fy bba project

Done By: Mr.Rohullah

Name: Rohullah HussainiRole No: 50Class: FYBBABatch: D - (15-18)(S.S.Dempo College of Commerce and Economics)

Summer internship(2016)


Declaration

I, Rohullah Hussaini, student of S.S. Dempo college of commerce and economics hereby declare that I have completed my project titled “VerGo Clinicals” the information submitted herein is true and original to the best of my knowledge. This was done by me under guidance of Ms. Mamta Kane one of the faculty member of S.S.Dempo College of Commerce and Economics and Ms. Pearl Fernandes admin executive of VerGo Clinicals Pvt. ltd company” during the period of 18th April, 2016 to 12th of June 2016 in VerGo Clinicals Pvt. ltd company.

I also declare that this project has not been submitted and not shall be submitted in the future to any other college, university or institution for the award of any other degree or diploma.

Date: (…………………………..)

Place: S.S. Dempo College of Commerce and Economics

Signature: …………………………..


Acknowledgement

The success and final outcome of this project required a lot of guidance and assistance from many people and whatever I have done is only due to such guidance and assistance and I would not forget to thank them.

Special thanks to my teachers and my coordinators Ms. (Sonya ma’am) and Ms. (Mamta ma’am) to give me this project to improve my skills and my ability.

I respect and thank to Ms. Pearl (admin executive) and Mr. Prasil kolhapurkar (HR Manager) for giving me an opportunity to do the project in VerGo Clinicals Pvt. Ltd Company and providing me all support and guidance which made me complete the project on time. I am extremely grateful to them for providing such a nice support and guidance.

This project report entitled “VerGo Clinicals company” is a result of (8) weeks of hard work and constant effort. During this 8 weeks I got training in fields.At the end once again I thank to all people who helped me during internship.


Certificate from collegeThis is to certify that the project titled VerGo Clinicals division of VerGo Pharma Research Pvt. Ltd Company is an original assignment performed by Mr. Rohullah “Hussaini” for a period of eight weeks under my guidance.

This project is submitted by the student for assessment procedure of FYBBA at S.S. Dempo College of Commerce and Economics, Panjim-Goa.


Table of Content

Executive Summary……………………………………………….……... (1)

Introduction to VerGo Pharma Research Pvt. Ltd……………...…..… (2)

Introduction to VerGo Clinicals……………………………...……..…... (2)

VerGo Clinicals Values and Quality Policy……………………..…..….. (3)

Missions and visons………………………………………………………. (3)

History of VerGo Clinicals………………………………………………. (3)

Market share of VerGo Clinicals………………………………………... (4)

Competitors……………………………………………………………..... (4)

Company Structure…………………………………………………….... (5)

Hierarchy of company…………………………………………………... (6)

C.R (Clinical Research) department…………………………………… (7-8)

Pathology Department…………………………………………………... (8 -9)

Bioanalytical department……………………………………………….. (10 -11)

Biotech department……………………………………………………… (11)

Q.A (Quality Assurance) department………………………………….. (12 13)

PK biostatistics department…………………………………………….. (13)

Project Management department………………………………………. (14 -15)

Store Department………………………………………………………… (15 -16)

HR Department........................................................................................... (17-21)

Finance (account) department…………………………………………... (21 -22)

Taxation department………………………………………………….…. (23)

System Administration (IT) department……………………………….. (24)

Engineering Development department…………………………………. (24 -25)

Portor’s forces……………………………………………………………. (26 -27)

SWOT analysis…………………………………………………………… (28 -29)

VerGo Pharma Research Pvt. Ltd Company…………….…………….. (30)


Purchase department……………………………………………………… (31-32)

Manufacturing department……………………………………………….. (32-34)

Formulation Department………………………………….………………. (34)

Process Technology Transferring department…………………………... (35)

Learning……………………………………………………………………. (36-37)

Finding, Suggestion and recommendation……………...………………... (38)

Limitation of study, Methodology and Objectives…,,,………………..... (38)

Done by: Mr.Rohullah

Executive summary

This project requires 8 weeks to be done in any organization. I worked with VerGo Clinicals Company.my experiences with VerGo Clinicals has been informative to me. This project has provided me more experience with applying theoretical knowledge to practical use so I feel very fortunate to have attained this project.

The objectives of this project were to know the various functions and activities of each departments and organization.

VerGo Clinicals is a division of VerGo Pharma and it is a global clinical research organization that test the available drugs (just change the weight of impurity and API of drugs) on human being. VerGo Pharma is a contract research organization that produce medicines. VerGo Pharma has three branches in three sectors; VerGo Pharma Research (Verna), VerGo Clinicals (Corlim) and VerGo Business Development (Mumbai).

Admin executive of VerGo Clinicals Ms. Pearl has been given me schedule, according to that I could interact with the members of each department in certain days (depends on each departments) for getting data and knowing the functioning of each department through the researching, practical and interacting with members of each departments.

In addition she helped me in interaction with managers and employees, and also I had this opportunity to view process of testing the drugs on human beings and the whole process of manufacturing tablets in VerGo pharma Research Pvt. Ltd Company.

During this summer internship I faced with some barriers and limitations for gathering information and data; language barriers, time limitation and there were some confidential information’s that they did not want to disclose it to everyone.

By the way it was a big chance and opportunity for me that I understood the functioning, activities of each department and organization and the difference between taxation rules and other differences between India trade rules and Afghanistan trade rules.

