An overview of __ _ _ _ _ _ _ _ __

Ipca Laboratories Limited

H-4, MIDC, Waluj
Aurangabad
 DR. BABASAHEB AMBEDKAR MARATHWADA UNIVERSITY,
DEPARTMENT OF MANAGEMENT SCIENCE,
AURANGABAD.

This is certify that an INPLANT REPORT

On

Ipca laboratories limited

Partnering Healthcare Globally

Submitted By

Director Guide

Date:

Important
Guys
These Projects Are For Your Reference Only.
You Supposed To Make It By Your Own. If Any one
got any of Doubt that U Just Completed Your Project
By Just Copying And Pasting From These Projects
Then This Is Violation Of My Restrictions.

So Please Use U R Mind Before Using It Right Away.

Thanking You
 CERTIFICATE

This is to certify that ---------------------------------------- a student of M.B.A.

II semester from ------------------------------------------------------ University
has undergone in-plant training and done project work on “six sigma” in
our organization of 2 months duration i.e. from 01/06/2007 to 31/7/2007.

he possesses great enthusiasm and urge to gain knowledge. She has an

optimistic attitude that finds opportunities from difficulties; we found her
sincere and hard working.

We really cherish her presence in our organization. We wish all the best in
his future endeavors.

Thanking you,

For -----------------------

-----------------------
 ACKNOWLEDGEMENT

It gives me immense pleasure to express my sincere & deepest sense

gratitude that I had given an opportunity of working under the Guidance of
--------------------------

I am also very thankful to all department heads , all the shift incharges &
all the staff of the organization of the -----------------------------, ---------------
----For their kind help, unfailing cooperation & guidance during to the
successful completion of my summer training work & preparation of
manuscript in the present form.

I an extremely grateful to our director

Thanking you,

Yours friendly,
Industrial structure and development

The Indian pharmaceutical industry today is amongst the front ranks of the countries
science based industries with wide ranging capability in the complex field of drug
manufacture and technology. This highly organized sector is estimated to be worth US
$ 6 billion in domestic sale and another US $ 4 billion in EXPORT sales.

In other word pharmaceutical market, India has a share about 1.8% by value and about
8% by volume. In term of global ranking India is fourth in volume and fourteen in
value terms. Indian medicines are marketed at prices that are among the lowest in the
world in spite of maintaining highest quality standards.

Opportunities, Threats and Concern’s

A recent report by leading global consultancy firm says that the Indian pharmaceutical
industry is poised to a staggering US $ 25 billion by expanding its bases through
innovation and research

Indian companies are today focusing on global generic business increasing focus on
R&D.

Activity and alliances with multi national companies shall act as future growth drivers
for Indian pharmaceutical industry.
Content ………..
Company Profile
Ipca Today
Award & achievement
Board of Directors
Management of the company
Ipca group of company
Products
Organizational Structure
Human Resources Management
Financial Management
Purchases
Inventory Management
Production Management
Environmental Management
Quality control & Quality Assurance
Regulatory Management
Safety and Health Management
Conclusion & Suggestion
Company Profile
Innotech Pharma Limited
M/s Innotech Pharma Ltd. (IPL) originally promoted as Bosker chemicals Ltd. In 1993 by Dr. C.G.
Karanjgaorkar (CGK) and Mr. D.K.Bose proposed a set up a plant for manufacture of 600 TPA of
trimethoxy benzaidehyde (TMBA) at waluj Dist. Aurangabad, Maharashtra. Subsequently Mr.
D.K.Bose was unable to provide the necessary support and opted out of the project. IPCA
Laboratories (IPCA) joined the project as co-promoter. The entire paid-up capital of the company
of Rs.1050 lacks as on 31.12.99 was held by the promoters IPCA Rs.625 lacks (59.5%) and CGK-
Rs425 lacks (40.5%).

The company M/s IPL commend its normal operation in March 1998. the company had however
faced technical problem and was not able to achieve the desired parameters in terms of rated
output, solvent recoveries, yields and energy consumption due to certain technical faults in the
plant the profitability of the company was affected by steep reduction in price of TMBA from
Rs800/-kg envisaged t Rs.450/-kg and the plant was again shut down from July,1998 and re-start
its operation in September,1998 but the M/s IPL could not achieve the projected profitability/
viability and its net worth remained substantially negative.

NEED FOR MARGER OF M/S IPL WITH M/S IPCA

M/s IPL has cleared the dues of secured lenders, incurred the required capital expenditure, and has
also written-down it’s equity by 90% as per terms of SS, and in spite of marking cash profits in the
last 3 years, it’s net worth continue to remain substantially negative. Therefore, in order to make
the net worth of the company positive and to wipe out its accumulated losses, the profitability of
the company need further improvement and for the said purpose additional capital expenditures
are required to be incurred in r/o which Dr.C.G.Karangaokar & associates (CGK) have decline to
contribute.

Dr C.G.Karanjgaokar & associates, however, expressed their willingness to divest their stake
(about 9%) in the share capital of IPL and, therefore, M/s IPCA and Dr.C.G.Karanjgokar &
associates entered into a memorandum of understanding (MOU) on 25TH Spet 2003 vide which the
entire shareholding of Dr.C.G. Karanjgokar & associate stood transferred to IPCA for a total
consideration of Rs 425 lakh. After the said transfer of shareholding, IPL had become a wholly
owned subsidiary of IPCA.

M/s IPL has considered interalia the synergies on operations of both the companies (i.e. IPCA and
IPL), investments required to improve the production/ pre-productivity, and other benefit of
merger and, thereafter, has proposed to merger with IPCA. Accordingly, a Scheme of merger of
IPL with IPCA had been formulated and had been signed by IPCA and IPL ON 26TH September,
2003. Effective transfer date 1st April, 2004
SAILENT FEATURES OF THE SCHEME OF MERGER

I. With effect from the transfer date, all the liabilities o M/s IPL shall, without any further act
or deed, be and stand transferred to the transferee company, pursuant to the applicable
provision of the said Act, so as to become as from the transfer date, the debts, liabilities,
duties and obligations of the transferee company.

