Design of the study Title of the study: COMPETENCY MAPPING Statement of problem: Companies are realising the need

for ensuring that competent people are available for performing various critical roles. Right competencies are the key to superior performance to handle such roles thus identifying those competencies of the employees is the key process of competency mapping and the purpose of this study. Scope of the study:

Objectives of the study: To gain insight about the future upcoming concept called competency mapping at the place where I my doing my internship KEMWELL BIOPHARMA PVT LTD To

Methodology : 1. Primary data 2. Secondary data Primary data: Primary data sources are always the most important collecting primary data with the help of all the managers, executives and senior executives of all the departments and individual discussion with the other workers in all departments. Secondary data: The secondary data is collected from the training material provided by KEMWELL BIOPHARMA PVT LTD and also related company personnel manual, competency mapping related books written by T.V RAO.

Company profile
KEMWELL was established in 1980 by Mr. Subhash Bagaria. Many of the current staff have remained with the company for over twenty years and include a founder. This highlights the practical experience of designers and applications engineer as being extremely high. KEMWELL is a leading provider of contract manufacturing and development services for pharmaceutical products in India and Sweden. It is one of the largest formulations in India serving Blue-chip multinational/India pharmaceutical companies for over 20 years. Whether the needs are for formulation development, analytical support, clinical batch production, commercial-scale manufacturing or packaging,

KEMWELL is your ideal strategic partner. Our goal is to deliver to every client quality service, every time. Nature of the business: KEMWELL BIOPHARMA PVT LTD is the leading formulation contract manufacturer for multinational/ Indian pharmaceutical companies for over 20 years. It supplies to over 80 countries worldwide. Customers include5 of the 10 pharmaceutical companies in the world such as AstraZeneca, GlaxoSmithKline, and Johnson & Johnson, Novartis and Pfizer. Vision:

Mission:

QUALITY- THE FOUNDATION OF SUCCESS KEMWELL meets current Good Manufacturing Practices (cGMP) (Current Good manufacturing Practices) as per international guidelines and continues to invest in people, processes and equipment to ensure that KEMWELL remains a Quality leader in every aspect of our business. Our Quality System is the foundation of our operations and through comprehensive SOPs, rigorous training and a range of process controls; we ensure that all products meet the highest quality standards.

THE QUALITY SYSTEM: Quality system conforms to cGMP conditions and has WHO GMP Certification in India and has been inspected by the USFDA, EMEA and Japanese regulatory authorities in Sweden. Facilities are fully approved and periodically audited by Corporate Quality Teams of our customers. Encompasses all GMP related activities at the site including manufacturing, laboratory and validation. Systems in [place for deviations, complaints, change control, documentation control, CAPA, validation, pest control, training etc.

COMMITED TO Quality Compliance: The company is dedicated to strict Cgmp compliance and the methods, facilities and controls used for the manufacture, processing, packaging and holding of all finished pharmaceuticals produced at KEMWELL are in accordance with the applicable sections of c GMP

regulations. A continuing employee training program, equipment and process validation, and a self-inspection program are part of our commitment to Quality Assurance. The entire company is commited to ongoing quality improvement process. Special emphasis is placed on thorough documentation and review of the entire manufacturing and control process.The documentation system and customized batch documents assure that requirements have been met. These documents are reviewed and updated as necessary to maintain quality standards. KEMWELL maintains a 100% commitment to pure-play contract manufacturing for our customers, which include 5 of the top 10 pharmaceutical companies in the world namely Bayer , Glaxo Smith Kline , Johnson & Johnson , Novartis and Pfizer. KWMWELL has no branded products of its own in the market to avoid conflicts of interests with our customers. Inorder to meet the unique and dynamic needs of each client , KEMWELL has built worldclass infrastructure in manufacturing, quality control and assurance system, R&D labs and training facilities. Owing to their highly flexible and adaptable organisation, they currently manufacture 5 of the top 10 brands in India and supply to over 80 countries worldwide from Sweden. KEMWELL has entered an exciting new phase of R&D services. They are investing to expand the breadth and depth of our services to support projects from formulation to finished products . the labs will be equipped for formulation and analytical development, including stability studies, method development and validation etc. in Sweden , they can also provide services for QP release. KEMWELLs sites in india and Sweden can work in harmony tp provide you the best solution from both worlds.