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Introduction to VerGo Pharma Research Pvt. Ltd CompanyVerGo derived from “Verna and Goa” VerGo Pharma Research Pvt. Ltd company is a CRO (1) company and has many divisions, the divisions are:

VerGo Clinicals (Corlim) VerGo Research (Verna) VerGo Pathology (Corlim) VerGo Organic (Verna)

Introduction to VerGo Clinicals:

VerGo Clinicals Pvt. ltd Company is a division of VerGo Pharma Pvt. Ltd. Company. VerGo Clinicals is a global CRO (2) company which is located in Corlim of Goa. It was founded in 2012 by Dr. Nitin Broker and Mr. Prasad Keni in Corlim of Goa.

The basic activity of VerGo Clinicals is to test and study the available drugs on human beings. VerGo Clinicals has 108 employees that 15 of them are from outside of Goa. VerGo Clinicals carry out BA (3) and BE studies and VerGo Clinicals has two centers.

Pathology center Biotech laboratory center

VerGo Clinicals focus on customer’s satisfaction, delivery of quality service, and safe working environment. VerGo Clinicals is the first CRO organization in Goa.

VerGo Clinicals has 12 departments which they are;

1- Research and Development Clinical Research Pathology Bio analytical Research Biotech

2- Finance Account

3- HR& administration Human Resource System Administration (IT)

1 Contract Research Organization2 - Clinical Research Organization3 Bioavailability: The bioavailability of a drug is defined as the rate and extent to which the activedrug ingredient or active moiety from a drug product is absorbed and becomesavailable at the site of drug action.

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Store department, quality assurance department, engineering (maintenance) department, project management department, and data management department also covered in this report by me.

VerGo Clinicals Values: We believes in openness and transparency. Performance is a key to individual’s success. Respect for human dignity. Honesty and integrity. Innovate and initiate improvement. Team Working Corporation. Learning from bonafide mistakes.

Quality policy:” VerGo strives to achieve enhanced of customer satisfaction by timing delivery of quality services, meeting global standard in a safe working environment backed by innovation and continual improvement to satisfy the unmet needs of the global healthcare industry.”

Vision“VerGo Clinicals desires to be the first choice for global pharma and biotech companies to conduct clinical studies.”

Missions“Our mission is to partner with global pharma and clinical companies to meet their R&D goals and create value with innovative solutions.”

History of VerGo Clinicals:VerGo Pharma Research was founded in 2010 in Verna of Goa.by the time they felt for more study and found VerGo Clinicals. VerGo Clinicals was founded in 2012 by Dr. Nitin Broker and Mr. Prasad Keni in Corlim of Goa.

In 2012 VerGo Clinicals acquired 100 clinical beds facility.

In 2013 inaugurated clinical facility and approved by DCGI (4)

In 2013 first BE ( 5) was conducted at VerGo Clinicals.

VerGo pathology and laboratory centers was approved in 2015 by NABL (6)

4 -Drug Controller of General India 5- Bioequivalence: is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same.6- National Accreditation Board For Testing And Calibration Laboratories

3

https://en.wikipedia.org/wiki/In_vivo

https://en.wikipedia.org/wiki/Pharmacokinetics


Market share: As I mention it is a global CRO and new to market, in case most of the VerGo clients are from Europeans and Chinese companies. It is really difficult to survey market share of VerGo Clinicals, but still it is not imposable.

Market share of VerGo Clinicals is less than one over the world. It is not exact how much really VerGo Clinicals has market share they assume that their market share is less than one.

PPD company has 9% market share, Carles Revier laboratory 8%, Quintilers 14%, Covance 10%, VerGo Clincals has 0.5- 1% market share and others 58%.

Sales

PPD VerGo Clinicals Carles Revier laboratoryQuintilers Covance others

Analysis: VerGo Clinicals is new in market, small than its competitors and only it is in Goa of India due to these market share of VerGo Clinicals is too much less than its competitors.

Competitors: VerGo Clinicals is the only CRO organization in Goa it has many competitors inside and outside of India.

Synapse (Pune): Synapse Clinicals research organization was founded in2009 in Pune it has many branches over the world.

Siro Clinpharm (Mumbai): This was an Indian CRO which was founded during the year 1996 by Dr. Gautam Daftary. The company was started operating in Mumbai. The European headquarters of this CRO is located in Greece.

PPD: PPD is one among the leading clinical research organizations which was founded during the year 1985. This company has its offices in as many as 50 countries with a total number of 84 offices.

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Analysis: VerGo Clinicals has many competitors, the competitors have expansion market than VerGo Clinicals and spread all over the word and India. so VerGo Clinicals is new to the market for VerGo Clinicals it is hard to compete with its competitors in this case the market share of VerGo Clinicals is too less than its competitors.

Company’s structure

5

MD(managing director)

CEO

Quality assuranceSite head

R&D (clinical research, bio analytical research, pathology and biotic departments)

HR

Store department

System Administration (IT)

P&K biostatistics

Project management

Account and taxation

Engineering (maintenance)


Hierarchy of VerGo Clinicals

6

managing director

CEO

site head

HOD (head of departments managers

doctors

scientist

executives

nurses

technicians

officers


DEPARTMENTS STUDY

C.R (clinical research) departmentIntroduction to department: this is one of main department in VerGo Clinicals. They are getting the samples (blood, urine, plasma…) of volunteers and test the available drugs on volunteers (human beings). They take consent from volunteers before screening. They find the volunteers through newspaper and mouth through (advertising).