II. The activities of M/s innotech pharme limited (IPL) will be carried on in the name and
style of M/s ipca laboratories limited.

III. The transferee company shall have full rights to use the trademarks/ copyrights/ patents/
brands and the other intellectual properties belonging the transferor company on which the
transfer company has made an application for registration.

IV. All the employees of the transferor company shall become employee of transferee
company.

Ipca Laboratories Limited

IPCA was promoted by a team of technocrats in the year 1949 under the provision of the
company’s Act 19B. The present management took over the company in November 1975 when the
total turnover of the company was 54 lacs., the net income has soared to over Rs.750 crores as on
31st march 2006. Ipca enjoys the status of being one of the biggest manufactures in the world of
APLs Atenolol (Antihypertensive), Chloroquine phosphate (Antimalarial), Furosemide (Diuretic)
and pyrantel Salts (Anthelmintic) right from the basic stage.

Ipca in India features among India’s top 25 pharma majors in sales, and top 10 in prescription
count and brand equity. Ipca has maintained continuing leadership during the last three decade in
the antimalarial therapeutic segment commanding over 50 percent market share.

In domestic market, Ipca operates through its seven marketing division namely- pharma, Intima,
Activa, Innova, Bionova, 3C (Comprehensive, Cardiac, Care) and Hycare. These divisions
represent the entire major therapeutic segment, which include Cardiovascular, Neuropsychaitry,
Dermatology, Rheutamology, Orthopedics, Gastroenterology, etc. Put together, the seven
marketing division have field strength of over 1,900 trained personnel. Domestic sales account for
around 45 percent of company’s annual turnover.

Ipca has earned global recognition on the strength of its technological and qualitative excellence.
The company has forged strategic global alliances in the marketing of its formulation. Its products
are being exported to over 100 countries across the globe. Ipca has is representative offices on
Russia, Ukraine, Venezuela, Vietnam, Sri lanka, Kenya and phillipines and subsidiaries in
USA,UK,South Africa, Nigeria and Brazil. It has its own trained field force to promote products in
Africa, South East Asia and CIS countries.
Ipca’s modern manufacturing facilities are located at Ratlam, Indore, Aurangabad, Kandla,
Dehradun, Athal and Silvassa. These facilities conform to WHO-cGMP standards. Most of the

facilities have been inspected by leading international regulatory bodies of Australia, Canada,
Europ, France, Ireland, Italy, New Zealand, Netherlands, South Africa, UK, and have been cleared
for manufacturing products for those countries.

One more new formulation manufacturing unit is coming up at Pithampur, SEZ (Indore) meeting
international regulatory requirements with an initial capital outlay of Rs.60 crores.

Ipca has started developing a number of generic prescription pharmaceutical products. For
registration and marketing in United States of America. Six ANDA applications in respect of
products developed by Ipca are already filed with US FDA out of which one produces has received
US FDA approval in September 2006.

Ipca has an intellectual property management group to deal with management and protection of
intellectual property. Over 100 patent applications are field by Ipca till date in India, USA and
other countries out of which five patents, including one in USA, are granted till date.

Ipca’s manufacturing and marketing are based on the technical edge provided by its Research &
Development center dedicated to APLs and formulations. Professional from Quality, Regulatory
Affairs, Analytical Development, Logistics, Procurement, etc also support it.

Ipca has total employee strength of over 5000. This includes over 1900 field staff and over 250
technical staff working in various R & D departments. Synergy among all the function is brought
through corporate HR activities. The human resources department focuses on continuous
improvement in development of employees and the workplace environment. Performance is
rewarded through various monetary and non-monetary incentive schemes.

Company’s net profit for the year ending 31 st March 2006 stood at Rs.64 corers. Formulations
constituted 66 percent of the total income of 2005-06. The export income for the year accounted
for Rs.402 crores.

Recent milestone

 Ipca inters into joint ventures with Holley Group of china for marketing Artemisinin based
APL and formulations. Joint venture setup in SALF zone Sharjah UAE and named as
ACTIVA pharmaceuticals FZC

 Acquires cardiac brand ISORDIL from Wyeth limited.

 Forbes Asia, a leading US business magazine selected Ipca, for the third consecutive year
as one among the first 200 “Best under Billion Company” in Asia.
IPCA TODAY

 Ipca Launched Intima, 3 C, Hycare, Innova & Activa divisions for the
specialty products.

 Ipca ranked among the top leaders in anti- malarials, macrolides,

Antiemetic, and Cardiac Drug Therapy.

 11 manufacturing facilities in India

 Products available in over 400,000 retail outlets, a network of over 1500

wholesalers, Ipca manufactures over 150 formulations in various therapeutic
segments and dosage forms.

 Ipca’s Cardiovascular and anti-diabetic formulations together accounted for

33% domestic formulation turnover.

