苏州智享承诺向客户及患者提供卓越品质的服务及产品，在研发和GMP生产过程中按照“质量源于设计”的理念来制定科学、安全、合规的质量控制策略，并参照ICH Q8，Q9，Q10设计公司质量管理体系，以保障质量活动满足早期IND申报和后期BLA的申报要求。
IntellectiveBio promises to provide the excellent service and product to our clients and patients. We follow the concept of “Quality by Design (QbD)”, based on the quality strategy with science, safety and regulatory compliance, to develop the process and analytical method during the process development and GMP production. According to ICH Q8, Q9, Q10 to design the quality management system of IntellectiveBio, it guarantees that the quality meets the requirement of IND filing for early clinical phase and BLA for late clinical phase.
智享质量管理体系（QMS）涵盖了药品全生命周期所需的质量管理活动，通过持续的监控、回顾、定期更新来不断完善质量管理体系，并保证高效运行，以确保我们所提供的产品和服务，及其相关活动的质量。
The IntellectiveBio Quality Management System (QMS) of IntellectiveBio covers the quality management activities for the entire lifecycle of pharmaceutical products. Through continuous monitoring, review and regular updates to continuously improve and efficiently operate the QMS to ensure the products and service related activities quality.
苏州智享设有符合中美双报要求的大分子药物质量控制平台，符合GMP对不同临床阶段试验样品生产的要求，我们按照ICH Q9“质量风险管理”的策略对原料和辅料进行质量检测，严格按照GMP要求对产品原液和成品进行放行检测和稳定性研究。
IntellectiveBio has the quality control platform for macromolecular drugs that meets the requirements at IND/BLA stages for the China and US. The platform meets the GMP requirement of the clinical sample production at different clinical phases. We examine raw materials and excipients according to the ICH Q9 "Quality Risk Management". The release testing and the stability study of drug substance and drug product are conducted with GMP.
智享质量控制平台以合规性为首要目标，确保数据均符合数据可靠性的要求。
Regulatory compliance is the priority in IntellectiveBio quality control platform to ensure data meets the data integrity.
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质量控制平台以合规性为首要目标，确保数据均符合数据可靠性的要求。
Regulatory compliance is the priority in IntellectiveBio quality control platform to ensure data meets the data integrity.
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实验室数据可靠性管理，确保电子数据和纸质数据均能满足“ALCOA+”的要求。
Data integrity management ensures that both e-data and paper data meet the requirement of "ALCOA +".
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标准操作规程包括仪器、试剂、实验方法、系统适应性、数据分析、接受标准、审核和批准等要求。
Standard operating procedure(SOP) content includes instruments, reagents, methods, system suitability, data analysis, acceptance criteria, review and approval.
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按照ICH Q2(R1) Validation of Analytical Procedures: Text and
Methodology与各国药监单位要求进行分析方法确认与验证
Design and execute the method validation with the concept of ICH Q2 (R1) “Validation of Analytical Procedures: Text and Methodology” and the guideline of regulatory unit.
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无效试验（Invalid assay）和超标（OOS）管理规程
SOP of Invalid assay and OOS management
苏州智享质量管理体系（QMS）涵盖了药品全生命周期所需的质量管理活动，通过持续的监控、回顾、定期更新来不断完善质量管理体系，并保证高效运行，以确保我们所提供的产品和服务，及其相关活动的质量。
The IntellectiveBio Quality Management System (QMS) of IntellectiveBio covers the quality management activities for the entire lifecycle of pharmaceutical products. Through continuous monitoring, review and regular updates to continuously improve and efficiently operate the QMS to ensure the products and service-related activities quality.