment

Maintains all equipment as per the maintenance plan

Ensures no breakdown results in loss of production

Maintains critical spares of machine

Stores Keeper (BSR)

Ensures only products with a release note are stored in BSR

Maintains inventory and stocks of BSR

On receipt of orders verbal or written from the marketing manager organizes all

excise, sales and other related documents

Ensure products are duly packed before dispatch

Follows FIFO and ensure no expired product leaves BSR

Also is responsible to maintain products at required room condition.

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Departmentalization:

PRODUCTION DEPARTMENT

Drug manufacturing for overseas markets is a highly competitive field and only the very

best can survive. It takes a strong infrastructure with a great deal of manufacturing

expertise to bring out the finest quality finished formulations. We have a long track

record of manufacturing pharmaceutical dosage forms for worldwide pharmaceutical

markets and we are proud to be able to provide high quality products that can improve

the health and quality of life of many people across the India at reasonable prices

We have a very good manufacturing infrastructure consisting of modern GMP Certified

facilities. We use state-of-the-art equipment and have a team of qualified professionals

who ensure that every product that rolls out of our factory will meet WHO and other

world class standards. This allows us to bring out the finest quality finished formulations

to cater to your every need.

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Flow chart of tablet preparation

Weighing Sieving Mixing and paste making Granulation

Tablet compress QA2 Lubrication QA1 Dry sizing Drying

QA3

QA4

Tablet checking Coating and polishing Coated . Tablet checking

Tablet striping

QA5

Tablet packing

Final release

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Coating solution preparation

QA1: Water content, QA2: Bulk assay, Bulk density, weight variations appearance,

colour and shape, QA3: Hardness, Physical parameters, Assay, Friability identification

Manufacturing process of capsule and packing

Stage1:

Dispensing of raw materials as per requirement of batch using B.MR. It consists of

ingredients like the main drugs, Excepients, Hard Gelatin Capsule Shells size as per

mentioned in the B.M.R.

STAGE 2:

Sieving of all ingredients (Raw Materials).

STAGE 3:

Mixing of all sieved ingredients as per specification given in the batch manufacturing

record.

STAGE 4:

Mixed sample will be collected by Q.C dept for analysis.

STAGE 5: Capsule Filling:

Setting of capsule filling machine for the requirement size of capsule.

The empty capsule is put in loading machine and the capsule is separated by the

plate (cap and bottom) by rotating the plate for twice/thrice.

Machine can take 5-6kg of powder, after that the capsule will be filled and cap is

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installed by the automatic machine, after that the capsule are weighed.

The weight of capsule should be for 20 capsules it must be 6.30gm-6.50gm, if

weigh is less than this it will be rejected.

STAGE 5: Capsule Wiping:

All filled capsule will handed over to capsule wiping dept, there

capsule inspection and wiping will be done with capsule wiping

machine.

Samples will be collected by Q.C dept for analysis (80-100 capsules

from each batch).

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STAGE 5: Capsule Blister Packing:

After the release of Q.C dept available polished capsule will be issued for

blister packing.

Blister packing of capsule will be done by blister packing machine

simultaneously secondary packing will be carried out on the conveyor Belt.

All the packed cartoons will be packed in a shipper as per the requirement

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Flowchart of capsule preparation

Weighing Sieving lubrication QA1 Filling

QA2

Capsule packing Capsule inspection and wiping

QA3

Final product release

QA1: Bulk density, water content

QA2: Complete testing as per STD procedure, QA3: Assay detection of

pathogen, dissolution.

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Manufacturing process of liquid orals :

Dissolve the preservative separately and add sugar syrup.

Add the solution of sweetening agent like sibtole, glycerine etc.

Add buffering agent if needed.

Add flavour’s and colours and mix for required time set up the volume and mix for

fixed time according to master formula.

Filter the product with help of filter platter

Collect the liquid for testing then connect the storage tank to the filling machine.

Set up the volume of syringe required to fill per bottle.

Start filling and put the pp cap then seal.

Take the bottle for visual inspection fitted with black and white tiles.

Discard the rejected bottle and send selected bottle for labeling cartooning and final

packing.

Flow chart of liquid orals

Weighing Preparation of sugar syrup mixing

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QA1

Checking Volume making Filtration

QA2

Labeling QA3 Packing Transfer to BSR Distribution

QA1: Ph check, Clarity if necessary.