The drugs already tested on animals and human before and it is already available in market.

Company is responsible for the health of volunteers during checking and testing periods.

Activities:

They do screening (height, weight, BMI, blood, ECG, urine and etc.) of volunteers. Checking of healthy volunteers for the study. Testing the drugs on human beings which are already available in market (comparison of

test and reference drugs).

They test the reference and test drugs on same volunteers and find the reflection of human body toward test drugs and reference drugs. For finding the reflection of human body toward test and reference drugs they need healthy volunteers to get exact results. They get the samples (blood, urine…) and send to pathology center for study of disease and healthy volunteers.

Process flow:

Step1: They find the volunteers through newspaper and mouth through and register the volunteers. For registration they take consent form, making card registering to system and security.

Step2: In second stage they find BMI and take the blood, urine… samples to find out the healthy volunteers. In this stage they do all checkup for finding healthy volunteer even do x-ray and ECG. They take the samples and send to pathology for disease study.

Step3: They get the report form evaluate and check whether the volunteers are healthy or no. If volunteer be healthy than they do randomization if a volunteer does not be healthy they reject the volunteer. In this stage they divide the volunteers in to two categories on first category they test the reference drug and on second category they test the test drug on them. After the testing the drugs they get the samples and send to BA department for analysis.

Step4: The bioanalytical department send the report of their analysis to CR department once again they review and send to project management department. The PM department check whether is it according to protocols or no than send to clients.

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Department structure:

Randomization: they divide the volunteers in to two part on 1st group they are testing the test drug on 2nd group they’re testing the reference drugs after washing periods again on 1st group they are testing the reference drugs and on 2nd group they are testing test drugs.

Learning:

I learned how this department running. As BBA student I did volunteer registration, I learned how to behave with volunteers and

how to motivate them to persuade people to become volunteers. I learned the process of testing the reference and test drugs and randomizations.

Recommendation: Health is important to all, every drug has side effect try to inform the volunteers about the affection of drugs in details.

Pathology department Introduction to department: this department doing study of volunteer’s samples (blood, urine, plasma) whether they are healthy or no. They are checking the disease (HIV, HCV…) on volunteers’ samples. They receiving these samples from CR department and report to them.

Activities:

Researching on samples whether the volunteers are healthy or no. Finding the levels of glucose, cholesterols, Na, K, Cl, bilirubin, PH, protein… in samples Testing the samples for disease like HIV, HCV and HBSAG.

8

Head of Departm ent

senior reseach scientist

doctors team

nurses & phelobotom ist


Process flow:

Steps1: They receive the samples from CR department than register the samples to software with the codes.

Steps2: They take the urine samples and find out the level of glucose, bilirubin, PH. They do centrifugation on blood samples and find the level of Na, K and Cl in blood.

Steps3: They do centrifugation for five minutes than search with Microscope for bacteria, cells… on urine samples. On blood samples they find out the level of glucose, cholesterols and bilirubin with Biochemistry Pand Machine. After this they search for HIV, HCV and other types of disease.

Steps4: Whatever they get the result they report to CR department back.

Structure:

Learning:

I learned how it functioning. I learned what they are doing on samples, how they register the samples and how they

find the healthy samples. As a BBA student I leaned registration of samples, making report of samples.

Recommendation:

Testing more disease besides testing only HIV, HCV and HBSAG disease. Because health is important to everyone (volunteers) and it also help the company (CR department) to get the best results.

B.A (Bio Analytical) department9

Lab director (head)

Assistant lab director

(Head) lab technician

TechniciansQuality assurance

Executives


In this department analyst analyze the samples which comes from C.R department.

Process flow of samples (plasma, blood …)

Description: the BA department receive samples from CR department than keep the samples in deep freezers. They do analyze and compare the test with standard samples by LC/MS/MS machine. They send the results to PM department and after reviewing of PM department the reports go to sponsors.

Activities:

Sample preparation: analyst prepare chemicals solvent( methane) for process of samples Balance room: two machine balance are there

1- Analytical balance: analyst getting the weight of chemicals substances.2- Ultra micro balance: comparing the drugs with standard drugs.

Standard drugs are kept in machine in certain environment.

Doing drugs concentration and injecting samples with standard drugs through the LC/MS/MS machine. Through this machine analyst analyze the drugs how it effects on human being and how the samples shows reaction with standard drugs and sample drugs.


Process of materials in BA department: Analyst make the requisition than send it to head of department for approval than send it to store department. When they received the materials they have inventory inside the BA department. They sign when they use the materials.

10

Head of department

IQM

Documenter

Team leaders

Analyst


Learning:

I learned how they receive the materials and the process of materials. I learned how this department running, how they are making the SOP’s and how they

process the samples to get the results. I learned how they analyze the samples

Biotech department The main activities of biotech department are study on impurity and API (7). So after

practicing and testing the different weights of API and impurity she analysis how the new drugs effects on mice with new weight combination of API and impurity.

Function:

Drugs are made of many components, main component (API) and sub components (impurity) so biotech department studies about the API and impurity. Biotech department compare the deferent weight of API and impurity in drugs and how it effects on body. Manly the biotech department has animal tissue culture so they test it on mouse cells.

