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Let us make your process predictive!
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Key Pharma Market Aspects
The global market for Pharma is rapidly changing
and evolving. The increasing regulation
decreases product profitability preference for
Generics Cost cutting budgeting Increase of
purchasing power high PAI drug development
risks costs The complexity costs of quality
administration on top of production costs are
high and increase (IPC, QA, QM). New production
technologies and measurement methods are
available.
The cost of drug production incl. quality plays a
more significant role.
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Think Pharma will increase your production
efficiency
Deep understanding of your production
process Integration of quality into process
steps Reduction of quality overhead
costs Higher production quality, lower
production costs In bandwidth, self adjusting
production processes
Think Pharma integrates quality into your
production Quality by Design (QbD)
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QbD Easy Example My best Coffee quality
Coffee Quality 2
Coffee Quality 1
Coffee Quality 3
Coffee Quality not accepted
The mill knows exactly what Coffee quality I
want (consistence, taste, temperature, cup
filling quantity)
My QbD Coffee Mill
This coffee is perfect as I like it.
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Pharma Process Management (Present)
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Pharma Process Management (Present)
Time
Cost
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The Goal for QbD Pharma Process Management
(Future)
process
Inline testing
adaption
direction
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Why a Think Pharma Network?
QbD projects are complex and needs different
specific knowledge.
Josteit, Herten Partner cGxP Compliance Quality
Management
NIR-Online NIR-Measurement Controlling Analytic
al Methods
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Why a Think Pharma Network?
For You
A cross-pollinated solution given by the combined
knowledge and experience of the TP Core
Network Practically founded and proven process
solutions adopted to the specific needs of the
pharmaceutical industry Benefits of experience
from other closely related industry
processes Short and precise advice,
planning, implementation and qualification
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Think Pharma delivers for QbD-Projects (overview)
Installation planning Control measure
technology Micro-process technology Process
design Basic engineering Information
technology cGxP compliance
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Our understanding of thepharmaceutical industry
needs.
We identified 3 need categories for
QbD Establishing a new production
process Production process change Up-scaling,
outsourcing, standardization Production process
problems high deficient product
C1
C2
C3
For the 3 categories we identified 3 tool-boxes
Toolbox C1 C2 C3
X
Knowledge Space Definition (KS)
X
Design Space Definition (DS)
X
Control Space Definition (CS)
X
X
X
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The QbD-Toolbox
Project Management JHP
Toolbox 1
Knowledge Space Mapping (KS)
SP
JHP
NO
KE
MI
Customer objective definition QbD relevant
development/organisational interfaces Development
Knowledge Base Chemical/physical
identities Product composition and
formulation Production processes
technology Reference model/ benchmarking R D
process Analytical process assessment
(actual) Process key data
SP Special Partner JHP Josteit, Herten
Partner NO NIR-Online KE Keynes MI
Microinnova
Knowledge Space Mapping Report
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The QbD-Toolbox
Toolbox 2
Design Space Definition (DS)
SP
JHP
NO
KE
MI
Risk analysis Determination of Critical Process
Parameters (CPP) and Critical Control Points
(CCP) Definition of the verification of CCP as
well as development of the corrective actions
Design Specification
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The QbD-Toolbox
Toolbox 3
Control Space Definition (CS)
SP
JHP
NO
KE
MI
Development of approximate specified scenario
Conservative (PO) Radical approach
(QbD) Qualification/Validation Composition/Concept
ion Technical Design, Development Piloting Real
isation Reorganisation Training
ALL
Final Acceptance
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TP proven industry values
Competences
Process Plant Measurement Validation
Experiences
Chemical, Petro, Food, Pharma, Automotive, Bio
Fuels,
Fields
Automation, RD, CGxP, Planning, Construction,
Micro Reactor Technologies, , Project
Management
Content
BASF, Roche, Novartis, Grünenthal, ADM, Bayer,
Schering, Degussa, Umicore, IMA,
Clients
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Contact
You can reach us for more information and detail
discussion
Dieter E. Herten Geschäftsführer Josteit, Herten
Partner Consulting GmbH Bahnhofstr. 315 D-47447
Moers Phone [phone] or -0 Mobile
Phone [phone] E-Mail
dieter.herten_at_jhp-consulting.de WEB
www.think-pharma.de or www.quality-by-design.de
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