輝瑞質(zhì)量風(fēng)險管理-展示頁
2024-08-20 17:17本頁面
【正文】 d uniformity tests, ….. SOP’s,….. Current Demand Management: Characteristics ? For conventional products and manufacturing processes easy to implement, supervise, and mange ? Decision responsibility is deferred to a set of ―procrustean‖ standards liability distributed to the entire pharmaceutical munity (., via USP, AAPS, etc.) ? For innovative and/or plex products and processes no one is willing to take responsibility for decisions (., develop guidance document) – decision liability is then on the person willing to take a decision. Current Demand Management: Characteristics ? Innovation and continuous improvement slows down and inefficiency increases ? The level of quality assurance achieved is difficult to measure and is buried in historical mindset and clinical variability ? With increasing plexity a major failure is necessary to signal inadequacies of the system – such a failure is often the only approach to introduce new regulations or improved decision criteria ? Challenge to and alternate approaches to current procrustean standards difficult to prove and debates drain resources Without Continuous (Community) Learning: Demand Management is “static” until a crisis is created, it then reacts to replace a current procrustean standard with another. Continuous Improvement: Enhancing Customer Satisfaction Reducing Variability ―Special Cause‖ or ―Common Cause‖ Stable Yes。s Process Validation and Quality System Deviations, Out of Specifications,... ANDA Applications: Limited Information Content (., IR Capsule) ? Generally 1biobatch ? Bioequivalence goal post 80125% ? 90 % Confidence Interval for the Test/Reference ratio for Cmax and AUC in between the goal post ? Normal healthy subjects, crossover design, fasting (and fed) conditions ? Common for all oral drugs – ., procrustean ? To cover ―worst case‖ scenarios ? If mean is 100% and 90% CI is outside 80 125 say 85 ? ? Executed batch record and master batch record (., 10X) – application mitment ? Postapproval process validation and stability mitment ? Post approval changes based on SUPACIR Demonstration of ―quality by design‖? ? Analytical data + Executed batch record + biostudy + process validation ? IQ, OQ, PQ,.. ? PQ = 3 consecutive batches in conformance ? Reduced testing – ., pendial tests ? For simple, conventional product designs works fine most of the time。 variability adds additional uncertainty) ? Variability in the extent and rate of delivery of ―active moiety‖ to the sites of action and variability in the pharmacological amp。 it has to be by design “Market Standards” Science of Design + Manufacturing Science = Quality by Design Risk/Benefit and Quality Harm Acceptable Risk/Benefit Quality Label No benefit (placebo effect) Managing Pharmaceutical Quality ? Quality of a new molecular entity (a potential drug) ? Intrinsic pharmacological amp。Managing Pharmaceutical Quality: Risk or Uncertainty Management? Ajaz S. Hussain, . Office of Pharmaceutical Science CDER, FDA PQRI Workshop February 1, 2022 What is Quality? ? What is pharmaceutical quality? ? consistent delivery of the label performan
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