 Ipca Manufacture formulations for leading companies in the European

Community under supply agreements.
AWARDS & ACHIVEMENTS
 Ipca listed in Forbes Magazine’s list of 200 successful companies outside
the US with Annual Sales of under $1 billion

 “Trishul” highest award conferred by CHEMEXIL (Basic Chemicals,

Pharmaceuticals & Cosmetics Export Council) for outstanding export
performance (Large Scale Sector) for the year 1998-99

 “Life Time Achievement Award” for 2002-03 - by Chemexcil

For Export Performance, This is the highest possible award given by
Chemexcil and ranks above the Trishul Award

 Ipca is ranked 129th out of the 500 ‘India’s Most Valuable Private Sector
Companies’ by Business Today Magazine

 IDMA -Quality Excellence Award for the year 2001

 3rd Express Pharma Pulse Award for Best Overall

Performance in Group C
BOARD OF DIRECTORS:
R.S.Hugar - Chairman
Premchand godha - Managing director
M.R.Chandurkar - Managing director

Executive Directors:

A.K.Jain
T.Ramachandran
Babulal Jain
Dr.V.V.Subba Rao
V.A.Gore

Audit Committee:
Babulal Jain
Dr. V.V.Subba rao
V.A.Gore
Corporate Management Team____________________________

J.L.Nagori President- operation

Dr.Ashok Kumar President- R & D (chemical)

M.D.Sharma President- Domestic Marketing

Y.K.Bansal President- R & D (formulation)

Prakash Shanware President- HR

Pranay Godha President- Bulk Activity & Gen.

Rejesh Srivastava Sr. vice President- Commercial

N.Guhaprasad Sr. vice President- Int. Marketing

VICE PRESIDENT- LEGAL & COMPANY SECRETARY

Harish.P. Kamath
IPCA GROUP OF THE COMPANY:

Manufacturing Plant: Athal

Plot No.255/1, Village Athal

Silvassa 396 230, U.T.of Dadara & Nagar Haveli
Tel: (0260) 264 0301
Fax: (0260) 2640 303

 Formulation plant for Domestic & international markets

Operational since 1995
 Regulatory approval from:
MHRA-U.K., MCC-South Africa,
TGA- Australia, ANVISA-Brazil &
WHO- Geneva
 Type of product manufactured:
Pharmaceutical - Formulations
Oral solid dosage forms
 Production capacity per month:
600 million Tablets
 Total area: 103200 Sq Mtrs
 Constructed areas: 32000 Sq Mtrs

Manufacturing Plant: Aurangabad

H-4, MIDC, Industrial Area,

Waluj, Aurangabad-431 136
Tel: (0240) 2564 993
Fax: (0240) 2564 113

 API plant for Domestic & international markets

Operational since 1997
 Type of product manufactured:
Active Pharmaceutical Ingredients
And Drug Intermediates
 Production capacity per month:
50-60 MT
 Total area: 37,100 Sq Mtrs.
 Constructed areas: 13,796 Sq Mtrs
Manufacturing Plant: Dehradun (U.A.)

C6, Sara industrial State, Chakrata Road,

Rampur, Dehradun (U.A.) 248197
Tel: 0135-654 2228
Fax: 0135-2728766

 Formulation plant for Domestic market

 Type of product manufactured:
Tablets & Capsules
 Production capacity per month:
8 million units in two shifts
 Total area: 17,140 Sq Mtrs
 Constructed areas: 10,000 Sq Mtrs

Manufacturing Plant: Indore

Plot No. 89A, B/90 Industrial Estate, Polo ground,

Indore 452 03 Madhya Pradesh,
Tel: (0731) 242 1172
Fax: (0731) 242 2082

 API & drug intermediates

Plants for Domestic & international markets
Operational since 1994

 Type of product manufactured:
Finished Active Pharmaceutical Ingredients
And Drug Intermediates
 Production capacity per month:
100 MT finished APL and
70 MT Drug Intermediates
 Total area: 6,503 Sq Mtrs
 Constructed areas: 4,826 Sq Mtrs
Manufacturing Plant: Kandla

Plot No.69 to 72, Sector-2,

Kandla special economic zone
Tel: (02836) 252 385
Fax: (02836) 252 313

 Dedication Betalactum plant for international markets

Operational since 1993
 Regulatory approval from:
MHRA-U.K., MCC-South Africa,
TGA- Australia, ANVISA-Brazil &
WHO- Geneva, NDA-Uganda &
MOH-Oman
 Type of product manufactured:
Capsules, Tablets & Dry Syrups of
Penicillin
 Production capacity per month:
95 million Dry syrup bottles
1.5 million Tablets
50 million Tablets
 Total area: 1,04,970 Sq Mtrs
 Constructed areas: 14,000 Sq Mtrs

Manufacturing Plant: Ratlam

Village Sejavata
Dist. Ratlam 457 002
Madhya Pradesh
Tel: (07412) 279 079
Fax: (07412) 279 083

 APL & Formulation plant for Domestic &

International markets
Operational since 1983
 Regulatory approval from:
APL & Drug Intermediates: USFDA
EDQM – Europe, TGA- Australia,
 MCC-South Africa, ANVISA-Brazil &
WHO- Geneva
Formulation: MCC-South Africa
WHO- Geneva, ANVISA-Brazil, IDA-
Uganda, PNA-Senegal
 Type of product manufactured:
Finished Active Pharmaceutical Ingredients
And Drug Intermediates & Formulations

 Production capacity per month:

250 MT (Finished API And
Drug Intermediates)
11 Million Tablets and 1.5 million bottles
 Total area: 2,72,900 Sq Mtrs
 Constructed areas: 43,000 Sq Mtrs

Manufacturing Plant: Silvassa

Plot No. 65 & 99 Danudyog Industrial Estate

Piparia, Silvassa 396 230, U.T.of Dadara & Nagar Haveli
Tel: (0260) 264 0850
Fax: (0260) 264 0646

 Formulation plant for Domestic & international markets

Operational since 2004
 Regulatory approval from:
WHO
 Type of product manufactured:
Pharmaceutical - Formulations
Oral solid dosage forms
 Production capacity per month:
10 million units
 Total area: 7,000 Sq Mtrs
 Constructed areas: 6,144 Sq Mtrs
Sales Depots and Regional offices: ____________________________

1. Ahmedabad
2. Ambala
3. Bangagolar
4. Chandigarh
5. Chenni
6. Cochin
7. Cuttack
8. Ghazibad
9. Guwahati
10. Haldwani
11. Hyderabad
12. Indore
13. Jaipur
14. Kolkata
15. Lucknow
16. Mumbai
17. New Delhi
18. Patna
19. Pune
20. Raipur
21. Ranchi
22. Zirakhpur
Products

Sr. No. NAME OF PRODUCT CAPACITY IN MT

/ ANNUM.