QA2: Bulk analysis

QA3: Pack finishes analysis

QUALITY CONTROL DEPARTMENT

We believe it's a challenge to be a manufacturer of finished pharmaceutical

formulations. In our quest for perfection, we have left no stone unturned right from the

selection of the finest raw material, using state-of-the-art technology and processes to

bringing out the finished formulations. Helping us produce the finest quality

pharmaceutical products.

All our products are manufactured as per the regulations and guidelines of the World

Health Organization's Good Manufacturing Practice (WHO - GMP). We implement

this through our quality management system that is based on planning, implementation

and control with independent controls that guarantee safety and reliability ensuring that

only the finest quality pharmaceutical products rollout of our facility.

Our credentials include an ISO 9001: 2000 certification from the Orion Registrar USA

who is internationally accredited by the United States ANSI-RAB NAP, the Standards

Council of Canada (SCC), and the Dutch Council for Accreditation (RvA). Each of these

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national accreditation bodies are recognized throughout the world for Quality and

Environmental Programs. This establishes firmly that we are manufacturer of finished

pharmaceutical formulations of high quality.

The above initiatives are backed by an independent unit that analysis evaluates and

reports the status of quality control and quality assurance. They give accurate and

accountable results that help us produce the finest quality pharmaceutical products

always.

In a nutshell, the factors that have made us successful in drug manufacturing for

overseas markets are:

High quality products

Flexible responsive service

On-time delivery

Competitive pricing.

Excellent compliance record

Efficient technical transfers

Modern GMP Certified facilities

FDA approved site

Regulatory support.

Efficient inventory coverage

Organization of quality control department consists of Q.C managers, chemist, and

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executive lab assistants.

Marketing Department

A marketing program in order to be successful must have a right mixture of marketing

Mix, not to mention market research, a quality product, an extensive distribution

network. Acceptability, strong dose of promotion coupled with a right price. A unique

feature of the Pharmaceutical market is that it is one of the most fragmented markets in

the country.

Marketing Strategy of Company

Their core marketing strategy is to supply to government institutions.

The state government gives tender notice (Ad’s) in newspaper.

The Elegant Drugs are going to apply for tender (Open tender) through quotation

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(rate contract).

If the price bided by Elegant Drugs is lower than others they will get the contract.

and Usually this contract will be for 2-3 years

They have even appointed distributors in states who distribute product on behalf

of Elegant Drugs; the distributor promotes the product ethically.

The company also distributes the product through contact with doctors, and

through the mails for other countries distributors.

The company also participates in tenders of other states like Andrapradesh,

Rajasthan, and Punjab etc.

They also have sales agency called noble Health care which is run by the one of

their family member, who distributes the product in local areas.

Packing Department

Pharmaceutical products are typically susceptible to the damaging effects of moisture.

As such, it is imperative to use the right pharmaceutical packaging products, whether

they are being transported or simply stored. The company does not go for the packing

of products until Q.C and Q.A department releases the finished products. Packing and

marking are most important stages with regard to recognition of company’s product. As

their will be label entached to the shippers, which consists of name and address of the

company, name of the product , batch no, manufacturing date, expiry date, with brand

name and generic name

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Application of 7’s

SKILL

The skill refers to capabilities and competencies that exist within the company.

What it does best, distinctive competences – what the company does best, ways of

expanding or shifting competences. A skill captures a company’s crucial attributes or

capabilities.

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Company’s each divisions having ISO 9002 certificate and it has adopted

excellent quality policies and all modern safety and security measures all the levels. All

the manufacturing process is computerized and latest facilities and technologies.

The organization provides both on the job and off the job training for its staff

officers, technical assistance for every month. There will be 2 to 3 speakers , who

speaks regarding good manufacturing practices, technical aspects for technical

people .The trainee is been tested for every month by issuing question papers of 100

marks , the different questions papers are formulated for different level employees.

After setting the question it is been circulated to employees and then evaluation is

carried out.

STYLE

The leadership approach of top management and the organization’s overall

operating approach; also the way in which the organization’s employees present

themselves to the outside world, to suppliers and customers.

