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

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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 31st 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

STAFF

81

WORKMEN

25

GRAND TOTAL

141

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.

Continuous Continuous Improvement Improvement Continuous Improvement

Employee Involvement

Technique: SGA’S, KBP, BPR KAIZEN etc.

Tools: QC Tools Problem Solving

Vision Mission Policy

Commitment

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)

0100200300400500600700800

2001-02

2002-03

2003-04

2004-05

2005-06

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)

0

100

200

300

400

500

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)

*Net of Excise duty and sales tax **Post 1:1 Bonus Issue

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. & Tax 23.43 25.50 32.48 35.10 32.27 53.90 90.49 122.49 120.57 103.00

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 Shares(Rs.) 13.65 15.56 17.14 20.89 16.38 25.62 49.49 63.41 **32.28 25.59

Book Value Per Share(Rs.) 100.08 109.61 120.65 130.60 140.58 125.63 169.44 220.54 **135.04 154.36

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:

Empty trolley Trigger is ready 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.

Assembly Operation

Store

Full trolley

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

LAYER SEPARATION

PRODUCT FOR DESPATCH

REACTOR (REACTION VESSEL)

CENTRIFUGE

REACTOR (CRYSTALLIZATION)

FILTER

SIFTER MACHINE

BLENDER

MILLING MACHINE

DRYER

TESTING

PACKING

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:

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Oil & grease separator

Tertiary System

Secondary Treatment

Primary Treatment

Neutralization process

Outlet for Garden

Oil & grease separator

Neutralization process

Primary Treatment

Evaporation Solar Evaporation

ETP process

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.