↓ costs increased efficiency for production of products and development of new products.

• Process owner and main driver is CMC part of R&D
• Bears majority of costs for QbD especially during early phases with high attrition rates (increased R&D expenditure and fixed capital for hardware & software tools)
• Defines QTPP, CQAs, CMAs, CPPs, Design Space and initial Control Strategy

• Improved drug products with superior efficacy, safety and compliance
• More reliable planning of deliverables (e.g. for clinical supplies, transfer to operations)
• More predictable timelines and success rates during development phases (mainly for CMC activities, but also GLP toxicity and clinical outcome)
• More capable processes for transfer to production
• Design Space supports continual improvement and regulatory flexibility

↑ utility consistently producing reliable quality

• Participates in QTPP, risk assessment and Control Strategy
• Hand shake with R&D at transfer, i.e. = process owner thereafter
• Uses Design Space
• Applies Knowledge Management, Continual Improvement, Continuous Process Verification

• Higher yields, less OOS or batch rejections
• Opportunity to increase process capability and riding down the experience curve faster
• Higher inventory turnover due to improved planning reliability
• Improved contribution margin
• Reliable product supply for marketing

• “Voice of the customer” in contributing to QTPP, CQAs and risk assessments
• Part of Knowledge Management and Continual Improvement during product lifecycle

• Increased customer satisfaction or even delight by higher value proposition for all customers (patients, health care providers, health authorities and health care systems)
• More pricing options (more for much more applicable if patient benefits significantly from the new drug product)
• Increased customer equity

↓ costs less recalls, less filing of variations, and complaints; increased flexibility

• Regulatory Affairs and Quality Assurance act as customer service units
• Continuous participation and involvement in QbD activities throughout product lifecycle
• Implementation and maintenance of PQS and QRM as enablers for QbD
• Major stakes in validation verification and Continual Improvement
• QA has oversight over quality of development
• Regulatory affairs is interface to regulatory flexibility

• Increased customer satisfaction or even delight by higher value proposition for health authorities and health care providers
• Increased efficiency for production by obtained regulatory flexibility (Design Space)
• Lower costs for testing (RTRT) and release of drug products

• Incentives to promote adoption of and contribution to QbD
• Provide relevant people skill sets

• Lower costs for QbD, development and production through improved efficiency of people
• Sustainability of achievements through motivation and workforce satisfaction

• IT systems integrating multitude of isolated systems into corporate structure; this facilitates risk assessment and enables superior Knowledge Management and Continual Improvement
• Integration of suppliers and contract manufacturing partners into QbD approach

• Smooth transfer between stakeholders
• Improved data acquisition and evaluation throughout lifecycle
• Extraction of relevant data rather than multitude of information (enabler for Minimalism approach)

• QbD affects entire supply chain from sourcing of raw materials, manufacturing of intermediates and final products, testing and release to distribution of products to all customers
• Ensuring CQAs and integration of information throughout supply chain into Knowledge Management and Continual Improvement

• Lower COGS through sourcing and distribution of materials in compliance with QRM and Design Space flexibility
• Increased material turnover and resulting capital turnover rates
• Benefitting from increased efficiency via applicability of JIT

• They need to be fully integrated into the QbD approach
• Harmonised QbD approach and tools at supplier level and all outsourcing partners are ideal
• Joint QRM and risk assessments during development and throughout product lifecycle are essential
• Suppliers’ CQAs for the raw materials translate into material attributes for the drug product’s CQAs

• Reduced costs from raw materials or batch rejections help to improve contribution margin
• Improved efficiency from reliable planning for supply and use of JIT approach
• Superior value proposition from excellence can be achieved if reliable quality is provided for the complete supply chain
• Increased flexibility and sustainable processes to lower overall COGS

• Top management has an essential role to play in cascading the leadership and direction to senior management of the individual departments, so that the required changes can be integrated throughout all organizational processes.
• “Improving PPD through QbD is primarily about execution, not approving higher levels of R&D investment.” “Delegating the task exclusively to the front line will not work.”⁵⁵

• Reduced timelines and costs for development and production of new products increase rate of innovation and competitive advantage
• Improved efficiency and contribution margin increase gross margin and return on sales
• Moving to the value creation frontier as a differentiator or cost leader and sustaining its position by becoming a broad differentiator
• Improved customer satisfaction and customer equity increases market share and profit growth
• Increased profitability of the company and shareholder value