Quality by Design Course Preview
- 1. Quality by Design Course Name : Quality by Design Version : INVL_QBD_CW_01_1.0 Course ID :QMGT- 168
- 2. 2 About Invensis Learning Invensis Learning is a pioneer in providing globally-recognized certification training courses for individuals and enterprises worldwide. Our training methodology coupled with high-quality courseware has enabled organizations to achieve high-impact learning with increased knowledge, competence, and performance. We offer courses in various categories such as IT Service Management, Project Management, IT Security and Governance, Quality Management, Agile Project Management, DevOps, and Cloud Courses. Invensis Learning certification training programs adhere to global standards such as PMI, TUV SUD, AXELOS, ISACA, DevOps Institute, EXIN, and PEOPLECERT.
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- 4. 4 “Live as if you were to die tomorrow. Learn as if you were to live forever.” - Mahatma Gandhi
- 5. 5 Agenda Introduction Some history and scene setting Relationship of QbD to ICH guidelines Overview and definition of QbD Design space Control strategy
- 6. 6 Quality by Design – The Origins Quality by Design – coined by J M Juran (1904-2008) - pioneer and evangelist for quality management techniques. The Juran Trilogy - Quality Planning - Quality Control - Quality Improvement Statistical approach owes more to W Edwards Deming (and others) “Cease dependence on inspection to achieve quality. Build quality into the product in the first place.” “There is no substitute for knowledge." "Experience by itself teaches nothing."
- 7. 7 History QbD techniques were adopted in many industries from 1970’s onwards, particularly automotive and electronics. Quality planning principles are enshrined in the ISO9001 and ISO13485 for design and manufacturing processes. Recent usage of the term stems from adoption by FDA for modernisation of review and approval process pharmaceutical and biotechnology products. ICH*– developed a new set of guidelines for pharmaceutical development *ICH = International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
- 8. 8 ICH Guidelines The ICH Vision as Described in Guidelines A New Quality Paradigm Science and risk-based approaches to pharmaceutical product development, dossier submission, review, inspection and post-approval change management Manufacturers empowered to effect continuous improvement and technical innovation throughout the product lifecycle Efficient and consistent regulatory oversight across/between regions
- 9. 9 Q. Where should QbD be applied? A. To all elements of a drug or biotechnology product Pharmaceutical Product Formulation Device components Container Closure System Drug Delivery System Drug Substance Excipientsform Supply chain
- 10. 10 ICH Guideline Q8 defines QbD as… A systematic approach to development that begins with predefined objectives & emphasizes product and process understanding and process control, based on sound science & quality risk management ..and Quality as the degree to which properties of a product, system or process fulfil requirements 7
- 11. 11 What is QbD? Quality by Design is…. A scientific, risk based proactive approach to pharmaceutical product development A deliberate and structured design effort from first stages of conception and innovation through the full product life cycle A complete understanding of how product attributes and process parameters relate to product performance.
- 12. 12 Product development – definitions General approach Quality Target Product Profile - - - - Use and market related target requirements Related to safety and efficacy Intended use, dosage form, dosage strength Quality criteria - sterility, purity, stability, etc. Critical Quality Attribute - - Physical, chemical, biological property Should be within a defined range to ensure product quality Related to materials, intermediates, final product. - Critical Process Parameter - Parameter whose variability has an impact on a CQA - Should therefore be monitored or controlled 9 Define control strategy Define CPP of manufacturing process Identify CQA - components Identify CQA - product Define QTPP
- 13. 13 Product development – minimum and QbD approach “Quality by Design” Systematically understand and refine the product and process Risk assessment Knowledge Experimen t Minimalist approach Quality target product profile Identify material attributes and process parameters that affect CQAs and the functional relationships between them Establish control strategy e.g. design space e.g. real-time release testing Critical quality attributes Critical process parameters Continual improvement Reduced variability Innovation Define control strategy Define CPP of manufacturing process Identify CQA - components Identify CQA - product Define QTPP
- 14. 14 Stage-gated device design processes Risk management Usability evaluation LaunchStage 4: Detailed design & output creation Stage 7: Scale up & transfer to manufacture Stage 1: Requirements definition & capture Stage 2: Concept creation & selection Stage 3: Design input definition Stage 5: Design verification Stage 6: Design validation Produce First tooling Launch Late stage development Early stage development Full development Discovery Produce Pre-clinical evaluation Phase 3 clinical evaluation
- 15. 15 Medical device stage gated device design process Systematic analysis & experimentation Risk management Usability evaluation Launch Stage 4: Detailed design & output creation Stage 7: Scale up & transfer to manufacture Stage 1: Requirements definition & capture Stage 2: Concept creation & selection Stage 3: Design input definition Stage 5: Design verification Stage 6: Design validation Produce First tooling Design verification Process validation Design transfer Design planning Design inputs Design outputs Design validation Change control Design space definition Control strategy QTPP CQA CPP? CPP Systematic analysis & experimentation Experience gained in production Prior knowledge
- 16. 16 Design space ICH 8 defines design space as: The multidimensional combination and interaction of input variables and process parameters that have been demonstrated to provide assurance of quality. For example: Scientific investigation – Experience? - Design of experiment? - Analytical model? - Process validation? Injection moulded medical device Knowledge of design space Assembly process Injection mould process Mould tools Component drawings (with tolerances) Polymer specifications
- 17. 17 Design Space Comments on Design Space Can a Design Space ever be complete? - Yes, if all parameters with a potential effect are investigated in all combinations. In other words – Not really. - Risk management is needed to ensure itsrobustness of the Design Space Design Space does not need to go to the edge of failure – useful to know, but not mandatory Set of proven acceptable ranges is not a Design Space Design space should be verified at each scale of manufacture.
- 18. 18 Steps in development of a process Design Space - Internal knowledge from similar products and processes External knowledge – peer reviewed publications, etc. Define QTPP - Define CQA Use prior knowledge to understand variables and their impact Process risk - Modelling may be OK, but needs full verification and justification - Based on knowledge plus additional tests where needed Iterative as experience is gained. assessment to identify CPPs - Conduct and evaluate DoE to establish CPP/CQA relationshipsRepeat as necessary
- 19. 19 Analysis of variation Can we analyse the relative contributions of the identified CPP and CQA to variability or failure of the device? Theoretical Tolerance analysis Sensitivity analysis Theoretical modelling of mechanisms Finite element analysis Experimental Single factor experiments Designed experiments for multi-factor analysis Validation/ verification studies Design space
- 20. 20 Control strategy Control strategy Needs to ensure that required quality is produced consistently and is assured by combination of: In-process control and measurements Upstream process controls Input material controls Must be based on understanding of CPPs and the impact of variability. Can enable adaptive process steps that vary according to input materials. Can ultimately lead to real time release testing. Control strategy
- 21. 21 Summary QbD is recommended for 21st century pharmaceutical development – and by extension to Container Closure Systems QbD has less impact on MedTech product development processes since the requirements are close to good design and manufacturing practices. QbD requires profound understanding of effects of, and interactions between, materials, products and process parameters. QbD leads to a more flexible manufacturing environment, responsive to upstream variability CCS and drug delivery system component suppliers need to prepare to share information with pharmaceutical clients.
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