輝瑞制藥公司fmea培訓(xùn)課程教材(英文)(36頁)-質(zhì)量工具-wenkub.com
2025-08-03 18:27 本頁面
【正文】 Quality Assurance Managed under The Company’s Quality System。s lifecycle ? Riskbased approaches inspectional scrutiny。D Control of excipients and other sources of ―mon cause‖ variability Reduce CGMP Risk Classification – Continuous Improvement of Quality System Tactical Online control [Design for Manufacturability] Critical Control Points Robust process endpoint Regulatory Specifications ―Design Space‖ Real –Time Release, Modular Validation Reg. CMC Approval Strategic Science of Design – Design to reduce ―Uncertainty‖ Sci. amp。 Control Specifications Product Design Intended Use Design Requirements Reliability To Deliver Design Requirements Assessment Based on ICH Q8 Information/Knowledge John C Berridge, Q8 Rapporteur (EFPIA). FDA Manufacturing Submittee, July 2020 Knowledge Based Decisions: Require Scientific Generalizeable Knowledge – the ―SUPAC GAP‖ SUPAC Change Levels based on prior knowledge from the pharmaceutical munity (AAPS SUPAC Workshops) + Research。 quality by design is then the prior knowledge and what ever development data is generated (held at site) Uncertainty, Variability and Risk Uncertainty? Variability? Risk? Uncertainty, Variability and Risk ? Procrustean standards have to address ―worst case‖ scenarios ? Uncertainty is not risk, currently we have no choice but to force this equality ? Uncertainty is reduced by improving knowledge ? We learn what to control and the degree of control necessary to minimize risk ? For continuous quality improvement we should focus on improving uncertainty management process Example of a CMC Regulatory Decision: Acceptability of a Post Approval Manufacturing Process Change ? Original NDA or ANDA = CMC Quality 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。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
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