【正文】 ontinuous improvement of product quality ? 5% preapproval ? 95% Postapproval 26 Formal Experimental Design (DOE) Conformance/ Validation Studies PostApproval Propose Product Life Cycle Evaluation Identify (Critical/ Key Attributes/ Parameters) Confirm (Control/ Predict) Monitor (CAPA Continuous Improvement Innovation) Risk Assessment/ Mitigation Comparability Protocol Risk Assessment/ Mitigation CGMP Adherence PAT PAT 27 Quality System ICH Q10 Concepts Commercial Manufacturing “The pharmaceutical quality system should assure that the desired product quality is routinely met, suitable process performance is achieved, the set of controls are appropriate, improvement opportunities are identified and evaluated, and the body of knowledge is continually expanded” 28 Quality System – Deviations amp。 recognize the value of quality system ? Strong mitment on producing safe and effective product decision to release or reject of batch justified by data and science (responsibility of QA) ? Clear munication and promotion from top management on importance of quality to all employees and units of operation ? Implementation and enforcement on quality system 24 Pharmaceutical Quality System Lifecycle Approach ? Process performance and product quality monitoring system。1 Ensuring Drug Quality for Public Health The Implementation Brenda Uratani, . Assistant Country Director FDA China Office, Beijing 2 Overview ? Challenges to Globalization of Drug Manufacturing ? FDA’s Work in China ? GMP Principles: Issues of the most concern 3 Challenges ? Significant demand in resources for inspections ? Consequences of globalization, including more foreign manufacturing and clinical trials sites ? Greater plexity associated with manufacturing ? FDA concern about the state of industry pliance and insufficient investment in manufacturing and quality systems 4 FDA International Efforts FDA Overseas Efforts LongTerm Goal ? Products ing to the . meet .