2. Resources
  3. Quality Management System

Quality Management System

High-quality products with comprehensive testing
Professional team-based quality management
All-encompassing support, centered on customer needs
MCE Quality Analysis Platform

6,000 m2+

Independent Laboratory

400+

Technical Team

300+

Precision Instruments

GRLP / GMP / CNAS

Operational System

11,000+

Customer Support

Quality Management System

Organizational Management and Leadership Role

  • •  Organizational structure
  • •  The role of leadership in quality management
  • •  Personnel qualifications and training management
  • •  Resource and facility management

Product Management

  • •  Customer demand management
  • •  Product classification
  • •  Information research
  • •  Custom product design and development
  • •  Product documentation and technical data management
  • •  After-sales service management
  • •  Product change management

R&D Management

  • •  Material supplier management
  • •  Material procurement management
  • •  Warehousing and batch management
  • •  Laboratory information management system

Quality Control and Improvement

  • •  Calibration and maintenance of instruments and equipment
  • •  Product testing and release
  • •  Packaging and storage management
  • •  Batch management and traceability
  • •  Quality monitoring and analysis
  • •  Nonconformance management
  • •  Customer complaints and product recall handling
  • •  Continuous improvement planning
Enforcement Standards

We are committed to the ISO 9001:2015 international standard as one of our core guiding principles. Strictly integrating and adhering to ISO 9001 standards throughout, this well recognized quality management system ensures the quality of our product from production to delivery. Additionally, certifications like ISO 17025 and cGMP not only validate our quality management capabilities but also drive our continuous improvement efforts, establishing MCE as a benchmark for industry excellence.

•  ISO 14001---Environmental Management Systems (EMS).
•  ISO 45001:2018---Occupational Health and Safety (OH&S) Management System.
•  ISO 17025---General Requirements for the Competence of Testing and Calibration Laboratories.
•  ILAC-MRA---International Laboratory Accreditation Cooperation - Mutual Recognition Arrangement, it is a global network of laboratory accreditation bodies.
•  CNAS---China National Accreditation Service for Conformity Assessment, it is an organization that is responsible for the accreditation of conformity assessment bodies in China.
•  cGMP---Current Good Manufacturing Practice (cGMP) regulations enforced by the U.S. Food and Drug Administration (FDA) to ensure the identity, strength, quality, and purity of drug products.
Customer Quality Service

The MCE Quality Assurance team ensures high standards throughout the customer consultation and communication process, offering:

•  Pre-sale quality consultation
•  Certificate of Analysis (COA)
•  Safety Data Sheet (SDS)
•  Product usage guidelines
•  Product data sheet
•  Chemical analysis report
•  BSE/TSE, origin, and animal source declaration
•  EU third-party QP GMP audits, client audits, official audits（such as state and provincial NMPA)
Quality Achievements

Multiple small molecule products have been registered with the U.S. FDA. As of May 2024, small molecule products related to ADCs have DMFs registered with the U.S. FDA, including:

•  MMAE CAS#474645-27-7 (DMF code: MF036741)
•  Vc-MMAE CAS#646502-53-6 (DMF code: MF#036740)
•  Exatecan mesylate CAS#169869-90-3 (DMF code: MF036708)
•  Trabectedin CAS#114899-77-3 (DMF code: MF036724)
Quality Service Philosophy — EHS Management: Upholding social responsibility with a commitment to environmental protection, health, and safety.
  • Enhanced technical assessment
  • Cleaner and safer production processes
  • Effective waste management
  • Rigorous process monitoring