Structure;

Research Scientist reports to CSL department directly.

Q.A (quality assurance) department Each departments make the SOP’s than it comes to QA department. They gives ideas and

review the SOP’s for new improvement. Draft SOP’s goes to each department (head suggestion) and finally SOP’s goes to a

person who has written it.7 -Active Pharmaceutical Ingredients are portions of any drug, which are active.

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use and sign

inventory of BA

department

storehead of

department

analyst requisition

CSL head

RS ll


Making master copy of SOP’s and uncontrolled copy. Master copy remain with the QA

department. Uncontrolled copy goes to each department for changes it comes back to QA department.

Activities:

Assuring the quality. Storing the documents whatever the company do for prove to sponsors and any other

purposes. Checking the quality Approves and review of SOP’s. Monitoring CAPA (8). Controlling the activities (review) of department. Change control. Implementation of change.

Structure:

Department structure

All the procedure should be record. All the procedure’s SOP’s is written by by the writer than goes to QA department for review. QA department look after each procedure. They archive the documents.

Learning:

I learned how they control the quality, how they looking after the activities of departments.

As BBA side I understood that every things in company has special code for better control of organization.

8 Corrective action and preventive action

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Head of Department

Executives (looking after Bio analytical and CR department)

Archivist and documentation

executive


I learned about SOP’s that was new for me. I understood how they are making and how

they are controlling the SOP’s.

PK biostatistics (data management)Basic activities: statistical analysis, sample size calculation (AUC, Cmax …) and comparing them with inputs of protocols are the basic activities of data management department.

Description: BA department analyze the samples and send the numerical results to DM department. Data management department find out the maximum times the drugs go out from body, the maximum concentration of drugs and statistical analysis. The results go QA department for authentication. The results go to PM department from PM to sponsors.

Structure:

Learning:

I learned how he analyze the data, how he make the report. I learned how he compare the reference and test drugs concentration and maximum time

of test and reference concentration and how he finds these all. I learned how he assume the elimination time of drugs. And I learned how this

department runs.

PM (project management) departmentActivities:

Making protocols: the project management department is making the protocols, how the research should happen.

Making the consent forms in three language for volunteers (English, Hindi, Maruti) Monitoring the procedures.

Process flow chart:

13

s ite h e a d

e xe cu ti v e


Description: Generally the PM department receive the project from the clients than making the protocols give it to CR department and control the procedures. The results go to sponsors. For each project they are compel to take ethic committee and DCGI approvals for studies.

Structure of department:

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Clients (sponsors)

Protocols (how the research

should happen)

Clients (approvals)

Project management

Sponsors

CR

Site head

Executive lll


Learning:

I learned how they are making protocols, how it runs and how they control the procedure. I learned how they are making consent form and how they are getting evidence from

ethic committee and DCGI for better proof to volunteers that the testing has no side effect.

Store department As in introduction I mentioned that it is a CRO company so in this case this company is small also for this reason it has small store department that he reports to HR department his daily activity. Mostly in store department he store aprons, mask…for this case still he order to purchase department a weak ago before the departments start study we can say he order (just on time) when they start new study.

Reporting his daily activities and moisture of materials to HR department, the HR department inform QA department for better controlling of quality.

Recording proper ledger of GRN. Store the materials according to expiration date.

Store department has no exact system of keeping materials but all materials are registered in store department whenever any department needs materials he check the materials in system and give those materials that has less expiration date.

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Executive ll Executive l


Process flow chart

Description of activities: all departments give their requisitions to store department the store executive receives the requisitions, than the executive order to purchase department (located in Verna) the purchase department send them whatever they ordered. When the materials arrived to VerGo Clinicals the VerGo Clinicals guards check the materials than the store executive check the materials. If it was whatever he ordered then he sign on GRN( good received note)paper and then he gives the GRN paper to finance& account department. If the materials weren’t whatever he ordered he reject that. Other departments received the materials from store department. If any department needs materials the executive of Store department see the requisition that if the finance manager signed the requisition then he give the material to prevent from slip requisition.

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recieving requisition

ordering to purchase department

checking of materials

making GRN

finance and account department


Learning:

In store department I learned that how they control the materials, how they keep the materials and how they distribute the materials. I understood how to make GRN.

Recommendation:

As BBA student I suggest to store department have to use the FIFO (first in first out) system for giving materials to departments, because expiration date is too much important for this the VerGo Clinicals apply the drugs on human beings so if once the expired drugs have been applied on volunteers obviously it has horrible effect on volunteers. So it is job of store department to not let the drugs be expired.

Consequence numbers for issuing of GRN. Without consequence number finance department face with too many difficulties.

HR departmentThe key role of HR manger is managing and controlling the whole HR responsibility of organization which includes paying salary, compensation, recruiting and selecting, hiring, performance management, maintaining of personal files, policy development (leave, salary, working time, aprons, welfare, organization talent review, health policy and …)

Policies of HR department:

Working time policy:

a- 9 hours per day inclusive of break lunch Morning 15 minutes Lunch 30 minutes Evening 15 minutesb- Pick up and drop facility is provided for all associates as per schedules.

Highlights:

All associates need to work as per the shift schedule of department. Attendances are recorded at security gate all associates have to sign when they

enter and out to company.

