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Your Assurance of High-Quality Cell Culture Media

Eminence upholds a sacred pledge to furnish the life industry with superior-quality cell culture media and corresponding supplements. Our adherence to the highest industry standards reflects our unwavering dedication to this commitment.

Our Quality Management System is constructed on a strong foundation of regulatory requirements and guidelines:
  • FDA 21 Code of Federal Regulations Part 210, Part 211, Part 11 and QSR820
  • EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use
  • Good Manufacturing Practice for Drugs (2010 Revision)
  • ICH Q7 Good manufacturing practice for active pharmaceutical ingredients
  • ISO13485:2016
  • ISO9001:2015
 
Our system, certified under the ISO 9001, casts its meticulous gaze over every step of our operations - from the judicious selection of raw materials to the final approval of finished products.
 
To ensure we deliver the apex of quality and consistent product performance, our production processes and testing methods have been fully validated. Such stringent measures pave the way to guaranteeing lot-to-lot consistency and the quality of our products.

Eminence continues to champion its values of 'Expertise, Evolution, and Excellence', standing tall as a beacon of quality and commitment in the world of cell culture media products and services. Your trust fuels our relentless drive to maintain high standards and to continually push the boundaries of quality and consistency.
 
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   Quality System
 
  • Quality Policy & Objective
  • Quality Management Review
  • Quality Risk Management
  • Deviation / Change Control / CAPA
  • Complaint
  • Self-Inspection
  • GMP Training
  • Documentation Management
  • Vendor Qualification
  • Raw Material & Product Release
  • Recall
  • Data Integrity
  • Annual Product Quality Review
  • Quality Agreement
  • Computerized System Validation
 
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   Production Control
 
  • Master Production & Control Document
  • Batch Production Record
  • Facility & Equipment Cleaning
  • Facility & Equipment Maintenance
  • In-process Control
  • Holding Time Study
  • Clearance & Visual Inspection
  • Cleaning Validation
  • Process Validation
  • Process - Containment Control
  • Personnel Hygiene
  • Sanitation
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   Laboratory Control
 
  • Samples Management
  • Stability Study
  • Reference & Working Standard Management
  • Solution & Reagent Management
  • Specification Management
  • Testing Data Control
  • Test Method Management
  • Logbook Management
  • Environment Control Program
  • Qualification of Analytical Equipment
Supported Compliance

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