METHOD DEVELOPMENT/ VALIDATION: (Drug Substance, Drug Product, Excipients) Forced Degradation Studies Stability Indicating Methods Impurity and Degradation Product ID Preformulation Studies Method Transfers

QUALITY CONTROL SUPPORT: EU Gateway Release and Testing: They offer this service to companies who wish to import products into the EU and require full analytical testing and QP release. Release Testing Stability Studies Reference Standard Qualification

Cleaning Validation Microbial Testing Preservative Testing

QUALITY ASSURANCE: The experienced QA staff can provide quality assurance support and auditing for the internal or contracted studies. The staff is experienced in auditing internal and external studies to assure compliance with GLP AND GMP as appropriate. They can also provide assistance in establishing new compliance programs. In 2008, KEMWELL set up a new R&D facility in Bangalore in partnership with the worlds leading pharmaceutical company GLAXO SMITH KLINE (GSK . This R&D centre has been set up to cater to GSKs global oral healthcare development projects.

ORAL CARE UNIT (OCU): ORAL CARE UNIT (OCU): GSKs sales in oral care amounted to $ 1049 million in 2007. Its leading oral care products are toothpaste and mouthwashes under the Aqua fresh, Sensodyne , MacLeans and Odol brand names. GSK Consumer Healthcare (CH) has an aggressive target to significantly grow the business by 2013. To enable this to happen, the R&D arm of the company has commited to doubling the number of projects running through its pipeline. A series of initiatives have been identified within CH and R&D to enable this target to be achieved. Specifically, a Global Resourcing (GR) department has been established to identify and qualify contractors in India to increase the capacity for delivering new products through to the launch phase. KEMWELL has been selected by GR as a preferred partner for the development of Oral Care Products. KEMWELL achieved this privileged status through their senior mangrment commitment to diversificatiob/ innovation , their ability to deliver a new GMP facility, skilled manpower and their commitment to planning, delivery and quality. GSK and KEMWELL share a relationship that apans over 20 years and have coolaborated on several pharmaceutical manufacturing projects in the past. They are now extending their relationship to meet the R&D demands of GSK. The newly established Oral Care Unit (OCU) at KEMWELL is a state of art GMP facility suitable for all requisite development activities prior to technical transfer of product for manufacture into a GSK facility. The facility and staffing have been put in place by KEMWELL in little over six months and the Unit is now fully operational. OBJECTIVES:

To learn and conduct the stepwise method of analysis of various finished products To learn the practical difficulties occurring during the process of analysis and also the methods to overcome them To perform and understand the working of various instruments To confirm whether the results obtain match with the specification value specified

human resource department: purpose and objevtive: To provide clear cut guidelines about the requirement and selection process followed at KEMWELL Pvt Ltd. To attract people with multidimensional skills and experience that suits the present and future organisational needs and strategies. To develop an organisational structure that attracts competent people to the company. Recruitment shall be as per formally approved organisational structure and head count. a) Organogram and manpower planning All the functional heads are required to review their manpower plan including trainees at the beginning of the financial year. This shall be approved manpower of the function / unit of the year. The manpower plan shall cover the head count and cost of all the categories of employees engaged by the organization at any point in time. Monthly MIS shall be published and reviewed by the respective functional heads to track their manpower budget with respect to head count and cost. Manpower planning by functional heads: The various functional head finalize the manpower requirement annually for various departments and forward it to the COO for approval , after which it reaches the HR department. This exercise is carried out annually on March 31st every year. b) Recruitment initiation Once an employee has resigned the company, the HR department will intimate the HOD of the same department to replace the position if required. HOD will raise a manpower requirement form. c) Travelling expenses In case of an outstation candidate being called for an interview by the client he/she shall be reimbursed the travelling expenses as per the clients Re-imbursement policies. d) Quality standards The company strives to excel in all the services provided and commits to offer quality services provided and commits to offer quality services to clients matching the best industry standards.