1. TRIMETHOPRIM 120 MT

2. TRIMETHOXY BENZALDEHYDE 480 MT

3. TRIMETHOXY TOLUENE 520 MT

4. 6 – BROMO METHOXY NAPHTHALENE 300 MT

5. PARA – METHOXY ACETOPHENONE 200 MT

6. PARA BROMO TOLUENE 120 MT

7. VERATRIC ACID 120 MT

8. ACETYL YARA YARA 200 MT

9. ANISOLE 300 MT

10. DL - NAPROXEN 120 MT

HUMAN RESOURCE MANAGEMENT
Human resources are very valuable resources for any organization; by using these
resources any organization can transformed its dreams and ambitions into realities
and achievements.

Ipca has total employee strength of over 5000(including all divisions). This includes
over 1900 field staff and over 250 technical staff working in various R & D
departments. Synergy among all the function is brought through corporate HR
activities.

The human resources department focuses on continuous improvement in

development of employees and the workplace environment.

Performance is rewarded through various monetary and non-monetary incentive

schemes. Extensive training is imparted on a regular basis to improve various
competencies that are identified.

HUMAN RESOURCE POLICY:

 To retain and attract best talent

 To provide career and growth opportunities

 To optimize utilization of human resources

 To recognize and reward employee

 Training and Development

 To create conducive work culture and atmosphere

 To provide relevant information

Man power status as on 10.07.2007 of Aurangabad Unit

MAN POWER

CATEGORY NUMBERS

SUPERVISOR 35

81
STAFF

25
WORKMEN

141
GRAND TOTAL
 Policy:
Following policies are provided to the workers by IPCA Laboratories Ltd:

1. Safety shoes policy

2. Mobile phone policy
3. Car policy
4. Travel policy
5. Leave policy
6. Uniform policy
7. Recruitment policy
8. Induction policy
9. Internet access policy
10. Salary & Wages policy
11. Training policy
12. Probation & Confirmation policy
13. Compensatory off policy
14. Visitors policy
15. Appraisal policy
16. Canteen policy
17. mediclaim policy
18. Loan & Benefit policy
19. Leave travel policy
Total Quality Management:

“It is a movement requiring systematic organizational approach in

delighting customer (both internal & external) on a continuous basis by involving all
people in improving products and business processing using appropriate technology
and problem solving tools”.

Total quality management an intensive long term effort

directed at the creation and maintenance of high standard of product quality and
services expected by customer. The object is significantly increasing the awareness
of all employee that, quality is vital to the organization’s success and to their future.
The business must be transformed into a unit which exists to deliver value to
customer by satisfying their needs.

There Are Some Steps Which Adopect By The Company For

Achieving Total Quality Management.

 5-s program is basically a group activity. Each and every person working area
involve in 5-s program i.e (segregation, systematize, sanitize, sanitize,
standardize self-discipline)

 All department and all employees from all levels participate in quality control
activities. All levels include a simple worker/ operator and a chairman etc.

 Company allot consistent priority for quality and it’s improvement

 Company having daily control and policy control exercise to find out if there
is any deviation.

 Company is very careful about the culture of quality assurance each

department of the company contributes to quality assurance.

 In company quality assurance continuously practiced till the defective level

drop to a few part per million.

 Company gives the training to supervisor and workers in the organization for
clarify the concepts of QA, QC, and TQM also.
 Employee
Involvement

Continuous Continuous
Improvement Improvement
Vision
Mission
Tools: QC Tools Policy Technique:
Problem Solving Commitment SGA’S, KBP, BPR
KAIZEN etc.
Continuous
Improvement
Financial management
Financial management is responsible for obtaining and effectively
utilizing the funds for the efficient functioning of the business. Therefore it includes
financial planning, financial administration & financial control. Ipca’s corporate
office and head office lactated in Mumbai all the financial transactions are going on
from its head office Mumbai. The financial result of the company is published in the
Annual report. The result are also display in the URL namely www. Ipcalabs.com.

The company’s net total income in the year 2005-06 is Rs.753.30 crores as
against Rs. 685.45 crores in the previous year’s growth of 10%.

Total Income (Rs. In crores)

800
700
600
500
400
300
200
100
0
2001- 2002- 2003- 2004- 2005-
02 03 04 05 06

The company’s focus on formulation business resulted into increase in

overall formulation sales to Rs.501.29 crores, an increase of 12% over previous year
formulations sales of Rs.447.59 crores.

The products of company are now exported to over 100 countries across
the globe. During the financial year 2005-06 the company’s international business
declined to Rs.401.83 as against Rs. 410.58 crores in the previous year. Formulation
export of the company declined by 11% to Rs. 209.98 crores and export of active
pharmaceutical ingredients (APLs) and intermediates increase by 10% to Rs.191.85
crores
.
 Total Export (Rs.in crores)

500

400

300

200

100

0
2001-02 2002-03 2003-04 2004-05 2005-06

The domestic formulation business recorded a growth of 38% at Rs

291.31 crores as against Rs. 211.15 crores in the previous year. The company
introduced 12 new products in domestic market. New products introduce during the
last three financial years now constitute nearly 24% of the company’s domestic
formulation sales.

