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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
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
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
Zydus CADILA, 2011 Page 4
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
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.
Zydus CADILA, 2011 Page 5
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
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
Zydus CADILA, 2011 Page 6
START
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
[NO] [NO] D
[YES] [YES]
[NO]
[YES]
[NO]
Zydus CADILA, 2011 Page 7
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
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
[YES]
[NO]
[YES]
Zydus CADILA, 2011 Page 8
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)
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
[NO]
[YES]
Notifications: A Single line segment highlights the direct communication between two end Hierarchy .
Arrow highlights Hierarchy.
Line indicates link between two People.
Zydus CADILA, 2011 Page 9
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
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
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>>
Zydus CADILA, 2011 Page 10
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
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>>
Zydus CADILA, 2011 Page 11
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
Goods Delivery Manager Goods Delivery Management
<<responsible>>
Verification analyst Final Process Analysis
4.Organisation Model(Flow Diagram)4.Organisation Model(Process View)
Zydus CADILA, 2011 Page 12
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
Zydus CADILA, 2011 Page 13
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
5. Process View (5.1 Data Flow Diagram 0 level) Plant(Location+ NA/NOC Title clear certificate) Details
Dealing Details Authorized Approval
Zydus CADILA, 2011 Page 14
Indian Drug Authority
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
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
Zydus CADILA, 2011 Page 15
0
Zydus Cadila(Medicine Manufacturing
to Implementation of
Export)
Chair Person
USFDA /ANDI
Plant Director
0Plant Project Schedule
Plant Director
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
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
Zydus CADILA, 2011 Page 16
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
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
Cur Exc Details C_Ex_Mas
5.2 Business Process Model
Plan to make USFDA Approval
Zydus CADILA, 2011 Page 17
Select Product For Approval
Make manufacturing of Product
Leased ProcessAnalysis
BANK / RBI
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
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
Zydus CADILA, 2011 Page 18
Batch Validation Analysis
Trial & Error Analysis
Make Proper Documentation along with Experimental Report
Pass to USFDA
Export is Approval
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
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.
Zydus CADILA, 2011 Page 19
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
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)
Zydus CADILA, 2011 Page 20
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
Mr. Harish Sadana (Sr. Vice President- Finance) Mr. Jagdishchandra Mistri (Ex. GM-Zydus Cadila)
Zydus CADILA, 2011 Page 21