Cadila Healthcare Limited (Zydus), a major pharmaceutical company based in India, wanted to develop a “build on and beyond” compliance approach and also launch their eBMR journey. The company sought an MES solution that would improve data integrity, eliminate manual and paper recording and help reduce compliance risk. By implementing PharmaSuite® MES and FactoryTalk® Historian, the company was able to deploy a true end-to-end paperless solution that included ERP and machine integration, role- and risk-based system access, material and equipment identification with barcodes, automatic calculations and structured batch report review processes. Now, Zydus is not only better prepared to meet or exceed regulatory requirements, but they are leveraging MES data orchestration to access analytics and reports on everything from OEE to golden batch in operational excellence efforts.

1. Slide 1

3. Slide 3
API
(Drug Substance)
Finished
Dosage Forms
Wellness Products
Formulation
Development
Packaging
Development
NME Research
Toxicology Studies
(AAA LAC Approved Lab)
CRO
(Clinical Research organization)
NDDS
(New Drug Delivery Systems)
Bottle
Packaging
Vaccines & Biologicals
Pharma Machine manufacturer (Compression machine, Ampoule filling, etc.), HDPE Bottle, Printed Packaging
Zydus
A Fully Integrated Company
New Molecule Entity

4. Slide 4
32 mfg. sites
producing > 19 bn pills
annually
21,000+ employees
across the globe,
with ~1250 for R&D
~ $ 1.5bn
>24% CAGR
In net worth
(FY’15-FY’17)
1st Company
to launch biosimilar
of Adalimumab
Among top 5
pharmaceutical
companies in India
400+ patents
granted worldwide
8 R&D Centers
for NCE, APIs, Generic formulations,
Biosimilars and Vaccines
16 brands
among top 300 brands in
India
~ $ 7.8 bn
market Cap
> 65 years
operational experience
9th largest
generic co. in US in terms
of prescriptions
global revenues
Well integrated pharma player with proven track record

5. Slide 5
• Reduction of risk of non-compliance
– Enforcement of process, material flow, equipment rules, and
quality checks
• Improve data integrity
– Maintain one version of the truth
– Calculations in batch record
– Accurate transcribing of data - paper record, ERP, automation,
scales, log books
• Elimination of paper in manufacturing
• Lengthy batch record review cycles
• Ancillary documentation for batch record
Business / Technical Challenge

6. Slide 6
• Journey began 2 years prior to awarding contract
• Identified a senior leader to do initial research on
MES
• Defined high level user requirements
• Multiple vendor evaluations
• Reference calls and site visits
• Finalized User Requirements
• Detailed vendor audit assessment
• Selected Rockwell Software® PharmaSuite ® due to
best solution fit, domain and technical expertise and
strong local presence
Solution Selection Process

7. Slide 7
• Global leader in industrial automation
• Single platform that offers solutions from Level 0
– Level 4 (ERP integration)
• Flexible and modular framework
• Out of the box integration with automation and
third party systems
• Strong regional presence and partner network
• Implementation partner with extensive expertise
and both local and global experience
Why Rockwell Automation

8. Slide 8
• ERP integration
• LIMS integration
• Automation integration
• Manual intervention reduction
• Production Management
• Material Management
• Equipment Management
• Electronic SOPs
• Real time inventory stock updating to SAP
Functionality achieved by MES

9. Slide 9
• Checks and balances with the system
– manual operator inputs eliminated by 90%
– critical manual inputs signed by authorized personnel
– system checks for expected value violations
– sequence of operation enforcement through interlocks
– role and risk-based system access
– existing CAPA covered in system scope
• Data integrity achieved with
– material identification with barcodes (expected material checks)
– equipment identification with barcodes (expected equipment checks)
– automatic calculations for API materials
– automatic calculations for yield
– weight information reading directly from scales / pre-configured vendor tares
– machine integration (machine setup and run cycle data)
• Completeness in review process
– every deviation (user or system triggered) is captured in batch record
– structured batch report review process
How Compliance was achieved

10. Slide 10
• Decisions on process changes and SOP changes
– acceptance to CHANGE (paper to electronic world)
• Interaction with OEMS and third-party system
vendors
– extracting information related to machine data from OEM
– establishing communication channels on legacy machines
• Integration of multiple systems like MES-BMS-
Historian-OPC from data and time stamp
perspective
– multiple system time stamp synchronization
– matching machine report against historian data
Implementation Challenges

11. Slide 11
• Quality Compliance
– Zero possibility of missing signature or missing entry hence deviations
related to missing entry or signatures eliminated.
– Contemporaneousness due to online data capturing & review.
– All batch related data captured & linked with eBMR.
– Robust and mistake proofing in data logging leading to elimination of
data integrity issues.
– Enhancement in the Right First time BMR score
• Productivity
– Relatively easier & faster documentation procedure.
– Automated update of BMRs lead to lesser manual entries thus
enhancement in manpower productivity.
– Reduced paper work as signature per checkpoint eliminated.
– Automated generation of performance reports e.g. Yield, Cycle time
Snapshot of benefits

12. Slide 12
• Cut over to electronic batch record in January
2017 (paper on glass, no overlap with paper)
• There were initial teething issues but ramped up
steadily in the first few months and achieved
similar efficiency as that of paper for a couple of
months
• After 10 months it was noticed average
efficiency was below efficiency of paper
• W&D efficiency using electronic system was
much better than paper
Post go-live scenario

13. Slide 13
• Conducted detailed study to look at inefficiency in the
system
– Activity flow, operation start and end time, interlocks,
signatures and QA review data
• Identified bottlenecks in each operation that were directly
affecting efficiency
• Changes updated in the process as per study
recommendations
– Parallel QA review, fetch machine data from historian, moved
all SOPS out of master recipe into workflows, removed
interlock of QA signatures
• Recipes running with changes now and will be monitored
for the next few months
• Expect efficiency to be more than that achieved by paper
Steps taken to fix efficiency challenges

14. Slide 14
• Process optimization and process improvement
– process changes within compliance ambit to improve yield
– process standardization
• Analytics and reports
– OEE
– equipment usage / capacity utilization
– productivity
– cycle time
– golden batch
• Overall Manufacturing Operations Management
– other third-party system integration (SAP-PM, Track wise, LMS
etc.)
• Roll out to other plants
Next Steps

15. Slide 15
• In addition to compliance could have leveraged MES
project to optimize operations and improve
processes and remove redundancy caused by paper
• Implemented in a phase wise manner
• Communicate in real time, CAPAs , changes in SOPs
and manufacturing process during project
implementation phase
• Involvement of shop floor operators / supervisors
during recipe design and actual dry runs
• IT team involvement in core team
What would we have done differently

16. Slide 16
• MES is not ERP / DCS / SCADA / Reporting software
• Define clear objectives for implementing the system
• Get out of the paper world – current paper
processes will not exactly match with electronic
processes
• Don’t underestimate the importance of change
management
• Define clear ownership of system during and after
project phase
• Vendor alone is not responsible for MES project
success / failure
Advice to a company in evaluation phase

17. Slide 17
System Architecture

18. Slide 18
Dispensing and Granulation

19. Slide 19
Compression and Coating

20. Slide 20
Inspection

21. Slide 21
Go-live

22. Slide 22
Questions

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