As per MAT Marc’06 ORG IMS, Ipca laboratories Ltd recorded a

sales growth of 25.3% as against industry growth of 15.4% and the overall rank of
the company improved to 23 from 25 a year ago.

The companies consolidate financial statements have been prepared

in accordance with “Accounting Standard -21”, “consolidate financial statement”,
“Accounting Standard -23’, “Accounting investment in associate in consolidate
financial statement” and “Accounting Standard -27”

In Ipca’s Aurangabad plant following financial activities takes place-

 Day to day cash payment & other document being sent to their Ho for
accounting and payment.

 Central excise.
 Ten Years’ Highlights:
(Rs. In Crores)

1996-97 1997-98 1998-99 1999-00 2000-01 2001-02 2002-03 2003-04 2004-05 2005-06

Total Income* 255.56 274.49 316.32 340.10 358.64 416.89 484.32 622.74 685.45 753.30

Domestic Income 133.35 128.53 155.58 159.04 183.96 185.61 206.31 265.26 274.87 351.47

Export Income 122.21 145.96 160.74 181.06 174.68 231.28 278.10 357.48 410.58 401.83

Profit Before Dep. &

23.43 25.50 32.48 35.10 32.27 53.90 90.49 122.49 120.57 103.00
Tax

Profit Before Tax 18.21 19.40 25.44 26.92 22.09 42.95 79.32 108.00 101.55 78.39

Profit After Tax 17.06 19.45 21.42 26.12 20.47 32.02 61.86 79.25 80.71 63.98

Share Capital 12.50 12.50 12.50 12.50 12.50 12.50 12.50 12.50 **25.00 25.00

Reserves & Surplus 112.60 124.51 138.31 150.75 163.23 144.54 199.30 263.17 312.59 360.89
Net Worth 125.10 137.01 150.81 163.25 175.73 157.04 211.80 275.67 337.59 385.89

Net Block 95.83 104.12 117.81 135.14 154.86 143.27 149.88 195.92 322.46 373.52

Net Current Assets 98.45 117.10 128.53 135.01 177.67 179.96 210.11 248.27 268.52 243.23
Dividend (%) 40% 50% 50% 55% 50% 55% 90% 110% **55% 55%

Earnings Per
13.65 15.56 17.14 20.89 16.38 25.62 49.49 63.41 **32.28 25.59
Shares(Rs.)
Book Value Per
100.08 109.61 120.65 130.60 140.58 125.63 169.44 220.54 **135.04 154.36
Share(Rs.)

Net of Excise duty and sales tax

*Post 1:1 Bonus Issue
Purchases Department:
The mgt. of purchases dept. in pharmaceutical industry is
material procurement, developing venders and in quality with respect to the right
purchases value during procurement and control on inventory of materials are the
important factors.

Efficiency of purchases starts with proper planning of the need

for materials. The area of purchases dept. is largely than of optimizing the use of
internal and external resources to meet actual need in an efficient manner. The
responsibility of materials with right time with proper planning and with minimum
inventory carrying cost to the tune of satisfying the end users in respective
department within the factory and outside the premises.

On the step of raw material purchasing three departments are

mainly involves i.e. store dept, purchases dept, commercial dept. store department
sent the required quantity of material then commercial department give approval as
per the budget of the company. Purchase department ordered that material from
approved vendor.
The main objectives of purchases department should be
effective planning of the work, effective feedback, systematic co- ordination and
combination of efforts.

Objective:

 To achieve quality in minimum time.

 To develop and maintain standard vendors and purchases of material of
branded company.
 Gradual reduction on cost of row material.
 Efficient planning of work, effective feedback / systematic co-ordination
and combination of efforts which would result in optimum efficiency with
minimum cost.

The responsibility of the purchases department is to order or

purchases a raw material in right quantity and right quality as well as right time.
Purchases department have to work to work according to their SOP (standard
operating procedure).
Responsibility of the Purchase Department:

 Monitoring of purchases overall function.

 To maintain minimum inventory .
 Collection of raw material from transports godown.
 Guide and supervise the work of subordinates & be responsible for overall
purchases function.

While purchasing a material from the vendor the store asst. /

Jr. Officer of the purchases dept. have to prepare the purchases order first. In the
SOP of purchases department their is some procedure for placing PO (purchases
order)

 Receive approved purchase requisition from the concerned department.

 Invite quotation for the material to be order from vendor.
 Select the quotation of vendor based on low price and good product
quality.
 Negotiate the term and conditions with the vendor.
 Fill the required details in purchases order.
 Forward the PO to the Authorized signatory for signature.
 Place the order to the vendor.
Just-in time
JIT approach which eliminate all sources of waste in
production activities by providing the right part at the right place at the right time.
JIT system results in much less inventory, lower costs and better quality.

For certain type of production and as a bridge to production

and as a bridge to management of some concrete results which have achieved from
JIT system and implementation approach designed to gain maximum benefit from
JIT.

JIT process:

JIT uses a simple parts withdrawal system called ‘Kanban’

to pull parts from one work center to next parts are kept in small containers and only
a specific number of these containers are provide when all the containers , the
machines are shut off and no more parts are produced until the subsequent (using)
work center provides another empty container.

Kanban trolley and containers:

Full trolley

Store

Empty trolley
Trigger is ready

Assembly
Operation

In work-in-process if inventory is limited to available

containers and parts are only provide as needed, the final assembly scheduled pulls
parts from one work center to the next just-in-time to support production needs. If
the process stops because of machine breakdown or quality problems all process will
automatically stop when their parts containers become full.
 Store Department:
Store management is a part of overall function of Materials
management and this is an essential function in any manufacturing organization. The
responsibility of store dept. towards the row material starts from the receipt of raw
material. At the time of receipt of raw material the company follows some steps.

At the time of Receipt of Raw material and Packing material some

points company have to take into consideration.

