独立的质量保证体系 Independent Quality Assurance System
独立的质量保证体系 Independent Quality Assurance System

独立的质量保证体系

Independent Quality Assurance System

知识产权保护

IP Protection

项目管理

Project Management
独立的质量保证体系 Independent Quality Assurance System

Independent Quality

Assurance System

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Medleader has established an independent quality assurance system for the four major business platforms of pharmaceutical research, drug safety evaluation research, clinical medicine, and biotechnology. Covering the company's various business areas and projects, from complete quality system documents, to comprehensive personnel training, and strict quality supervision and inspection. At present, the quality assurance system can not only independently perform quality management on the four major business platforms and related content, but also operate jointly to meet the needs of different projects of customers. Through comprehensive internal quality control and quality assurance, the quality of the entire process of project operation is controllable and the compliance of project operation is ensured.

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  • 药学研究质量保证根据自身业务范围与客户需求，结合法律法规，形成了以药品和疫苗管理法为基础，GMP为框架， 药品记录和数据管理要求、生物安全法、药品注册管理办法和药品检查管理办法等等为内容的文件管理体系；
  • 药学质量保证人员通过对文件体系的宣贯培训、检查考核和修订完善，维持质量体系良好运行;
  • 药学研究人员熟知各类研究指导原则，有的放矢，制定详细的研究方案并不断突破完善，优质高效地完成各类研究内容。
  • 自2019年以来，药学研究已为不同客户提供了小试样品、小试工艺、中试工艺交接、质量研究与分析方法转移等等各类交付，均超额完成客户要求。
Pharmaceutical research quality assurance based on its own business scope and customer needs, combined with laws and regulations, has formed a drug and vaccine management law as a basis, GMP as a framework, drug record and data management requirements, biosafety law, drug registration management methods, and drug inspection management Document management system with methods, etc. as content;
Pharmaceutical quality assurance personnel maintain the sound operation of the quality system through publicity, training, inspection, assessment, and revision of the document system;
Pharmaceutical researchers are familiar with the guiding principles of various researches, are targeted, formulate detailed research plans and continue to make breakthroughs and perfections, and complete various research contents with high quality and efficiency.
Since 2019, Pharmaceutical Research has provided various customers with small-scale samples, small-scale process, pilot-scale process transfer, quality research and analysis method transfer, etc., all of which have exceeded customer requirements.
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美莱德药物安全评价研究中心拥有独立的质量保证部门，建立了系统化、标准化的QA检查规范与记录体系， QA对试验方案、试验设施、试验过程、人员资质与能力等各个试验与管理环节进行检查，确保试验研究的规范性。



宗旨

美莱德药物安全评价研究中心秉承客观、严谨、求实的质量理念，遵照NMPA、OECD或FDA的GLP规范、试验方案及SOPs要求独立开展质量监督， 确保安全性试验的GLP依从性，保障试验数据的真实性、完整性和可靠性。

The Drug Safety Evaluation and Research Center has an independent quality assurance department, and has established a systematic and standardized QA inspection specification and recording system. QA conducts various tests and management links such as test schemes, test facilities, test processes, personnel qualifications and capabilities, etc. Carry out inspections to ensure the standardization of experimental research.




Purpose


The Drug Safety Evaluation and Research Center adheres to the objective, rigorous, and realistic quality concept, and independently carries out quality supervision in accordance with the GLP specifications, test protocols and SOPs requirements of NMPA, OECD or FDA to ensure GLP compliance for safety tests and guarantee test data The authenticity, completeness and reliability of the product.

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美莱德临床医学平台基于NMPA、ICH临床试验相关法律、法规及指导原则(GCP）创建质量管理体系， 提供全方位、高覆盖率的质控及稽查服务。通过了ISO9001:2015质量认证，建立了50余项标准操作规程、200多个原始表格， 囊括了方案质量、人员质量、研究中心质量、数据及记录质量、质量保证、临床试验供应质量、药物警戒质量、过程管理及持续提高; 多次通过客户及第三方稽查，NMPA国家局现场核查，保证实验过程中无重大质量问题。



  • 质量管理体系


      • 独立的临床试验质量管理部门
    • 全过程系统化质量监管
    • 各环节标准化操作管理工具
    • 高效质量信息反馈机制
    • 标准化临床试验操作流程
    • 质控与培训一体化管理
  • 质量管理三级质控

Based on NMPA and ICH clinical trial-related laws, regulations and guidelines (GCP), the Merrad clinical medicine platform has established a quality management system to provide comprehensive and high-coverage quality control and audit services. Passed ISO9001:2015 quality certification, established more than 50 standard operating procedures, more than 200 original forms, covering program quality, personnel quality, research center quality, data and record quality, quality assurance, clinical trial supply quality, pharmacovigilance Quality, process management and continuous improvement; repeatedly passed customer and third-party audits, and on-site inspections by the NMPA National Bureau to ensure that there are no major quality problems during the experiment.



Quality Management System


Independent clinical trial quality management department systematizes the whole process of quality supervision, standardized operation management tools in each link, high-efficiency quality information feedback mechanism, standardized clinical trial operation process, integrated management of quality control and training
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美莱德生物分析技术平台依据NMPA、中国合格评定国家认可委员会(CNAS)、FDA颁布的相关法规、准则和指南建立了完整的质量管理体系， 并严格执行和持续改进。取得了CNAS实验室认可证书，并多次通过国家局核查、第三方稽查和客户审计。


生物分析技术平台具有独立的质量保证部，对实验人员、设施设备、计算机系统、试剂耗材、实验方案、分析方法、实验记录、分析报告以及质量控制等进行稽查。 确保运行项目法规依从性，保障试验数据的真实性、完整性和可靠性。

According to the relevant regulations, guidelines and guidelines promulgated by the NMPA, Nakata National Accreditation Service for Conformity Assessment (CNAS), and FDA, the Merrad Bioanalytical Technology Platform has established a complete quality management system, which is strictly implemented and continuously improved. Obtained the CNAS laboratory accreditation certificate, and passed the national bureau inspection, third-party inspection and customer audit many times.


The bioanalysis technology platform has an independent quality assurance department, which conducts inspections of laboratory personnel, facilities and equipment, computer systems, reagents and consumables, experimental programs, analysis methods, experimental records, analysis reports, and quality control. Ensure compliance with operating project regulations and ensure the authenticity, completeness and reliability of test data.