Style is pattern of actions that are more decisive than words. People may listen

to what managers say, but they believe what managers do. The appropriate style is

participative, allowing people to collaborative and supports each other, take calculated

risk and innovative improvements. It will not work for the management to say that it is

the organization’s policy

To encourage participation and innovation, if at the same time they also punish those

who make mistakes.

The management style of functioning is PARTICIPATIVE production unit, Elegant

Drugs. Any issue of significance is discussed with members of management

representatives and workmen to find an amicable solution. Besides these, any policy

implementation is done after threadbare discussion among various groups of

employees. In case of any confusion, reservation stroke of any issues, matter is referred

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to corporate office for guidelines.

STRATEGY

Actions, a company plans in response to or anticipation of changes in its external

environment. The Strategies of the company are developed on the basis of an analysis

of external and internal environment. Consequently the values, preferences, attitude

towards risks have been carefully examined while formulating strategies.

Business strategy is the choice of direction and the action and the company

adopts to achieve its objectives. It integrates the vision and direction of the company so

as to achieve its objectives and goals in a competitive situation

The company is having a long term objective to develop the entire spectrum of

manufacturing of tablets , capsule, dry syrup and syrup and the strategies also

includes exporting the products and services to several countries in the world and

provide qualitative products and services.

Finance Department

The company is having good personnel with plenty of knowledge & experience in

finance department. The finance consists of Chief of Accounts, Asst. Accountant &

Accountant. The finance department performs its activities as per the instructions of

Director Finance & Chief of Accounts.

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SOURCES OF FUNDS

Since funds can be obtained from different sources therefore their procurement is

always considered as a complex problem by business concerns. Funds procured from

different sources have different characteristics in terms of risk, cost and control.

SHARE CAPITAL

Funds raised by issue of shares are the best source of procurement of funds from the

point of view of the company. Because the company will not going to face any problem

of repayment of share capital until & unless the company is under liquidation.

However, equity share capital is usually the most expensive source of funds. This is

because the dividend expectations of shareholders are normally higher than prevalent

interest rate and also because dividends are an appropriation of profit and are not

allowed as expense under the Income Tax Act.

M/s. Elegant Drugs Pvt. Ltd. is a small scale industry. The company raised funds of Rs.

20, 00,000/- by issue of 2000 fully paid Equity shares of Rs.1, 000/- each.

DEBENTURES

Procurement of funds by issue of Debentures is comparatively cheaper since the

interest is paid out of profits before tax. However debentures entail a high degree of risk

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as they have to be repaid as per the terms of agreement and interest payment have to

be made whether or not the company makes profits.

M/s. Elegant Drugs Pvt. Ltd. is not having any funds procured in the form of debentures

as the same are to be repaid on expiry of lock in period or validity of debentures

Terms & Conditions of Term Loan for purchase of Machineries:

1. Estimations of Machineries:

Before applying for term loan for the purchase of machineries an estimation is to

be attached with the loan application form.

2. Quotations from different suppliers:

Quotations are to be collected from different vendors or suppliers for proposed

machinery purchases. Quotations collected from various vendors or suppliers are to be

submitted to the bank along with application for term loan.

3. Performa Invoice of machineries:

Performa Invoices are to be collected from different suppliers or vendors for

proposed machinery purchase. Performa Invoices collected from various suppliers or

vendors are to be submitted to the bank along with application for term loan.

4. Rate of Interest:

The rate of interest will be 13% to 14% p.a.

5. Margin Money:

To avail the term loan facility for the purchase of machineries certain percentage

of margin money is to be paid by the borrower. Presently 25% of cost of the machinery

is to be paid as margin money by the borrower.

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6. Board Resolution:

Public & private limited companies has to pass an resolution in board meeting by

the board of directors & the copy of the board resolution is to be submitted to the bank.

7. Agreement under Bond:

The company has to execute a agreement under bond for the purpose of term

loans.

8. Processing & Documentation Charges:

The bank will charge certain percentage of term loan amount as processing &

documentation charges for purchase of proposed machineries.

9. Disbursement of Term Loan:

After completion of the entire formalities bank will sanction the amount of loan for

purchase of machineries on the basis of estimation, quotations & Performa invoices.

The term loan sanctioned is going to be disbursed to the concerned vendor or supplier

as per the Performa invoices directly by way of demand drafts. If the company has not

paid the margin money earlier & the same is debited to the company’s bank account.