Leave policy:

All associates are eligible for 30 leave for 1 colander of year which are distributes in three categories.

a- Casual -6 nosb- Sick leave -9 nosc- Privileged -15 nos

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Each associates can carry forwarded 45 PL’s for a period of 3 years. After which

it will get lapsed.

Aprons policy:

Each staff is issued 3 set of aprons Aprons are issued for individual by supervisor. The issued clean aprons are kept in the linen room. Associates to use one set of fresh uniform and give it to laundry after 3 days. Department vise growing procedures to be follow strictly.

Salary policy:

Pay every month through the bank transfer. Employees should provide bank details and account opening information. Each employee need to open account in the Axis bank and submit the account

number to HR department. Employees joined after 25th will be paid in next month. Attendance cycle is 25th of previous month to 24th of current month. If changes in personal details, employees should inform immediately. Advance salary will be paid for 3 months not over 50,000Rs

Setting of salary: When applicants come for interview HR ask about previous salary of them. HR arguing about salary with applicants separately than set the salary. The salary of each employee is not known for others.

Employee’s engagements and welfare:

Availability of full time doctors for consultation. Risk assessment for pregnant lady staff. Annual sports day celebrated (Corlim Vs Verna). In house sports events. Festival and birthday celebration Transportation. Early come early go and late come late go (2 hours) twice per month. Advance salary. Training session and leadership meeting Leave facilities

Restriction of mobile and jewelry:

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Safety is almost important for us. Due to safety reason use of mobile phone is prohibited inside the premises. Keep your phone in the security lock room. Avoid wearing jewelry.

Recruiting and hiring Analyzing the needs of department for new employee according to financial budget for

new position receiving requisition (define vacancy). In this stage HR do job analysis with what qualification and experience new employee should be hired.

Finding employee from three colleges and advertising through the employees some time they do internal advertising those who are really with good qualification and hardworking will be promote for new vacancy.

Documents submission: Applicants have to submit his CV, VerGo Clinicals application form and any other relevant documents.

Selecting Screening interview: in this stage they are taking interview for the purpose of selecting

those applicant who are suitable for company (sorting the applicants) mostly VerGo Clinicals use face to face interview.

Checking references: checking past period, police record etc. Reviewing the documents: reviewing the biographical data, work experience, education

qualification. Selecting those applicants who has more experience, education, good biographical and

lower salary. Physical examination: HR trying to find out the healthy applicants for this reasons HR

do medical examination. Appointment: talking about the date of joining and other regulation.

Training: VerGo Clinicals do training for improving the skill, knowledge, efficiency and attitudes of employees. VerGo Clinicals train the employees when they receives the new project, new employees and employee promotions.

Training is conducted for the development of carrier of employees through the seminars, presentations, and practical (on the job training). Training is conducted for better performance in VerGo Clinical by the members of VerGo Clinicals.

Determining training needs: All departments have their own annual assessment for the needs of training of the staff reporting to HR and also when new employee join to company.

Stablishing objectives: in this stage HR stablish the objectives of training, what is the desired result of training.

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Selecting the method of training: it is belongs to needs of training, if new project comes

to VerGo Clinicals only training through presentation but if new employee joined with VerGo the do practical training.

Feedback: HR department compare the results with performing of employees that they had before training.

Performance appraisal system: Performance appraisal refers to all those procedures that are used to evaluate the performance of employees. VerGo Clinicals use different method of appraisal but mostly use 360 degree method for evaluating the performance of employees. Aims of performance appraisal to VerGo Clinicals is to identify employee training needs and improve efficiency. Before they start the performance appraisal they measure the actual performance and standard performance if the actual performance be low than standard performance they appraise the employees.

Performance is evaluate thoroughly at VerGo Clinicals. During probation/training period, formal appraisal process is followed. Appraisal is conducted after (6) months Each confirmation may be awarded for high performers Fill up employee part and hand it over to your immediate senior(appraiser) On completion of probation/trainee period, confirmation is awarded.

Performance appraisal management and salary revision:

Salary revision is based the rating achieved through performance management system.

Annual revision is done in the month of April.

OTR (organization talent review):

personnel performance appraisal is taken at the end of every financial year by HOD and HR

Using 360 review method for better knowing about performance of employees. At the end HR, HOD &CEO discuss and take the final decision about employees.

Promotion:

Promotion of employees will be shared on the board but the increment never will be shared by the company

Increment is based on financial position of company and competitor’s increment.

Health policy:

Primary test (when new employee join with VerGo Clinicals) Annual medical checkup.

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Protection policies: human resource manager of VerGo Clinicals to be aware of worker protection requirements. This safety equipment are control by engineering department but the policies that what to be installed, where to be installed, when to be installed is HR manger policies.

Fire extinguisher team (monthly training) Safety team (investigation): why this accident happened? First Aid team (nurses and doctors) Fire alarms detectors MCP (manual call point): in each room one MCP button exist. It is used when employee

see the fire then switch this button. Beside this the HR manager do induction when new employee join with VerGo Clinicals,

policy of hiring multiculturalism at work.

Beside this all HR manager do induction when new employee join with VerGo Clinicals, hiring multiculturalism policy, and …

Structure:

Admin executive activities;

Housekeeping management Vehicles management Visitors facilities Laundry inventory

Learning: I learned how they are setting the salaries of the employees, how it runs, how they do the recruiting and selecting of applicant, how they appraise the employee’s performance, how they are managing their activities …

Recommendation:

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HOD

Store executive ll Admin executive

Security Housekeeping Vehicles


Better to use attendance machine for attendance checking to prevent from fraud. Because

the attendance is taken in gate on notebook, when employees come to company and out from company have to sign and write the enter and exist time, so in this case many are interested to do less time work or forget the times writing.

