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Regulary Ases Pru Develmen ICH Press Q, Q, Q资料
World Health Organization * * World Health Organization * * World Health Organization * * World Health Organization * * World Health Organization * * Pharmaceutical Development To design a quality product and its manufacturing process to deliver the intended performance of the product To provide scientific understanding to support the establishment of design, specifications and manufacturing Product development studies form a basis of quality risk management Pharmaceutical Development Quality cannot be tested in the product; it should be built in by design Design space proposed by applicant is subject to regulatory assessment and working within the space is not a change Movement out of design space is considered to be a change and requires post-approval change process Pharmaceutical Development Critical aspect of drug substances, excipients, container closure system and manufacturing process should be determined Opportunities exist to develop more flexible regulatory approach, e.g. Risk-based regulatory decisions Process improvement within the approved design space without further regulatory review Reduction in post-approval submissions Real time quality control, leading to a reduction of end product testing Q8: Pharmaceutical Development PathsCurrent Understanding at ICH API Dosage Forms For small large molecules Traditional (basic) pharmaceutical development Enhanced (QbD) In-depth understanding of process Design Space Process Validation Quality by Design Summary The quality of drug substances and drug products is defined by their design, development, in-process controls, process validation, and by specifications applied to them throughout the development and manufacture With the use of mathematics and statistical approaches, the DOE will prove theoretical critical control points in a process Optimum yield, reduce variation, build robustness in the product and process requires Design of Experiment Quality by Design Summary (cont’d) Optimization of product
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