 Receive intimation from security about arrival of raw material.

 The store supervisor should check the delivery challan / invoice and
lorry receipt and tally with approved vendor list if the supply tally with
approved vendor list, warehouse supervisor accepts to unload the
material.

 If the supply is not from the approved vendor, ware house supervisor
shall intimate to in charge commercial and purchases dept. and arrange
to get approved vendor form. Approved vendor form shall be valid up
to three consignments. For further consignment the vendor shall be
incorporated in approved vendor list.

 After checking the entire documents then unload the material in the
company premises.

The major part after receiving the material is to store the material in
safe place called store keeping. The scientific management of store keeping in
pharmaceutical Industry material identification, handling, proper storage and accuracy
in quality during receipt and issue of materials are important factors to the successful
operation of store.
The responsibility of store executive for safe keeping of materials
under his custody commence with receipts of all material and terminates when the
material are issued to the production department for manufacturing the products.
Issue of raw material:

1. Raw material requisition slip receives from production department.

2. Check availability of approved material quantity according to requisition if
not available returns the requisition to production.
3. If material is available to allot the AR number according FIFO (first in first
out) system and enter the details in raw material.
4. Prepare material issue tags.
5. Issue material inside the dispatching room.
6. Check again label on pack according to tags.
7. Transfer the material from original container to polythene bags by using SS
scoop.
8. after weighting the material from original container is to transferred to
respective place and affix label “loose raw material”

Production department should check the issued raw material and weight,
if found ok then requisition slip and arrange to transfer the material to production
department.

Objectives:

 Gradual reduction in cost of maintenance, consumption of materials

without affecting the quality of work.

 Carryout close supervision and adherence of materials as per safety

instruction.
Production Management:

Production management is the branch of management which

is related to the production function production may be referred to as the process
concern with the conversion or input (raw materials, machinery, information
material, manpower and other rectors of production) into output (semi finished and
finished goods and services) with the help of concern process(planning, scheduling
and controlling etc.)
Ipca Aurangabad unit is multi-products modern
manufacturing facility unit. The facility is semi-automatic were required critical
control.

Ipca Aurangabad plant consist

 Plant A
 Plant B
 Solvent recovery plant.

Production capacity per month is 50 – 60 MT.

Bulk Drug is a batch process having different stages as required by process, some
process may require 10 stages and some may required 2 to3 stages only.

Reactions:
Raw material are changed in reactor for particular reaction, e.g.
Friedal craft, Acrylation, Nitration, Condensation, Oxidation, Hydrogenation etc.

Reactor is a device, which carried reactions and having accessories

like stirrers, motor, condensers, receiver etc. material of construction is fixed
according to requirement of process.
All reactors are jacketed for utilities like steam, oil, cooling,
chilling, brine etc. for fulfill process requirement. After completion of reaction
carrying out work up of reaction, which includes distillation of solvent, extraction
with solvent, water, layer separation, acidification, basification etc.

These all are applicable for different stages.

In production process before isolating final product carrying out purification of

crude stage, includes distillation, carbon treatment, filtration and crystallization.
Distillation:
It is a process of purification, which includes vaporizations of crude
product at its boiling point and condensation with the help of condenser to get
products in its original state.

Carbon treatment:
This is mainly carried out improving color of product and removing
some impurities. In this process the crude material, is dissolved in some solvent or in
universal solvent like water and carbon is added, keep material with carbon for some
time say 1 to 2 hrs and then all R/mass is filtered through hyflow for removing
carbon & extraneous matter free material.

Filtration:

For carbon filtration, pressure filter, leaf filter, sparkles filter are used with
hyflow bed. Hyflow is a devise to retain fines and gives clear filtrate, which is tree
of carbon and any extraneous matters other than pure material.

The clear filtrate is then processed for either distillation of solvent followed by
crystallization or directly taken for crystallization in reactor.

After crystallization products is isolated by filtering through device like centrifuge,

ANF, NF etc.

Drying:
Drying of products is to carry for removing trapped solvent or water
from material and to use specification for test of LOD & %KF. Most general
practices are to use tray dryer, RVD.

Tray Dryer:
In production process having tray with different MOC like stainless steel,
PVC for carrying drying of acidic & basic material.

The material is charged in tray and trays are kept in closed cabinet and
external air is given through hot coil, which produce hot air to dry material.
RVD:
Rotocone vacuum dryer is a closed vessel with rotating device and
facility of vacuum.

The material is charged and after closing RVD it rotates with constant
speed. Material is warmed by external heat through jacket and vacuum is applied to
remove solvent with reduced pressure, which is taking care of decomposition of
material.

After getting desire limit of LOD & %KF material is unloaded and process for
milling, shifting and packing.
Milling:
It is a device which crushes the material to powder with roating cutters.

Shifting:
It is the device of sieving material to meet different practical size by
using different mesh size and vibration.

Packing:
Finally material is packed in containers with different MOC and
packing quantity.

The whole operation from drying to packing is followed on 0.5 Air flow to prevent
extraneous particles and bacterial impact. Material is then shifted to quantities and
duly tested there by QC.

After QC approval material is transferred to BSR.

Ipca having SRP (solvent recovery plant) the main aim of SRP is
saving the cost by recovering the spend solvents coming from the production plant.
The solvent are recovered as per the required purity specifications of the plant need.
These recovered solvents are reused in the production unit which is definitely saves
the production cost of the products.
Flow chart of Bulk Drug process:

Raw Material

REACTOR
(REACTION VESSEL)

LAYER SEPARATION

FILTER

REACTOR
(CRYSTALLIZATION)

CENTRIFUGE

DRYER

MILLING MACHINE

BLENDER

SIFTER MACHINE

PACKING

TESTING

PRODUCT FOR DESPATCH

Environment management:
Ipca has one of the few pharmaceutical companies in India with proactive and
progressive policy on environment management. The company has invested a very
large amount in putting up a world class effluent treatment plant regarded as a
showcase in the pharmaceutical industry.

