PHARMA 4.0 AND LIMS -...
Transcript of PHARMA 4.0 AND LIMS -...
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What is Pharma 4.0
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Industry 4.0 as the convergence of people, physical systems, and datawithin an industrial process to increase quality, productivity and profit by using the power of advanced data analytics.
Pharma 4.0 can be defined in the same way
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What’s driving pharma towards Pharma 4.0?
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Meeting GMP Regulations
• Continuous Product Monitoring
• In past, annual product quality review is not necessarily ideal
• But now, there is a growing expectation for manufacturers to perform review more than annually
• Careful Control of Operation to produce critical medicines
Competition
• The demand of high drug quality
• Prolong the shorter drug life cycle
• Reduce high cost of batch manufacturing
• The needs of providing more personalized therapies
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1. Cost of upgrading legacy systems but this
can be quickly offset by tangible results:
higher productivity and reduction in
downtime and waste.
2. Finding adequately skilled manpower with
advanced skill sets such as advanced
analytical skills.
3. A lot of islands information will be another
concern – To completely reap the benefits of
Pharma 4.0, it would mean to connect
hundreds and thousands of devices such as
sensors, machines and network with each
connection to be a potential point of
interest. To effectively mitigate this risk,
companies will need to build data lake and
have to become more open to investing in
skilled cyber-security personnel.
Challenges in Pharma 4.0
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Pharma 4.0 Operating Model
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ISPE’s Pharma 4.0 Special Interest Group (SIG) has developed an operating model for moving from Industry 4.0 to Pharma 4.0 which is shown in the image below
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Pharma 4.0 Operating Model
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InLIMS is in one of the Pharma 4.0’s operating model element (Information Systems).
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What is InLims?
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Designed specially for
Pharmaceutical
Adhere to CFR 21 Part 11
guidelines
Adhere to Good Manufacturing
Practices (GMP)
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InLims Business Values
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Gain data visibility
Remove error in lab operation
Enhance quality
process
Enhance regulatory
compliance
Increase lab
productivity
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InLims Modules
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inLIMSMaster
Management
Samples Registration
Samples Conditioning
Result Management
Reports
Dashboard / Analytics
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InLims Modules
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inLIMSMaster
Management
Samples Registration
Samples Conditioning
Result Management
Reports
Dashboard / Analytics
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Master Management
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Master Management
Testing Type
GC, HPLC, Micro etc
Parameters
Chemical
Kadar
KeseragamanKandungan
Disolusi
Physical
Ketebalan
Kekerasan
Waktu Rapuh
Visual
Tablet
Capsule
Syrup
Suspension
Products
Spec / Control Limit
Parameters To Be Tested
Manual / Direct
Integration
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InLims Modules
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inLIMSMaster
Management
Samples Registration
Samples Conditioning
Result Management
Reports
Dashboard / Analytics
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Samples Registration
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Samples Registration is one of the main modules in InLims to register the lab samples for testing.
Key Features:
Batch Number
Translation
Conditioning Requirements
Lab Test Requirements
Barcode Generation
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Samples Registration
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Barcode Label
The barcode label is highly customized based on customer requirement.It can be designed in QR code or UCP barcode.
The barcode label will be used to stick into the physical lab samples.
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InLims Modules
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inLIMSMaster
Management
Samples Registration
Samples Conditioning
Result Management
Reports
Dashboard / Analytics
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Conditioning
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Conditioning Duration Record
Conditioning Reminder
Stop Conditioning
Samples Conditioning is one of the required modules in InLims if you want to do stability test on the lab samples.
Key features:
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InLims Modules
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inLIMSMaster
Management
Samples Registration
Samples Conditioning
Result Management
Reports
Dashboard / Analytics
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Result Management
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Input Result
• Entry lab test result for:
• Chemical
• Physical
• Visual
• Formula for following chemical parameters have been digitize:
• Content Determination
• Content Uniformity
• Dissolution
QA/QC
• Highlight result based on the spec/control limit
Approval Workflow
• 2 approval level:
• Lab Supervisor
• Lab Manager
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InLims Modules
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inLIMSMaster
Management
Samples Registration
Samples Conditioning
Result Management
Reports
Dashboard / Analytics
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Report
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Samples Registration
Report
Published Report
COA Report
Trend ReportAnnual Product
Review Report
E-signature is available in the system and will be printed in the reports.
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InLims Modules
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inLIMSMaster
Management
Samples Registration
Samples Conditioning
Result Management
Reports
Dashboard / Analytics
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Assessment Model for Pharma 4.0
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Vision
People
Organisation
Programs and Methods
Performance Driving System
Business Operational Excellence
Factory Strategic Plan
MISSION
VOLUMES
PRODUCTS
ECOSYSTEM
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Workshops for Pharma 4.0
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Industry 4.0 Mini Series
(2 days)
• To understand key concepts of Lean
• How Lean related to industry 4.0
Implementing Lean Six Sigma
(3 days)
• Understand Lean Six - Sigma
• Apply Six-Sigma methodology
• Identify opportunities for process improvement
• Know the synergy between Lean and Six Sigma
• Benefits of Lean Six-Sigma
Industry 4.0 Readiness Assessment
(1 day)
• To understand your readiness before moving to Industry 4.0