The company shall understand the clients requirements in terms of the skill sets demanded by the client to the best possible accuracy and would send only the resumes that match the clients requirements after our initial screening e) Confidentiality The company shall treat with total confidentiality, all the information provided in terms of job description , number of positions, compensation and all other relevant details No poaching f) Ethical obligation The company shall not indulge in head hunting for candidates from the clients organization, to service any of other clients. The company shall be transparent in all of its dealings with the clients. g) Mode of recruitment Employee referrals The existing employees are given an option to refer their friends or relatives and the referred candidate are selected and the employees will be rewarded Data base A data base covering old employees and other unsolicited applications and are used for future purposes when the need arises Consultants When the vacancies cannot be filled internally, consultants are hired and an agreement is drafted and the position is filled.

PRODUCTS MANUFACTURED AT KEMWELL 1) GSK CH Crocin suspension 120mg/240mg

2) ANGLO FRENCH DRUG CO : Beplex Elixir Codylex Linctus Beplex forte Elixir 3) PFIZER Erythrosine Suspension Corex cough syrup Becosules syrup Broncorex Expectorant Benylin-T-Expectorant Corex DX- cough syrup 4) MICROLABS Meconerv syrup Allercet syrup Dolokoff Dolo suspension Dolo suspension 125mg Dolo suspension 250mg Ventryl expectorant Salbid expectorant Antepar syrup Actified DM cough syrup Dilo-BM expectorant Dilosyn expectorant Piriton expectorant Zupar suspension Cobadex syrup Dilo DX syrup Ventrolin syrup Calpol suspension 120mg Cetzine syrup Ventrolin expectorant

Infrastructure facilities Plant location: Plant is located 35km from Bangalore city Design philosophy: flexible and robust Proposed tablet area will cover about 13600sq meters on 3 floors with a footprint of 4200sq meters.

The plant is designed on three levels: 1st (Ground floor) : Finance , Accounts , and administration departments. 2nd (First floor) : Human Resource and Information Technology departments. 3rd (Second floor) : Quality Control and Quality Assurance departments. The plant is designed to produce different types and sizes of general tablets both coated and uncoated. Flexible batch sizes range from 20 kg to 600 kg. Manufacturing capacity of 2 billion tablets per year. Coating capacity of 540 million tablets per year for film and sugar coating. Pilot plant for formulation development and also for supplying materials for clinical trials. Flame proof coating areas and 300 kg granulation area will cater to needs of solvent coating or granulation. The facility will be supported with a separate utility block and treatment plant. Achievements : KEMWELL acquired PFIZERs plant in Sweden , the deal was completed within one month without disclosing the purchase amount. According to Mr.Subash Bagaria the facility in UPPSALA was expected to add Rs.200 crore to KEMWELLS turnover along with a vital European footprint for its contact manufacturing ambitions. The deal amount would be partly raised as debt from one or two Swedish banks. Management team: KEMWELLS friendly accessible and responsive management team is dedicated to customer satisfaction. The company places a premium on intelligence, motivation and positive attitudes . Chairman and Managing director- Mr. Anurag Bagaria

Chief Operating officer- Mr. SK Raman Technical Director- Dr. A R S Paripoornam Finance Director- Mr. S R Chandak Vice President- Mr. Anurag Bagaria General Manager- Projects- Mr. P Guruswamy General Manager- Commercial- Mr. Y K Kansal Board of directors Chairman and managing director Mr. Anurag Bagaria Chief operating officer- Mr. S K Raman Finance director- Mr. S R Chandak Former MD GlaxoSmithKline, India Mr. Humayan Dhanrajgir Based in Sweden with 30 years of pharma experience at AstraZeneca and Pharmacea Mr. pereke Oldentoft. Swot analysis Strengths High technology oriented company. Large exporter of pharmaceutical products. Latest global management practices in contract manufacturing with 100% commitment. Latest scientific inputs from UNIVERSITY OF UPPASALA. Customized ERP system. Seamless integration with customer systems. Largest manufactures of nasal drops,tablets,liquid orals,creams in india. Accreditation with GMP standards. WHO manufactures of top 5 out of10 in india. Weaknesses Kemwell has no branded products.

 The thought competition from global companies like GLAXO, and others. The problems in patenting the problems. Oppurtunites The global growth of diseases. The increase in oppurtunities in contract manufacturing of pharmaceutical products. The expansion of market leading to global market. Threats Heavy competition from global companies. Decreasing profit margin on pharmaceutical products.