The Ipca manufacture various Bulk Drugs. During the manufacturing different types
of chemical and physical reaction occurs in which many gases generates and also the
effluent which we thrown out after the process. This effluent contains lot of organic
and inorganic impieties which we can not directly spend to MIDC drainage line. We
have to give a chemical and biological treatment to that waste to remove organic and
inorganic impieties i.e. is called waste minimization. The out let waste is used for
process in production, cooling tower, boiler & domestic purpose. The hazardous waste
is sent outside for incineration.

Objectives:
 The outlet treated water send to production for process use,
domestic purpose, cooling tower & boiler.
 The biological waste sludge after composting is used as a manure
 Reduce volume of hazardous waste.
 To work towards minimizing waste.
Process:
1. Oil & Grease separation:
Oil & Grease separation is the first step in ETP process. In this
process all the water collect in one tank.

2. Neutralization Treatment:
After oil & Grease separation all the collected water process
under the acid base treatment. It means neutralize the collected water.

3. Primary treatment:
This treatment is use for removing solids and organic
matter from the water by using alum.

4. secondary treatment:
This process directed towards the removing of biodegradable
organic and suspended solids by using floaters.
 5. Tertiary treatment:
In this treatment sand bad and Carbon bad are used for
removing the hazardous matter which is left from the secondary treatment

WASTE MANAGEMENT:

Waste water treatment

ETP (Effluent treatment plant)
Biological Treatment: Inorganic waste Treatment:

Oil & grease Oil & grease

separator separator

Neutralization process Neutralization process

Primary Treatment Primary Treatment

_________________

Secondary Treatment
Evaporation Solar Evaporation

Tertiary System
ETP process

Outlet for Garden

Outlet for Garden
Quality control & Quality assurance:

Ipca’s Quality Policy

“We are in the business of manufacturing and marketing of

Formulations, Bulk Drugs & Intermediates for the Domestic &
International Market. In producing quality
products, we strive to strictly adhere to National & International
regulatory requirements. We are committed to continuously
improve upon our quality standards to fully satisfy our customers.”

Quality control department is responsible to execute the following

duties:

1. Define detailed procedure (SOPs) for efficient working of the department.

2. Approval of the specification of raw material, in-process materials, recovered

solvent, intermediates, packing materials, finish products. If there is any change or
modification, in the specification follow the change control system and get it
approved by QA.

3. Sampling of raw materials, packing materials, intermediates and finish

products and release or reject of each batch bases on the analytical results.

4. Release or reject packing and labeling material and the final container
in which the finished product is to be packed.

5. Evaluate the adequacy of the condition under which raw material and the
finished products are stored.

6. Evaluate the quantity of the finished products are stored.

7. Maintain control samples and record for the key raw materials.

8. Maintain control samples and record for the finished products.

9. Establish and when necessary revised control procedure and specifications.

 10. Examine returned products as to whether such products should be released,
reprocessed or destroyed.

11. Document all type of analysis in a proper way. Other part of documents
includes preparation of department manual, Standard operating Procedure.

12. Carry out the stability study of finished products as per protocols as per QA
SOP on stability study. Stability study Inward register shall be maintained in QC
Dept.

Quality Assurance department is responsible to execute the following

duties:
1. To ensure that all necessary records are reviewed & complied before release of
finished & Int. products.

2. To ensure Adequate Control of issuance of BPCR for Batch Execution.

3. To carry out self –inspection as per schedule.

4. On line BPCR observation to the manufacturing facilities.

5. Daily cGMP Rounds in plants & Store as per schedule.

6. Maintain stability schedule, Monitor stability as per checklist.

7. To establish & ensure the system / procedure are implemented in different

function.

8. To ensure that MPCR received form production are properly evaluated for
correctness. & its approval.
Regulatory management:

Liasioning Management

Various statutory compliances and regulatory approval requirement to run

the plant under the various laws.
Procedure of Main license is under:-

Central Excise Department: - Excise registration is requirement under

Central Excise Act 1944 for manufacturing any excisable commodity.

Document Required for Registration:-

 Request Application on Letter head.

 Application in Annexure –I format (Specified by Department)
 Copy of Board resolution authorizing employees concerned for
authentication of excise documents.
 Copy of PAN Card .
 Copy of Memorandum and Articles of Association
 Copy of MIDC lease agreement and possession receipt
 Drawings of floor wise layout equipment.
 Copies of ammonia print of site plan indicating Finished Goods Ware
house.

 Service Tax Registration certificate –Goods Transport Agency Service .

 Request Application on Letter head.

 Application in ST –1 format (Specified by Department)
 Copy of Memorandum and Articles of Association.

Explosives Department: - Explosive licence is required for storage of

Explosive product.

 Document required for obtaining petroleum class “A “ , “B” & “C” licence

 Request application on letter head .

 Drawings “Explosive license area layout”.
 Form VIII – Application for the grant amendment/ renewal/transfer of a
licence to import and store petroleum.
 Licencene charges .
  Safety and Test Certificate of Tanks from competent authority.
 Original NOC from local district Authority (Police Commissioner) with
site plan duly endorsed by his with his official seal thereon.
 Specimen signature of the person authorized to sign the correspondence
intented for this department in connection with the licence .

Food and Drugs Administration (FDA):- The drugs licence is required for
manufacturing of Drugs under the Drugs and cosmetic Act.

Period - 5 year’s
Renewal - after 5 year’s

Documents requirement .

 Covering letter duly signed by Company’s MD only .