Finance (account) and taxation departments

Finance department is the integral part of organization and control the resources of company. Finance department provides useful information about founds, sources, and company financial positions to others (those who are interested) like CEO, government and… Similarly finance department of VerGo Clinicals control the fund and resources of company.

The main finance department is in Verna so in this case they have meeting every weak and also report to them. Account department of VerGo Clinicals use Projen system for booking the entries because of it is easier for purchase department for booking the GRN (9). Account department can’t pay cash over 20000 Rs per day.

VerGo Clinicals account department use mostly these types of vouchers.

GRN: which come from store department Delivery bills Compensation and salary bills for employees and volunteers

Activities: the main activities of account department is booking the bills to system, making budget, bills …

Control the organization fund. Making budget of organization. Recording all expenditures and income of company Providing the financial information to others (managers, site head, CEO…)

VerGo Clinicals pay those bills first that received first they pay the bills after 30 day that they receive the materials from venders.


9 - goods received note

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Head finance:

Looking after all legal procedure of entries. Monitoring the budget Clarifying the duties

Executives: booking the entries, making bill payment, tax bill payment.

Learning:

In finance department I learned many things like:

How they functioning the department, I understood how they are making the payment. How process of booking GRN is going.

Taxation department Taxation department is also running by finance department, so department structure is same to finance department.

VerGo Clinicals pays direct and indirect tax to government.

Taxation rate on income for VerGo Clinicals

a- Zero to 250,000 not payingb- 250,000 to 500,000 10%c- 500,000 to 1,000,000 20%d- 1,000,000 to - 30%

If company goes in loss government doesn’t give subsidies to company. At the end of every financial year auditors come and check all the expense, incomes, salaries bills payment and balance sheet of company according to this auditors check the profit, income and losses of company then auditors apply the tax.

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head finance

executive l executive ll


Company gives direct and indirect tax to government. Direct tax on income of company which the rate is already explained before. Company also pays indirect tax like service tax.

Besides the direct and indirect tax VerGo Clinicals give the following taxes

Salary tax Wealth tax Service tax Income tax Profit tax

Clarifying the duties is the main job of this department.

Learning:

I learned how the auditors know the income, losses and profits of company and how they are checking the bills.

IT departmentThe main activities of IT department is;

Creating folders for each department on server, each department has just access to their own folders. The characteristic of folders are just read and write.

Controlling the system. Controlling the doors. Each employee has ID card for the doors.

IT department has access to all folders of each department.

Structure of department:

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Softwares which are used by VerGo Clinicals Company;

Name of department softwares

Pathology Patho Plus CR VIMS HR projen ERP DM SAS

Each of these software has the characteristic of only reading and writing. The employees just can read and write but can’t get out the data for the personal use.

Engineering Development (maintenance)Activities:

Installation of equipment Daily routine function checking (daily checking of equipment two times per day once in

morning once in evening). Controlling of;

100KWA for internal system (lights, ACs, cameras and computers) 120 KWA only for LCMS machine

Controlling of generators (380KWA); After 9sec when the electricity go off it become on automatically When electricity comes engineering department change the phase

Installing and Controlling of safety equipment: Smoke detectors Heat detectors Fire alarms Moisture alarms

Every month they are checking these equipment by smoke detector tester

Making permit letters: and looking after the outsiders employees (temporary employees)Permit letters are contains of;

Cold: pumping, AC repairing, carpentry and painting Height: fall celling …

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HOD

Executive lll

Executive l


Electrical isolation: generator Excavation: civil work, digging Confined space: water tank cleaning …

Structure:

Types of fire extinguishers which are used by VerGo Clinicals

ABC: for paper, wooden and fabric burns CO2: for electrical, gas and petroleum burns Clean agent automatic fire extinguisher: when the temperature goes up above 60C0 it

active automatically (only one in archive).

Learning:

I learned how safe working condition is important for company and employees I understood the different types of fire extinguisher especially Clean Agent Automatic

fire extinguisher.

Portor’s forcesPortor’s forces is a framework that attempts to analyze the level of competition within an industry and business strategy development.

The porter five models involves scanning the environment for threats from competitors and identifying problem early on in order to minimize threats imposed by competitors.

1- Rivalry among competitors: wars between firms competing in same industry for gaining customer share to increase revenue and profit.

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site head

electrical manager

executive lll

executive l

https://en.wikipedia.org/wiki/Business_strategy


2- Threat of new entrant: entry of new competitors, more number of new competitors will

make it difficult to exploit the opportunity of new market.

3- Threat of substitute good/service: suppling similar product or service effect on company

4- Bargaining power of buyer/ sponsors: buyers/sponsors also influence on company

5- Bargaining power of suppliers: number of suppliers and the power of suppliers also effect on company.

1- moderate rivalry exist among competitors the reasons can be; A large pharmaceutical companies are capable of carrying out most studies by

themselves. Numerous competitors (they have their own study) Sponsors (buyers) switching costs are high (can’t shift easily)

2- Threat of new entrant: is moderate When new CRO enter to market it needs to have own sponsors and business development divisions in this case the economic barrier become high. Economies barriers just for formulating clinical research is not much, but Pharma

Research and business development is expletory with clinical research. For formulating the whole business the economic barriers become high.

