Business Process Modeling Case Study

2011

CASE STUDY

AKASH GAJJAR / 09MCA011 / [email protected]

Submitted to: Mrs. Priyanka Shah

Remark:

CADILA HEALTHCARE LIMITED (ZYDUS GROUP)

Manufacturing to Implementation Process of Medicines

Version 1.0

‘’Here the case study is related to Pharmaceutical Business, aim of this case study is to focus on manufacturing process of Medicines, including various Tests applied yielding

validation to approval of authority, by whom you are explicitly exports your products to a particular country via a chain route of diverse activities involving it. And all such is described

via Diagrammatic as well as Mainline Process view ’’BY TAKING A REAL WORLD SCENARIO

Manufacturing to Implementation Process of Medicines Version: 1.0Showing Business Process with help of various Diagrams Date: 2nd April-2011

AKASH GAJJAR(09MCA011) / SEMESTER-IV / CICA / CHARUSAT /ECC

ReVision document HistoryDate Version Description Author

28th Feb-2011 1.0 Analyze overall Process Understanding

Akash Gajjar

9th March-2011 1.0 Mainline of the Business Process Akash Gajjar

12th March-2011 1.0 Organization Chart / Structure

References include; Main Process Flow Chart

Akash Gajjar

13th March-2011 1.0 Flow Diagram Akash Gajjar

1st April-2011 1.0 Business Process Reengineering, Business Process Automation

Akash Gajjar

2nd April-2011 1.0 Responsibility View, DFDs Akash Gajjar

2nd April-2011 1.0 Main Process View, Finalized the Documentation

Akash Gajjar

Zydus CADILA, 2011 Page 3



Table of Contents1.Mainline Business Processes (6)

2.Main Process Flowchart (7)

3.Organization Chart / Structure (10)

4. Organisation Model

4.1 Defining Roles (Responsibility View) (11)

4.2 Flow Diagram (12)

4.3 Process View (13)

5. Process Model

5.1 Data Flow Diagram

5.1.1 Data Flow Diagram (0 Level) (14)

5.1.2 Data Flow Diagram (1 Level) (15)

5.2 Business Process Model

6. Process Reengineering

6.1 Which Process? How?

7. Process Automation

7.1 Which Process

How ?

8. References




A short Description of various Terminologies used in CASE STUDY

Here below defined terminology may not be the exactly written to the particular terminology, but mainly shows idea of which they semantics on workflow.

1) API: An acronym of Active Pharmaceutical Ingredeince, a heart of any medicine affecting a living body.

2) ANDI: Advance Novel Drug Application, a type of approval for Pharmaceutical business for manufacturing a particular product.(Here Medicine)

3) Batch: A standard of doing workflow for medicines which further makes validation for approval.

4) Bulk Drug: A substance which has marked physiological effect when taken onto the body.

5) Custom Warehouse: A central government authorized place where goods are kept before they export to a particular country. The aim of such management is to privilege excise duty.

6) Excise Duty: A tax levied on domestically produced goods at the production stage, and such duties are administrated by local authorities & the Customs and Excise authorities.

7) Export: Send (goods or services) to another country.

8) Foreign Exchange Regulation Act: It is one kind of process by which trade of one currency to another. This takes place on the international exchange markets where trading sets the exchange rate of currencies.

9) Raw Material: A basic material from which a product is made.

10)Stock: A supply of goods or material available for sale or use.

11)Test: Involving all leading kind of Tests like Starch (Biological Terminology) Test, Raw Material Test for making a Medicine Batch.

12)USFDA: An acronym of United States of Food &Drug Authority, main body governed by US, which makes feasibility study in order to approval for export of medicines to their country. N.B.: For a particular country there must be a unique authority.

13)Validation Batch: A report made by manufacturing authority involving all the factors like storage location ,temperature acquire, self life, on which machine it is tested, with proper documentation in order to get approval.

14)VAT: Value Added Tax. A method of taxation of goods and services whereby tax is levied on the extra contribution to the value of a goods or service rendered through a business operation.




1. Mainline of the Business Process As the Company is related to Pharmaceutical B’ness, so main focus is manufacturing of medicines, vaccines & other human health products & providing wealth in terms of healthcare with intensive care of human via professional interconnection with Business. Indian Drug Authority License for manufacturing in India.

Fundamental start Process including Raw Material, APIs,etc.

Batch Validation Approval Animal & Human Experiment Analysis (Hard Copy in terms of Test Analysis) All kinds of other tests like Starch Test (as explained earlier) Generation of Report with proper documentation which contains data analysis Carried away with exact day, date and time along with temperature acquired. ANDI Approval USFDA Approval (Here United States of America, as another company has Different choice under certain circumstances. Approval is finalized to Export.