10. Registration of Charges:

The term loan is normally provided against hypothecation machineries in the

name of bank. The machineries so hypothecated are to be registered under the

Companies Act. with the registrar of companies. After registration of charges under the

Companies Act., a copy of registration is to be submitted to the bank.

Before signing the agreement of term loan the proposal is going to be verified by

the management of the company. It is the responsibility of the finance manager to

explain the implications on the company activities to the management.

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INTRODUCTION OF THE STUDY

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Need for the study

The objective of this project is to co-ordinate the theoretical aspect learnt in the

curriculum with the practical situation. This summer internship programme has

given the much needed exposure for the study to the real organizational culture.

In MBA course, the student study theoretical aspects of major functional areas of

an organization and in summer internship programme the students need to

observe the application of these theories in the organization.

This study covers the Labor welfare measures of Elegant Drugs Pvt Ltd.

Scope of the study

The scope of the project study was initially limited to the staff of the Elegant

Drugs Pvt Ltd. During the course of project it was felt necessary to include labors

of the company and was further limited to them only as they were the main

source behind our study. As the plant working conditions are to be studied, the

workers of the company were selected, it was further found and decided that the

labors should only be highlighted and targeted to get the required information.

Objectives of the study

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To analyze whether the labors are provided and furnished with the primary

requisites so they are satisfied in the organization.

To assess whether the labors are catered with the statutory and non

statutory allowances. Defined by the company.

To examine the level of job satisfaction.

Sources of methodology

Type of data

In this study, primary as well as secondary data collection methods are used.

Sources of data

The primaries such as questionnaires are used to get the required

information. The labors of the Elegant Drugs Pvt Ltd are been directly

contacted and the required information is sought by interviewing them

personally i.e., structured questionnaires are used to get the core matter of

the study.

The data related to company profile, financially indices and other quantitative

information is collected by the way of secondary data collection method i.e.,

through the website and other previous document of the HR and

administrative department.

Method of extent of selection of small (source) of data

The source of primary data is selected on the basis of sample. Minimum of

50 labors have been contacted personally & the information is sought out..

Techniques of data collection

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The primary data is collected by canvassing the structured questionnaires to the labors

of the company.

System of Presentation & Data Analysis

The so for collected primary data is presented in a tabular form with the help of graphs

the descriptive analysis is made.

RESEARCH ON LABOUR WELFARE MEASURES

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Introduction

Land, labor, capital &organization are the factors of production among which. Labor

occupies a pivotal place in the Economic Development of a Nation. To utilize the labor

force to the maximum level, certain welfare measures are needed. Various welfare

measures are in practice &new measures spring up quite often. Government & other

agencies are advocating & striving for new measures in these days. Studies related to

labor welfare are important in bringing about their right& privileges, of employees in the

organization.

Definition of Labor Welfare Measures:

The oxford dictionary defines Labor Welfare Measures as “Efforts to make worth living

for workers.” The report of the committee on Labor Welfare in 1969, defined Labor

Welfare as such services, facilities &amenities as, “Adequate canteen, rest &recreation,

sanitary & medical facilities, arrangement of travel to & from work & for the

accommodation of the workers employed at a distance from their homes &such other

services, amenities & facilities including social measures, so as to contribute an

improvement in the condition under which workers are employed.”

Classification of labor welfare measures

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The welfare measure may be classified along two basis, viz., Financial or Non

financial. Here are presented the two classifications of welfare measures.

Financial Non-Financial

0. Bonus1. Gratuity2. House rent allowances3. Medical allowances4. Local traveling allowances5. Scholarship for awards 6. Education allowances7. Group insurance8. Festival advance9. Meritorious service award10.Pension benefit

1. Canteen2. Shelter, lunch room3. First-aid service4. Welfare officers5. Leave benefit6. Suggestion box schemes7. Sports and Games8. Safety Committee9. Vehicle shed10.Drinking water11.Library12.Auditorium

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Bibliography :

1. K. Aswathappa, Human Resource Management

2. Company documents

3. old project report

4.website. www.elegantdrugs.com

5.Business research methods, zigmund.

