List of Figures
List of Tables
List of Abbreviations and Definitions
1. The Challenges in the Pharmaceutical Industry and Arising Opportunities
1.1. More for more, the same for more or less for more – is there still a choice?
1.2. The dilemma of R&D in the pharmaceutical industry
1.3. Quality by Design – the authorities’ initiative to improve the science in NDAs and the quality of drug products
1.4. Further guidance and support to facilitate the implementation of QbD
1.5. The current status of submissions and work sharing programs in the USA and Europe
1.6. The changing focus in the attempts to demonstrate the value proposition of QbD fort he pharmaceutical industry
2. QbD in the Pharmaceutical Industry: a Shift of Paradigms
2.1. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use guidelines aiming to improve the quality of drug products
2.2. FDA’s continous validation guideline supporting QbD
2.3. Are Six Sigma, Lean Six Sigma, Design for Six Sigma, TQM and QbD just using the same tools o rare they pursuing similar objectives?
2.4. So how does QbD differ from these other approaches, if at all?
3. „Less is Better“ as a Distinctive Competency Providing Value Innovation and a Competitive Advantage
3.1. Minimalism Strategy
3.2. Objective: Generating a competetive advantage in combining QbD with a „less is better“ approach
3.3. Strategies for the roll out of QbD and their advantages and disadvantages
4. QbD as a Distinctive Competency Providing a Competetive Advantage and Sustainable Profitability for a Pharmaceutical Organisation
4.1. Generating core customer value via product quality and price
4.2. The implications and benefits of QbD for the value chain
4.3. Linking QbD to the St. Galler Model of Integrated Management
4.4. QbD aiming to minimize variability in R&D suces rates
4.5. Combining QbD with a „less is better“ Minimalism approach
4.6. The perspective for the business model and ist competitive advantage für profit growth and a sustainable profitability
5. Elements of QbD in a Drug Application of a Branded Generic – the First Steps at Pharma Example Ltd
5.1. Establishing QbD as a Design for Six Sigma approach
5.2. A streamlined, systematic development approach of branded generics
5.2.1. Project Target Profile for the development of clarithromycin pellets for administration with the SIP® technology
5.2.2. Critical Quality Attributes for Product Score Cards
5.2.3. Prototyping and selection of formulation and process og ClaroSip® taste masked pellets
5.2.4. Control strategy
5.3. The benefits during development and marketing authorisation
5.4. The lack of integration backfiring during commercial production
6. The Roll Out of QbD at Pharma Example Ltd. – a Stepwise Approach
6.1. Generating a business case for QbD from candidate nomination onwards 66
6.1.1. The state of quality
6.1.2. Vision and mission
6.1.3. SWOT analysis
6.1.4. Organisational structure: champion approach and team matrix
6.1.5. Milestone plan for the roll out
6.1.6. Costs of implementation: It’s not for free but it’s worth it
6.2. Stepwise roll out of a new concept
6.3. Integration of the supply chain into the QbD approach
6.4. The long term perspectives for a comprehensive PQS serving both, drug development and design & development of medicinal devices
6.5. The early benefits for development after implementation of the first steps
6.5.1. Shift of development focus from product performance and customer needs
6.5.2. QbD improves quality of drug products and overall project quality
6.5.3. Streamlining of project times facilitated by QbD
7. Investigation on the Roll Out of QbD in the Pharmaceutical Industry and the Pursued Objectives
7.1. Questionnaire to obtain feedback about the current status, reasons for and benefits out of ObD implementation in the pharmaceutical industry
7.2. Analysis and discussion of the state of the roll out of QbD in the pharmaceutical industry
7.2.1. For which products and from which phase on has QbD been established?
7.2.2. Which functions are the initiators and stakeholders of the QbD roll out?
7.2.3. Alignment of QbD with TQM and Six Sigma projects in production?
7.2.4. QbD Integrated Supply Chain?
7.3. The intentions behind the roll out?
7.3.1. Experiences gathered to date with QbD?
7.3.2. Can QbD increase profitability and/or sustain profit growth?
7.3.3. Experiences gathered to date with QbD?
7.4. Is there a return on investment (ROI) for QbD
7.4.1. Measuring ROI
7.4.2. Why is QbD still not fulfilling ist full potential, producing significant return on investment
8. Can QbD Foster the Industry’s Search for Better Medicines and a Sustainable Profit Growth?
8.1. McKinsey’s business case for QbD
8.2. McKinsey’s description of obstacles to the widespread implementation of QbD
8.3. The future focus of the FDA to promote QbD
8.4. Minimalism and a real industry business case as an alternative promotion for QbD
9. Appendix: Web Based Questionnaires Posted at www.zoomerang.com
9.1. Questionnaire for invitation to surcey by direct mailing
9.2. Questionnaire for invitation to surcey on LinkedIn
9.3. Invitation to participate in survey started on LinkedIn
References and Websites