Let us make your process predictive!. Key Pharma Market Aspects The global market for Pharma is...
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Let us make your process predictive!
Transcript of Let us make your process predictive!. Key Pharma Market Aspects The global market for Pharma is...
Let us make your process predictive!
Key Pharma Market Aspects
The global market for Pharma is rapidly changing and evolving.
The increasing regulation decreases product profitabilitypreference for GenericsCost cutting & budgetingIncrease of purchasing powerhigh 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.
Think Pharma will increase your production efficiency
Quality
Performance
Costs
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)*
Think Pharma integrates quality into your production: Quality – by – Design (QbD)*
*based on ICH Q 8, 9, 10, GAMP 5, Annex 20 QM
Pharma Process Management (Present)
process
Preliminary product
Process Step 1
Checking(Laboratory) approvediscard
IPCchecking approve
locking
Process Step 2
discard
ReworkProcess Step 1
Pharma Process Management (Present)
Time
Cost
Time
Cost
Time
Cost process
Step 1 Step 2 Step 3
checkingdiscard approve checkingdiscard approve checkingdiscard approve
The Goal for QbD Pharma Process Management (Future)
Step 1 Step 2 Step 4 Step 5 Step 6Step 3
Inline testing
adaption
Process
direction
Why a Think Pharma Network?
QbD projects are complex and needs different specific knowledge.
TP-Core Network
Additional
Specialists
Josteit, Herten & PartnercGxP ComplianceQuality Management
NIR-OnlineNIR-Measurement & ControllingAnalytical Methods
MicroinnovaMicro structured SystemsProcess Development &Engineering
KeynesProduction DesignProduction Planning & Realization
Why a Think Pharma Network?
For You:For You:
A cross-pollinated solutiongiven 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
Think Pharma delivers for QbD-Projects (overview)
Installation planning
Control & measure technology
Micro-process technology
Process design
Basic engineering
Information technology
cGxP compliance
Installation planning
Control & measure technology
Micro-process technology
Process design
Basic engineering
Information technology
cGxP compliance
Our understanding of thepharmaceutical industry needs.
We identified 3 need categories for QbD (key drivers):
Establishing a new production process
Production process change: Up-scaling, outsourcing, standardization
Production process problems; high deficient product
C1C1
C2C2
C3C3
For the 3 categories we identified 3 tool-boxes…:
Toolbox C1 C2 C3Toolbox C1 C2 C3
Knowledge Space Mapping (KS)
Design Space Definition (DS)
Control Space Definition (CS)
X
X
X
X
X X
The QbD-Toolbox
Knowledge Space Mapping (KS) SP CATADIA NO KE MI
Customer objective definitionQbD 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
Toolbox 1
Knowledge Space Mapping Report
Project Management: CATADIA
SP = Special PartnerJH&P = Josteit, Herten & PartnerNO = NIR-OnlineKE = KeynesMI = Microinnova
Client
Extract
The QbD-Toolbox
Design Space Definition (DS) SP CATADIA 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
Toolbox 2
Design Specification
Client
Control Space Definition (CS) SP CATADIA NO KE MI
Toolbox 3
The QbD-Toolbox
Development of approximate specified scenario
Conservative (PO) or Radical approach (QbD)
Qualification/Validation
Composition/Conception Technical Design, …
Development
Piloting
Realisation
Reorganisation
Training
Client Final Acceptance
ALL
Client
TP proven industry values
CompetencesCompetences
Process Plant Measurement Validation …
ExperiencesExperiences
Fields Fields
Clients Clients
Chemical, Petro, Food, Pharma, Automotive, Bio Fuels, …
ContentContent Automation, R&D, CGxP, Planning, Construction, Micro Reactor Technologies, …, Project Management
BASF, Roche, Novartis, Grünenthal, ADM, Bayer, Schering, Degussa, Umicore, IMA, …
Contact
You can reach us for more information and detail discussion:
Dieter E. HertenGeschäftsführer
CATADIA Consulting GmbHJentgesallee 1147799 Krefeld
Phone: +49-21 51-15 18 00-1 E-Mail: [email protected]: www.think-pharma.de or www.quality-by-design.de
QbD Easy Example : My best Coffee quality
The mill knows exactly
what Coffee quality I want (consistency, taste,temperature, cup filling quantity)
Coffee Quality 1 Coffee Quality 2 Coffee Quality 3
My QbD Coffee Mill
This coffee is always perfect as I like it.
CoffeeQuality
not accepted