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Index

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S. No. Contents 1 CHAPTER 1

INTRODUCTION OF THE STUDY

NEED FOR THE STUDY

OBJECTIVES

SOURCES OF THE DATA

LIMITATIONS OF THE STUDY

2 CHAPTER 2 COMPANY PROFILE PRODUCTS PROFILE. ORGANIZATION CHART DEPARTMENTALIZATION CUSTOMER PROFILE MISSION STATEMENT

3CHAPTER 3 STUDY PROFILE

RESEARCH ON LABOUR WELFARE MEASURES4 CHAPTER 4

PRESENTATION AND ANALYSES OF DATA TABULATED DATA GRAPHICAL REPRESENTATION

5 CHAPTER 5 WINDING UP

FINDINGS SUGGESTIONS CONCLUSIONS BIBLIOGRAPHY

Findings

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1. It was found that most of the workers are not having primary education in the

organization.

2. Most of the workers who are educated are studied up to 12 & further they

have completed ITI course.

3. It was found that company is providing all necessary facilities

& good working conditions to workers

4. All most all the workers of the company are satisfied.

5. There is a good cooperation & cohesiveness within the workers & there is a

good relation between the top management & the workers.

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Suggestions

It’s known fact that Elegant Drugs Pvt Ltd is one of the top among Pharma companies

which provides almost all facilities to its employee. But still it has not noticed some if the

problems. So I would like to give some suggestions which ware the result of my survey

undertaken.[Questionnaire& personal interview.]

1. As most of the workers are partially uneducated, the company should provide

some education & training programme.

2. The organizations should conduct induction training programmes at least twice in

a year to the workers whose performance is bad.

3. Around 40% of the workers are below SSLC & illiterate. Such workers may not

understand the objectives & policies of the organizations. Therefore minimum

qualification must be fixed by the company for appointing new employee.

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QUESTIONNAIRE

Section: I

Personal Profile

Employee code:

Designation:

Age:

a) 18-30 years [ ] b) 30-40 years [ ] c) 40-50 years [ ] d) 50-60 years [ ]

Marital Status

a) Married [ ] b) Unmarried [ ]

Section:II

Study Profile

1. Elegant Drugs is working towards its employee welfare

Strongly agree

Agree Neither agree/Nor disagree

Disagree Strongly disagree

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2.As an employee of Elegant Drugs, are you satisfied with the basic working conditions provided by the organization?

Yes No

3 Financial and non financial benefits are must for an employee for his dedicated work, are you catered with the same?

Yes No

4. How are the recreational facilities in the organization?

Very good Good Average Satisfactory Bad

5.Family pension, Bonus, Meritorious awards are given to me Very good Good Average Satisfactory Bad

6.To increase the performance of the employee’s regular training is provided

Strongly agree



7.Safety is given highest priority in your organization

Strongly agree



8. What is your opinion about the grievance handling procedure?

Very good Good Average Satisfactory Bad

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9. What is your opinion about intensity of disciplinary action in the organization?

10. All these welfare measures provided to the employees have increased productivity

Strongly agree



Thank you.

Section I

Data analysis and presentation 1. Age:

Age group No of workers18-30 years 2430-40 years 1540-50 years 850-60 years 3

Total 50

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High Medium Low

2 Marital Status:

Number Married 37

Unmarried 13Total 50

0

5

10

15

20

25

30

35

40

Married Unmarried

Marital Status

Section:II

1. Elegant Drugs is working towards its employee welfare

Numbers Strongly agree 11 Agree 29 Neither agree nor disagree 9

Disagree 1 Strongly disagree 0 Total 50

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2. As an employee of Elegant Drugs, are you satisfied with the basic working conditions provided by the organization?

Numbers Yes 40 No 10 Total 50

3 Financial and non financial benefits are must for an employee for his dedicated work, are you catered with the same?

Numbers Yes 35 No 15 Total 50

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4. How are the recreational facilities in the organization?

NumbersVery good 17

Good 22 Average 11 Satisfactory 0 Bad 0 Total 50

5. Family pension, Bonus, Meritorious awards are given to me

NumbersVery good 12


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6. To increase the performance of the employee’s regular training is provided



7. Safety is given highest priority in your organization



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8. What is your opinion about the grievance handling procedure?

NumbersVery good 13


9. What is your opinion about intensity of disciplinary action in the organization?

NumbersHigh 18

Medium 25 Low 7 Total 50

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10. All these welfare measures provided to the employees have increased productivity



Executive summary

Yet to type.

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