Law and political barriers are less even sometimes government have supportive policies. (less tax than other manufacturing company)

Sponsors (buyers) switching costs are high.

3- Threat of Substitutes is low Though for medicine is no substitutes but for a CRO service still Substitutes exist. Few like pharmacokinetic and pharmacodynamics.

4- Bargaining power of sponsors (buyers) is high: The key factor that has suppressed profitability in the CRO industry is the power of sponsors (buyers). A large pharmaceutical companies are capable of carrying out most studies by themselves. This means if they become dissatisfied with the prices charged by CRO industry they can simply back integrate. Other reason can be there is not too much buyers (sponsors).

5- Bargaining power of supplier is moderate:

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The reason can be if the company want to charge more price on sponsors (buyers) they can shift to next or can improve his CRO organization. But still some companies may not able to do some difficult study by themselves.

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highmoderate

lowmoderate

threat of new

entrant

threat of substitute service

power of sponsors

power of suppliers

Rivalry Moderate


SWOT analysis

SWOT analysis is a powerful technique or strategic planning for identifying strength, weakness, opportunity, and threats your company face. SWOT analysis of VerGo that I did is based on internal and external environments that company face with.

Strengths:

1- Good management team and strong management: good management team with VerGo pharma. Each department have meeting with the members (head with head) of VerGo pharma company once in a week for more better controlling the VerGo corporation coordination companies

2- Pathology center (HIV, HCV and HBSAG testing of volunteers): Besides testing the drugs on human being (volunteers) they are testing the HIV and other types of disease of volunteers for better providing service.

3- Expletory business: the VerGo Clinicals, VerGo pharma and VerGo business development are the expletory of each other it means that they have the CRO, sponsor and business developer. Beside this good co-operation and co-ordination among branches of VerGo Pharma is also the strength of VerGo Clinicals.

Weakness: 1- Small size: small size for more study and has not more branches in other state of India

and outside of India to compete with global CROs

2- Volunteers hesitant: most of volunteer are common people, they don’t have much information about CRO companies though the results of testing is known but they are still not sure to be a volunteer.

3- Difficulty of getting volunteers: less people are interested to be volunteer though the result is known for volunteers even Amed goes outside of Goa for getting volunteers.

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Opportunity: 1- Business growth: day by day pharma companies are producing new drugs and CRO

companies get more opportunity to survive and people also get information about CRO they are also become interested to be volunteers.

2- Economic growth of India: now a days India has fastest economy growth it can be opportunity not only for VerGo Clinicals it can be for all business.

Threat:1- Competitors: the threat for VerGo Clinicals can be competition among competitors

from inside and outside of India.

2- Common people not having proper information about CRO.

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CompetitorsCommon people don't not having proper information about CRO.

Business growthEconomic growth of India

Small sizeVolunteers hesitantDifficulty of getting volunteers

Good management team and strong managementPathology center Expletory business

stenght weakness

threatopportunity


VerGo Pharma Research Pvt. Ltd Company

VerGo Pharma Research Company is a CRO company that manufacture drugs and founded in 2010. VerGo Pharma Company has three branches Business Development, VerGo Pharma Research, VerGo Clinicals.

VerGo Pharma manufacture the different types of drugs (medicines)

Tablets Capsules Liquid Orals Injection Ophthalmic

VerGo Pharma receive the orders from other pharma companies for producing drugs sometimes VerGo Pharma Research formulate their own drugs then those companies which are interested to buy the product of VerGo Pharma are buying the product of VerGo Pharma.

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Purchase department

Purchase department buy chemical materials, machinery, and other materials from different countries and also from some Indian companies.

Suppliers name location what they supply?

KBS Pharma US Innovative samples

Indena Italia API

Segnent Chemical Cop. Pvt. Ltd India chemicals materials

The purchase department receive the materials from the venders by air, car through clearing agents and direct order.

Purchase order process: Purchase department receive requisition from departments than discuss with site head of company. Purchase department do comparing the rates of each company and (fair cost, delivery time, good quality) then make purchase order and send to suppliers.

Basic activities:

Providing (buying) the needs of company Daily contact with departments and assessing the need of departments to avoid

from any shortage of materials.

Comparing the rates of suppliers, evaluating and selecting suppliers. For the purpose of getting the lowest price, less delivery time and good quality

they are evaluating and comparing the suppliers.

Avoiding from shortage of raw materials. To avoid from shortage of materials they have daily contact with departments and

suppliers.

Buying the requisites base on budget and capacity of company. Assessing the capacity and budget of company than buying the requisites. For

assessing the capacity, needs, and budget they have meeting.

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Structure:

Learning:

I learned how they contact with clearing agent and on what bases they select the suppliers.

I learned how this department runs and how they are dealing with venders. I also learned about the suppliers that VerGo Pharma purchase from enteral and external companies.

Manufacturing departmentManufacturing of drugs (medicines) has divided in to many small process. Before they produce the drugs the formulation development department formulate the formula and send for analysis to analytical department, the analysis report goes to Process Technology Department for analyzing for large scale of production. VerGo Pharma manufacturing different types of drugs like tablets, capsules, liquid orals (syrup solution suspension), injection, ophthalmic (eyes solution suspension). In this case each type of drugs has its own process.

