1. Let us make your process predictive!

2. 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.

3. 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

4. Pharma Process Management (Present) process Preliminary product Process Step 1 Checking (Laboratory) approve discard IPC checking approve locking Process Step 2 discard Rework Process Step 1

5. Pharma Process Management (Present) Time Cost Time Cost Time Cost process Step 1 Step 2 Step 3 checking discard approve checking discard approve checking discard approve

6. The Goal for QbD Pharma Process Management (Future) Step 1 Step 2 Step 4 Step 5 Step 6 Step 3 Inline testing adaption Process direction

7. Why a Think Pharma Network? QbD projects are complex and needs different specific knowledge. TP-Core Network Additional Specialists Josteit, Herten & Partner cGxP Compliance Quality Management NIR-Online NIR-Measurement & Controlling Analytical Methods Microinnova Micro structured Systems Process Development & Engineering Keynes Production Design Production Planning & Realization

8. 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

9. 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

10. Our understanding of the pharmaceutical 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 C1 C2 C3 For the 3 categories we identified 3 tool-boxes…: Toolbox C1 C2 C3 Knowledge Space Mapping (KS) Design Space Definition (DS) Control Space Definition (CS) X X X X X X

11. The QbD-Toolbox Knowledge Space Mapping (KS) SP CATADIA NOKEMI 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 Toolbox 1 Knowledge Space Mapping Report Project Management: CATADIA SP = Special Partner JH&P = Josteit, Herten & Partner NO = NIR-Online KE = Keynes MI = Microinnova Client Extract

12. The QbD-Toolbox Design Space Definition (DS) SP CATADIA NOKEMI 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

13. Control Space Definition (CS) SP CATADIA NOKEMI 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

14. TP proven industry values Competences ProcessPlantMeasurement Validation … Experiences Fields Clients Chemical, Petro, Food, Pharma, Automotive, Bio Fuels, … Content Automation, R&D, CGxP, Planning, Construction, Micro Reactor Technologies, …, Project Management BASF, Roche, Novartis, Grünenthal, ADM, Bayer, Schering, Degussa, Umicore, IMA, …

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

16. 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. Coffee Quality not accepted