Plan & make execution to Export

Third Party Contract include negotiating terms & conditions.

Excise Duty Payment from out warding to Custom Warehouse

RBI & Bank (to which A/C is concerned) transaction for Foreign Exchange

Payment is done.

Here a whole cycle of approximately measurable time of one & half to two years is successfully completed.

2. Main Process Flowchart


START



[NO] [NO] D

[YES] [YES]

[NO]

[YES]

[NO]


Take

Permission

from Indian

Drug

Authority

Decisi

on

Process goes to

Manufacturing

in Plant

Retry to

make

Permissio

n

Area , NA /NOC Title

Clear Certificates &

other necessary

details

Decisi

on

As per Govt act

Wait until

renewing License

Period has been

expired.

STOP

Acquiring Raw

Material for

medicines as well as

packing

Purchasing or Producing Raw

material for

Medicines/Vaccines

While Purchasing ,

contains Negotiating

terms under certain

Period.

Tests / Starch Test for

Further cyclic Process

Making of API along

with Previous Case

Checking

for

ApprovalCycle goes to

Animal / Human

Test A

A

Checking

for

Approval

Process is

recycled.

Details of Raw

Material, Bulk Drugs,

Plant

Machinery ,Details of

Plant land



[YES]

[NO]

[YES]


Experimental analysis

Frequent

analysis of

Experimen

t

(Trial &

Error )

Checking

for

Approval

Batch Process

is Approved

Medicine/ Vaccine

is ready for

market use

Goes for

Packing

Including

Complete

Cartage Box

Stores in

Company’s

Warehouse

Expiry Date, Date of

Manufacturing, Temperature

Acquired Date of Cartage

Packing, Serial

Number, Weight,

Message that how to

Handle Box

STOP

Plan to make for Export

with Successful Approval

ANDI

Approval

Mission for

Company

visit via

USFDA

A

AIndustry(Whole

Manufacturing Plant)

Analysis by

USFDA

Plant Details, Machinery Details, Bulk Drug

Details, Animal Test & Human Test intervention

details; Date, Day & Time wise details, Report

Analysis with Graphical Representation, Export

Dealing Terms, Current Position of market

ratio ,Practical well improved Material showing

color movements (An approximately 120-200

pages of whole)



[NO]

[YES]

Notifications: A Single line segment highlights the direct communication between two end Hierarchy .

Arrow highlights Hierarchy.

Line indicates link between two People.


License

Approval for

export

Plan for Export in

USA

Negotiating

Terms

Goods

(here

medicine)

goes to

Custom

Warehouse

Excise Duty

Payment

Third party Dealing

(Bank to Bank Currency

Transfer)

RBI

Concerned for

Currency

Exchange

Identifying

erroneous in

Profile

Complete

Analysis

Goods are going to

shipping/Cargo

Compartment

(Based on Dealing)

Simultaneously

Currency is

transferred &

goods are

delivered to

Particular

Type of Company’s

A/C ,To which Bank

Details

Export Details,

Approx time for

Delivery of

Goods

Whole process for

Export

completation

Analysis

STOP



3.Organization Chart / Structure

Chairperson (Main Body) ANDI {Manufacturing}

Indian Drug Authority Plant Director

Plant Machinery and Miscellaneous Resources USFDA

Authority

Batch Validation Authority

Bulk API & Human Batch Drug Experiment Maker

Authority Tester Leased Process Analyst Special House {Documentation} Volunteer Keeping Staff Goods Apparatus Export Provider Planner

Clean And HR/Communication

Garbage Manager Department {Govt activities concerned}

Senior Accountant

{Excise/ Warehouse Work Verification}

Goods Delivery Transport Manager Report Maker

Verification Analyst

4.Organization Model (4.1 Defining Roles/ Responsibility View)

<< responsible>>

<<responsible>>




ANDI App Plan <<responsible>> R&D Mgt Chairperson <<hierarchy>>

<<responsible>> USFDA Approval Plng <<hierarchy>>

Plant Mgt Plant Director

<<responsible>>

<<hierarchy>> Main Authority Resource Mgt (All types of Resources) <<hierarchy>> <<hierarchy>> <<hierarchy>>

Batch Validator

Bulk API /Human Test Batch Drug Tester Authority Member

<<responsible>>

<<responsibility>> <<responsibility>> <<responsibility>>

<<hierarchy>> Batch Val_Mgt Bulk_D_Mgt API_Test_Mgt B_Mgt

<<responsibility>>

DOS_P_Mgt

Leased Process Analyst <<hierarchy>> Deliv_Mgt Exc_Wa_Mgt <<responsible>> <<responsible>> <<hierarchy>> <<responsible>> Export <<hierarchy>> Planner

Exp_Mgt HR Manager (Govt. Concerned) SR. Accountant

N.B. After Hierarchy with SR. Accountant (Contd. From above Page..)