Structure:

Process flow chart for tablets:

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HOD

assistant manager

supervisor

operators

HOD

executive III senior executive I


Step1: All the materials are provided by purchase department, in case when they start producing they inform purchase department to provide the needs of them.

Step2: in this step the weight of each ingredient in the mixture is determined according to dose.

Step3: in this step they mix the ingredient with different machine. Mixing the active and inactive ingredient with different machines. The machine is selected according the weight of ingredients.

Step4: In this step they crystalize the powder of ingredients in to grains.

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raw materials

dispensing

mixing

granulation

drying

compression

coating

packing& labeling


Step5: drying is also main step of producing tablets. Different types of dryers are used for drying of tablets.

Step6: the powder directly transferred to compression machine for making tablets. In this step they compress and give shape to tablets

Step7: after giving shape to tablets they do coating for the purpose of covering the unpleasant taste, protection from environment and many other purpose.

Step8: packaging is the final step of manufacturing tablets. They package the tablets and storage the tablets.

Production department tries:

To produce the drugs in safe condition with good quality. To avoid from losses of ingredients and increase productivity. To set up the producing techniques in best manners.

Learning:

I learned how to safe ourselves during producing and how to behave with the employees and member of manufacturing department.

I understood the process of producing tablets and I got basic information about drugs and machine. I learned how they clean the mixers when the producing process is finished.

Formulation Department Formulation development department develop the drug’s formula and stability of drugs.

Formulation Development department formulate the formula and send to analytical department.

Formulation Development department change the ingredients of drugs and make new formula for drugs.

Structure:

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seinor principle scientist

seinor scientist

scientist


Process Technology Transferring department

This department analyzing the process for producing large scale. Formulation development department formulate the formula and send to PTT department. The PTT department make the batches like

Pilot batch (testing how the refection of drug is on human being) VerGo Clinicals do testing the drugs.

Scale up/ process batch: for producing large scale amount they do scale up batch Batch manufacturing: they find out the manufacturing process and send to manufacturing

department Exhibit batch: they send this batch to government for approvals.

Structure:

Learning:

I understood how they improve the process of production for large scale. I understood about batches.

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HOD

seinor scientest

scientest

jienor scientest


Learning: during this summer internship I learned and experienced many thing in VerGo Clinicals which was informative for me and I can say that my experience and learning are more than what I expected I learned and got experience from each departments and I undergo in real work condition. I feel proud to have attained in this internship. I learned about each department how they works and how it function.

BBA learning:

I learned methods of inventory FIFO (first in first out) and LIFO (late in first out).

I learned how they are dealing with venders. I also learned about the suppliers that VerGo Pharma purchase from enteral and external companies.

I learned how they contact with clearing agent and on what bases they select the suppliers.

I learned how to safe ourselves during producing and how to behave with the employees and member of manufacturing department.

I understood how the auditors know the income, losses and profits of company and how they are checking the bills

I understood how they make GRN and how process of booking GRN is going. I learned how they are setting the salaries of the employees, how they do the recruiting

and selecting of applicant, how they appraise the employee’s performance, how they are managing their activities …

I learned how they control the quality, how they looking after the activities of departments. I learned about SOP’s that was new for me. I understood how they are making and how they are controlling the SOP’s, and I learned about CAPA for better control of organization.

As BBA student I did volunteer registration, I learned how to behave with volunteers and how to motivate them to persuade people to become volunteers.

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Scientific learning:

I understood how they improve the process of production for large scale. I understood about batches. I understood the process of producing tablets and I got basic information about drugs and

machine. I learned how they clean the mixers when the producing process is finished. I learned what they are doing on samples, how they register the samples and how they

find the healthy samples. I learned the process of testing the reference and test drugs and randomizations.

General learning:

I learned how safe working condition is important for company and employees I understood the different types of fire extinguisher especially Clean Agent Automatic

fire extinguisher. I learned how they are making consent form and how they are getting evidence from

ethic committee and DCGI for better proof to volunteers that the testing has no side effect.

I learned how to find the elimination time of drugs. I understood that every things in company has special code for better control of

organization. Use of first Aid

Off curse this can’t be only thing that I learned during this summer internship basic thing that I learned how to think, behave like businessman and how to think to create jobs not search a job.

“Try to create a job not to search a job”

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Finding: VerGo Clinicals is only CRO in Goa, day by day human face with new bacteria and virus threats for this reason human need to innovate and develop the drug’s effects. So pharma companies need to CRO more day by day.

I found that volunteers are coming more from outside of Goa than Goan. I found that VerGo pharma Research (Verna), VerGo business development (Mumbai)

and VerGo Clinicals (Corlim) are the expletory company. I found that the CRO market improve day by day.

Suggestion and recommendation: Adding the VR (volunteer service) department to company structure for better providing

information about drugs, procedure, service, and finding of volunteers. Opening of branches outside of Goa for the purpose of getting more volunteers, low

salary for employees and getting more clients.

Limitation of study: Language barrier: the language barrier was limitation for me to study more about

company. Time limitation: 8 weeks for knowing the functioning of each department is not enough. Lack of reliable data: most of them were doctors, nurses and scientist so they couldn’t

give me reliable data from business side Limitation of data.

Methodology: Observation Interaction with staffs, employees, managers and… Questionnaire

Objectives: To use the theoretical knowledge to practical use. To improve our skills. Knowing of functioning each department.

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