輝瑞制藥公司fmea培訓(xùn)課程教材(英文)(36頁(yè))-質(zhì)量工具(已修改)
2025-08-28 18:27 本頁(yè)面
【正文】 Managing Pharmaceutical Quality: Risk or Uncertainty Management? Ajaz S. Hussain, . Office of Pharmaceutical Science CDER, FDA PQRI Workshop February 1, 2020 What is Quality? ? What is pharmaceutical quality? ? consistent delivery of the label performance and lack of contamination. ? operationalzed via a set of prespecified quality attributes (., specifications, limits) and through the CGMP regulations. ? FDA, in its quality definition, is standing in for the customer—and it is apparent that health care practitioners and patients highly value an additional drug attribute: product availability ? Good pharmaceutical quality represents an acceptably low risk of failing to achieve the desired clinical attributes. Management Goals ? Improving quality and ensuring availability ? Optimal use of our resources ? A systems approach to CMC review and CGMP investigations ? Based on knowledge and process understanding ? Achieving ―quality by design‖ ? Demonstrating ―science of design‖ ? Continuous learning and improvement through ―manufacturing science‖ An Approach for Quality – Risk Connection ? Concept of Quality by Design (QbD) ? Product and process performance characteristics are scientifically designed to meet specific objectives, not merely empirically derived from performance of test batches ? Characteristics important to desired performance must be derived from a bination of prior knowledge and experimental assessment during product development. ? From this knowledge and data, a multivariate model linking product and process measurements and desired attributes may be constructed. ? Clinical study would then be viewed as confirmatory performance testing of the model. Woodcock, 2020 A Systems Approach Science of Design Manufacturing Science Deliver Quality by Design State of Control amp。 Continuous Improvement Quality can not be tested into a product。 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。 toxicological attributes ? Identity ? Complexity ? A range of uncertainty with respect to identity of ―active moiety‖, purity and stability of materials used in evaluation of pharmacological and toxicological attributes (if a mixture。 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。 toxicological response and measurement systems further adds uncertainty Managing Pharmaceutical Quality ? Quality of a drug product ? For establishing proposed therapeutic claim (label) ? Drug product manufactured for clinical trials ? After successful demonstration of therapeutic claim (acceptable risktobenefit ratio) ? Drug product manufactured for mercial distribution ? Life cycle of the product (shelflife, exclusivity period, generic petition, postapproval changes,…) ? Drug product manufactured
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