<<responsible>>




Goods Delivery Manager Goods Delivery Management

<<responsible>>

Verification analyst Final Process Analysis

4.Organisation Model(Flow Diagram)4.Organisation Model(Process View)







5. Process View (5.1 Data Flow Diagram 0 level) Plant(Location+ NA/NOC Title clear certificate) Details

Dealing Details Authorized Approval


Indian Drug Authority



Details

Company Details

Plant Details

Manufacturing Process Details

Project Plan Details

Export [ Manufacturing Plant + Location + Approval Product manufactured + Details Machinery +All types of Resources] details [Negotiating +Dealing] Details

Process Plan Details

5.Process View (5.2 Data Flow Diagram 1 Level)

Plant Details Project detailstPlant P_D_Mas


0

Zydus Cadila(Medicine Manufacturing

to Implementation of

Export)

Chair Person

USFDA /ANDI

Plant Director

0Plant Project Schedule

Plant Director



Machinery acquire

Details Machinery detailsP_M_Mas

All type of

Testing Details Bulk Drug Result Details B_D_MasBulk DrugDetails

T_Mas

Testing Details

Batch Validation

Details B_V_Mas

Plant Details Batch V_Detais

Testing Details

All req Details E_D_Mas

E

Export Dealing details Doc Details

Ex_P_Mas

Dealing Details


1Plant M Providance

2Bulk Drug Providence

3Testing

4Batch Validate

Plant MachineryAuthority

Bulk DrugAuthority

Testing Authority

Batch Validation Authority

5Export Approval USFDA / ANDI

6Export to Country

Export Authority

7CurrencyExchange Details



Cur Exc Details C_Ex_Mas

5.2 Business Process Model

Plan to make USFDA Approval


Select Product For Approval

Make manufacturing of Product

Leased ProcessAnalysis

BANK / RBI



Plan to Make USFDA Approval Finalize the Product

All the Details of

Plant, Manufacturing

Machine Details with

Proper Schedule

Yes

Export to USA NO

6. Process Reengineering

As far as M&C is concerned, where all trades, export process required frequent Analysis of all kind of Processes (also sub processes) actively involved, and on account of Contemporary factors like quality, service, speed, cost concerned. REENGINEERING will eventually becomes part of re improvement of the whole.

Here as mentioned to the above “Export of Medicines to the particular


Batch Validation Analysis

Trial & Error Analysis

Make Proper Documentation along with Experimental Report

Pass to USFDA

Export is Approval



Country” Acquire Reengineering.

Now How you are applying Reengineering ? Selection of the Export approval process Key Processes. 1)USFDA Approval = Whole Process Workflow + Documentation + Batch Report.

2)Bank A/C Transfer Management3)Third party Deal

Proper understanding Desire work flow of USFDA Approval. Appoint Dedicated Team Members for particular product to be manufactured yielding Approval. Do procure analysis in terms of maximum raw material cost deduction, if possible step up For own raw material manufacturing so that processing time has been so manipulated. Establish internationally approved benchmarking for critical factor measurement of Batch Validation Process. Do trusted agreement with outside third party throughout Business Relationship. With maximum time utilization for excise duty payment, nevertheless warehousing to Transportation becomes faster(At any cost !!!). In this way , goods are received by third party whole process is reengineered.

7. Process Automation

Here for this Product Project “Batch Validation (Manufacturing (Initialization) to Of Medicines(Final Batch Approval))” acquire Automation.Company has to Perform following Steps: 1)Planning to make manufacturing of “Medicine Raw Material” in a Company so that time Of gaining process has been reduced.




2)Establish self measurable activities for Raw Material Process, API Test along with Computerized machine analysis.

3)Well organized Animal Warehouse, which facilitate all requirement for Medical Tests.

4)Benchmarking test analysis with minimum time led solution, yet another then cost Utilization has been procured. Also keep in mind that “Better than never the late”

5)In this way step up process led to success !!!

8. References

Annual Report of Zydus Cadila 2009-10 Corporate Office Team Mr. Mukesh Savai (GM-Purchase Dept)




Mr. Harish Sadana (Sr. Vice President- Finance) Mr. Jagdishchandra Mistri (Ex. GM-Zydus Cadila)


Business Process Modeling Case Study

Technology