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 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.

Think Pharma will increase

your production efficiency
Deep understanding of your production process
Quality

Integration of quality into process steps

Reduction of quality overhead costs
Performance
Higher production quality, lower production costs

Costs

In bandwidth, self adjusting production processes

Think
ThinkPharma
Pharmaintegrates
integratesquality
qualityinto
intoyour
yourproduction:
production:
Quality
Qualityby
byDesign
Design(QbD)*
(QbD)*
*based on ICH Q 8, 9, 10, GAMP 5, Annex 20 QM

Pharma Process Management

(Present)

discard

Preliminary
product

Checking
(Laboratory)

approve

IPC
checking

Process
Step 1

Process
Step 2

Rework
Process
Step 1
discard

approve

process

locking

Pharma Process Management

(Present)

discard

checking

approve

Step 3

Step 2

Step 1

discard

checking

approve

Time

Cost

Cost

Time

Cost

discard

checking

approve

Time

process

The Goal for QbD Pharma

Process Management (Future)
Step 1 Step 2 Step 3 Step 4

Step 5 Step 6

Process

Inline testing
adaption
direction

Why a Think Pharma Network?

QbD projects are complex and needs different specific knowledge.
Josteit, Herten & Partner
cGxP Compliance
Quality Management

Additional

NIR-Online
NIR-Measurement
& Controlling
Analytical Methods

TP-Core
Network
Microinnova
Micro structured Systems
Process Development &
Engineering

Specialists

Keynes
Production Design
Production Planning
& Realization

Why a Think Pharma Network?

For
ForYou:
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

Think Pharma delivers for

QbD-Projects (overview)
Installation
Installationplanning
planning
Control
Control&&measure
measuretechnology
technology
Micro-process
Micro-processtechnology
technology
Process
Processdesign
design
Basic
Basicengineering
engineering
Information
Informationtechnology
technology
cGxP
cGxPcompliance
compliance

Our understanding of the

pharmaceutical industry needs.
We identified 3 need categories for QbD (key drivers):
C1
C1 Establishing a new production process
C2
C2 Production process change: Up-scaling, outsourcing, standardization
C3
C3 Production process problems; high deficient product
For the 3 categories we identified 3 tool-boxes:
Toolbox
Toolbox

C1
C1 C2
C2 C3
C3

Knowledge Space Mapping (KS)

Design Space Definition (DS)

Control Space Definition (CS)

The QbD-Toolbox
Project Management: CATADIA
Knowledge Space Mapping (KS)
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
Knowledge Space Mapping Report

Toolbox 1
Client SP

CATADIA

NO KE MI

Extract

SP = Special Partner
JH&P = Josteit, Herten & Partner
NO = NIR-Online
KE = Keynes
MI = Microinnova

The QbD-Toolbox
Toolbox 2
Design Space Definition (DS)
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

Client SP

CATADIA

NO KE MI

The QbD-Toolbox
Toolbox 3
Control Space Definition (CS)
Client SP
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

CATADIA

NO KE MI

ALL

TP proven industry values

Competences
Competences
Process

Plant

Measurement

Validation

Experiences
Experiences
Fields
Fields

Chemical, Petro, Food, Pharma, Automotive, Bio Fuels,

Content
Content

Automation, R&D, CGxP, Planning, Construction,

Micro Reactor Technologies, , Project Management

Clients
Clients

BASF, Roche, Novartis, Grnenthal, ADM, Bayer,

Schering, Degussa, Umicore, IMA,

Contact
You can reach us for more information and detail discussion:
Dieter E. Herten
Geschftsfhrer
CATADIA Consulting GmbH
Jentgesallee 11
47799 Krefeld
Phone: +49-21 51-15 18 00-1
E-Mail: dieter.herten@catadia.com
WEB: www.think-pharma.de or www.quality-by-design.de

QbD Easy Example : My best Coffee quality

Coffee Quality 1

Coffee Quality 2

Coffee
Quality
not
accepted

Coffee Quality 3

The mill knows exactly

My QbD Coffee Mill

what Coffee quality I

want (consistency, taste,
temperature, cup filling quantity)

This coffee is always

perfect as I like it.