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Engineer Forward
Principal [email protected]
David Daniel
A Systems Approach to Transforming the Pharmaceutical Manufacturing Chain
2© 2015 Casewise - confidential
Solution OverviewHolistic Model to Drive Optimization and Innovation
IndustryStandards
PATFramework
System EngineeringPrinciples
ValidationStandards
Discover, Plan, Control and Implement Innovation in
Pharmaceutical Manufacturing
Corporate Insight
OperationalData
Industry Best Practices
3© 2015 Casewise - confidential
Other Terms:
• Good Automated Manufacturing Practice (GAMP)Set of guidelines for manufacturers and users of automated systems in the pharmaceutical industryThe Good Automated Manufacturing Practice Guide for Validation of Automated Systems in Pharmaceutical Manufacture describes principles and procedures to help ensure pharmaceutical products have the required quality.
Key Terms and StandardsBuilding Blocks for the Complete Analytic Solution
Process Analytic Technology (PAT) is an FDA approved framework to design, analyze, and control pharmaceutical manufacturing processes through the measurement of Critical Process Parameters (CPP) which affect Critical Quality Attributes (CQA).*
ANSI/ISA-95 is an international standard for developing interfaces between enterprise and control systems. (ISA-88 is a related control standard)
* Adopted widely throughout the global pharmaceutical industry
4© 2015 Casewise - confidential
FDA’s Call To Action and InnovationDocument Lays Out the Roadmap for the Future
PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurancehttp://www.fda.gov/downloads/Drugs/.../Guidances/ucm070305.pdf
Recognizes the need for innovative thought, through engineering, to improve the pharmaceutical industry
Lays the foundation for method in product process engineering (i.e. manufacturing)
Sets the stage for holistic engineering from supply chain to manufacturing to distribution.
Ties process engineering to requirements management.
Ties holistic systems engineering to the risk-based approach of manufacturing.
5© 2015 Casewise - confidential
Initial Transformation Reduces RiskDivide Risk Across the Entire Manufacturing Lifecycle
Raw Materials Process/Manufacture Batch Testing Distribution
“Traditional”Manufacturing Process
Risk
Cost
Time
Raw Materials Process/ManufactureTest Test Distribution
PAT (Inline)Manufacturing Process
Risk
Cost
Time
6© 2015 Casewise - confidential
ISA-95 OverviewHolistic View Optimizes Vertically and Horizontally
Enterprise
Site/Plant Site/Plant Site/Plant
Area Area Area
Batc
h
Batc
h
Conti
nuou
s
Conti
nuou
s
Dis
crete
Dis
crete
Area Area Area
Batc
h
Con
tin
uou
s
Conti
nuou
s
Conti
nuou
s
Batc
h
Dis
crete
Area Area Area
Batc
h
Batc
h
Batc
h
Conti
nuou
s
Dis
crete
Dis
creteLe
vels
0 –
4
(+2
)
Enterprise
Work Site
Work Area
Work Center
Work Unit
Work Equipment
Work Asset
0
1
2
3
4
(1)
(2)
Business Planning and Logistics
Manufacturing and Operations Control
Batc
hC
ontr
ol
Con
tin
uou
sC
ontr
ol
Dis
crete
Contr
ol
ISA-88 Controls
Level Data
Span of Control
7© 2015 Casewise - confidential
One Common ViewCasewise Captures All Aspects of the Business in a Unified Repository
Standards, Principles and Best Practices
Business
Process
Technology
Data
RequirementsPerformersOrganization
Strategy
External
Systems
Resources
Capital and Operational Planning
Capability
Infrastructure
Network
8© 2015 Casewise - confidential
Model to CapabilitiesUnique Configurations of Process, Actions, Resources, and People
Capability One
Process1
Process2
Process3
TestX
TestY
Capability Two
ProcessA
ProcessB
ProcessC
TestAlpha
TestBeta
9© 2015 Casewise - confidential
Capabilities Control and Optimize ProcessOperational Optimization Drives Efficient Use of Resources
Raw Materials Process/ManufactureTest Test Distribution
PAT (Inline)Manufacturing Process
Risk
Cost
Time
Capabilities Available to Combine and Recombine
Raw Materials Process/ManufactureTest Test Distribution
OptimizedManufacturing Process
Risk
Cost
Time
10© 2015 Casewise - confidential
Engineered InnovationBuilding Blocks for the Science of Innovation
= Optimized Process/Existing Product
± = Improved Process/Product
+ = New Process/Products
+ = Innovative Process/Products
Underpinning Analysis
Standards BasedManufacturing Controls
SoundSystems Engineering
AuditableResults
Strategic Alignment
Organizational Change Management
Resource Management
Product Portfolio Management