 Application in Form 24.
 List of products in triplicate.
 Plan of the premises.
 Xerox copy of qualification certificate of competent person along with
his appointment letter and confirmation letter.
 Consent letter of the competent person.
 Specification & Method of Analysis.
 List of Raw Material Used.
 Brief Manufacturing Process.
 Flow Chart of Drugs.
 Specimen of Printed matter of the proposed product.
 List of Directors.
 Copy of memorandum and Article of Association.
 Copy of Power of Attorney to sign the document related to FDA.
 Copy of old Form 25 A (Manufacturing Licence.)

Industrial Safety & Health

 Factory Licence: This licence is required for registration of factory and

running the operation under “The Factory Act 1948”.

Document requirement:

 Request Application on Letter head.

  Application in Annexure form No 1 and Questionnaire (Specified by
Department – Application for permission to construct new factory to
extend existing factory and to take into use and existing building as a
factory .
 Appendix ( To be filled in , in case the factory is or will be situated in a
common compound under section 93 of the Factory Act 1948)
 Copy of Memorandum and Articles of Association
 Factory layout of department wise (All department ).
 Flow Chart of Manufacturing process.
 Stability Certificate.

Maharashtra State Pollution Control Board (MPCB)

Maharashtra State Electricity distribution co. Ltd. (MSED Co.Ltd.)

Power is the main source to run the plant .

For power connection the following document required .

 Request application on letter head .

 Licence from the central Government .
 SSI/Factory registration.
 NOC from MIDC
 Plot Possession certificate from MIDC.
 7/12 extract with industrial NA or Side MIDC.
 NOC from Municipal Corporation /MIDC/Gram Panchayat.
 NOC from MPCB.
 Memorandum /Article of Association of the company.
 KVA calculation Sheet.
 Point of Supply drawings in 10/12” Sheet.
 NOC from FDA in case of Pharmaceutical& Food Industries.
 List of Directors with their permanent address.
Sales Tax Department for VAT registration.
 New Registration for MST Number .

 Request application
 List of Additional places of Business in India
 List of Directors with PAN Number & Professional Tax No.
 Form No. 101 (Application for registration under section 16 of the
Maharashtra Value Added tax Act 2002.
 Copy of PAN Card
 Form of Statement of Applicant .
 Form No. 105 (Declaration /revised declaration under section 19 of the
Maharashtra Value Added tax Act 2002.
 Memorandum /Article of Association of the company.
Safety, Health and Environment policy:
Ipca establish and maintain a safety, healthy and environment through
his continuous Eco-friendly programmes aimed at products Safety and integrity,
personal safety accidents prevention and loss control.

Following pre-employment medical check-up is done by Ipca Lab.

1. General physical examination.

2. Ophthalmic examination.
3. Pathological examination.
a. Blood test
b. Urine test
c. X-Ray

Periodical and annual medical check-up is also done by IPCA.

For Personal Safety Company provide safety shoes and helmet for
selected department like production department. In bulk drug plants and
pharmaceutical plants basis of selection is exposure to hazard and protection required.
A safety shoe with steel toe cap and confirming to is standard procured by head office.

Fire fighting system, nose masks, hand gloves and safety goggles
also provide to the workers.

For healthy atmosphere company provide clean and neat canteen and
hygienic food in canteen. Company also provide good house keeping in plant.

Ipca’s safety and health environment program:

 Environmental Friendly Plants, Effluent treated water used for gardening.

 Medical Education Programme “ Medivision”Awareness programmes on
Malaria
 Relief measures during natural calamities like Gujarat earthquake. Blood
Donation Camp.
 Launched Web site on Malaria for creating awareness among people
Hazard Identification, Risk Assessment

• Identify hazards in all activities routine and non-routine.

• Assess the risks due to the hazards.
• Classify risks so that steps can be taken to eliminate the severe ones.
• The classification should lead to appropriate controls
• Both effectiveness and timeliness of actions should be monitored.

Risk Factors

• Chemicals
• Machine
• Material
• Tools
• Equipment
• Electricity
• Compressed Air

Activities in work place

• Routine Activities
• Non-Routine Activities
• Material Handling
• Utilities consumption
• Movement of People
• Waste Disposal

Consequences Due To the Hazards

• Physical Injury
• Chemical / Fume attack
• Fire/Explosion
• Electric Shock / Short Circuit
• Toxic Release
 Conclusion and suggestions:

In the competitive business like pharmaceuticals, the winner is inevitable

the one who can make the best quality of products at the lowest price.

A properly designed and executed management system can bring about

large economies in the operation of the company and protect a good image for the
company. However this required great discipline on the part of all the members of the
organization to adhere to the system.

Ipca is a Customer -Centric Organization, Customer satisfaction is

sacrosanct. This has translated into setting very high standards for Products, Services
and Quality.

To achieve technological excellence in operations, Ipca has adopted

State-Of-Art technologies to suit business needs and priorities facilitating competitive
edge to the Company. Free flow of communication with thrust on Progress, Policy and
People so as to evolve a participative work environment.

Business synergy of various group companies leading to over all

optimization of product cost, improved quality and customer services for market
dominance.

Ipca’s strengths are high product quality, state-of-the art technology, strong
R & D support, qualified and experienced human resources, good industrial relation
etc. it can be concluded that the company is having the necessary apparatus and
resources which will not only expand the company but also add to its profits.

The company maintains its growth during the year. The enhanced market
penetration, continued product mix improvements and ongoing cost management
programs have contributed to the performance.

In production area Ipca Aurangabad plant have to install a new cooling

tower to overcome from the thermal problem. company have to improve his
infrastructure.
In future ipca having great opportunities like:

 Growing demands for the products.

 Potential to become market leader.

 Strong brand name, scope for lowering the cost.