凯莱英生物严格按照中国GMP、FDA cGMP、EMA及ICH相关法规指南要求，依托凯莱英医药集团享有盛誉的质量管理体系，结合生物药大分子特性，全面建立了国际化的生物制药质量管理体系。该体系符合美国、欧盟和中国GMP[JZ1] 的管理要求，用以开发和生产满足高质量标准的人用药品。
凯莱英生物质量管理体系涵盖厂房和设施系统、物料系统、生产系统、质量控制系统、包装和标签系统以及质量保证系统。
凯莱英生物质量管理体系文件分四级：质量手册、生物板块通用性程序、工厂程序（包括管理规程、操作规程和技术程序）和记录表单等。
1. International Quality Management System
In accordance with NMPA GMP, FDA cGMP, EMA and ICH regulations and guidelines, based on the successful experiences from Asymchem Corporate quality system, and combined with the biologics characteristics, AsymBio has established a comprehensive quality management system in compliance with US, EU and China GMP requirements.
AsymBio quality system covers six systems: Facilities and Utilities Systems, Materials Systems, Production systems, Quality Control Systems, Packaging and Labeling Systems, and Quality Assurance Systems. The Quality System documents are designed with four levels: Quality manual, AsymBio General Procedures, Site procedure including Standard Management Procedures, Standard Operating Procedures and Standard Technical Procedures, and Record/Label/Form/Protocol/Report.
2. Project Quality Management
In order to be in compliance with the regulatory requirements at different phases of new biologics development [antibody drug, antibody drug conjugated (ADC)] to meet client expectation, AsymBio has established Risk Control Strategies to manage the different phases in the biologics lifecycle from preclinical to commercialization, to ensure compliance requirements, in the meantime to control entire project timeline and cost to satisfy clients’expectations.
从工艺技术转移、工艺验证 (PPQ)、细胞库、原液和制剂的质量控制与放行、以及产品最终关键质量属性（CQA）的确定和制造及检定规程的申报批准，凯莱英生物从各个环节保障客户药品上市后的安全性、合规性和有效性。
3. Quality by Design and Risk Control
In order for the successful BLA submission when the projects entering the late phase, AsymBio implements ICH Q10 quality management system guidelines, utilizes the concept of ”Quality by Design”, and corporates the ICH Q9 risk management tool to monitor and manage the entire drug product lifecycle from development to commercial production and market launching.
By focusing on Process Technical Transfer, Process Performance Qualification (PPQ) , quality control and release of cell banks, drug substance and drug product, establishing critical quality attributes, regulatory submission and approval of manufacturing and testing procedure, AsymBio ensures the safety, compliance, and effectiveness for supplying biologics for the clients.
质量体系运行和项目生产执行过程中，凯莱英通过变更控制、偏差管理、内部审计、纠正和预防措施以及培训等工具，保证产品质量以及提高管理团队的合规意识，科学正确处理生产过程出现的异常，降低项目的合规风险，为项目保驾护航。
4.Compliance Management and Continuous Improvement
In order for the continuous improvement of the AsymBio quality system,AsymBio team implements GAP analysis on the quality system after new or revised regulations or guidelines are published from regulatory agencies such as FDA，EMA and NMPA, etc.
During the daily operation and production, AsymBio utilizes quality tools such as change control, deviation management, internal audit, corrective and preventive action, and training, etc., to ensure the product quality and enhance the team of compliance knowledge, in order to scientifically-sound investigate and handle abnormalities in the production process, as well as reduce the project compliance risk to safeguard the project.
