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Intellective Bio.
Quality Assurance
Intellective University
Quality Assurance
  • Quality Policy
    Our services are guaranteed to be of high quality and reliability, with a commitment to continuous improvement to ensure customer satisfaction, and all activities comply with the requirements of the Quality Management System and current regulations.
  • Quality Objectives
    Develop scientific, safe, and compliant quality control strategies based on the principle that quality by design ensures that customer and stakeholder needs are met.
Intellective Bio has established a Quality Management System (QMS) based on the QbD concept in accordance with the requirements of NMPA, FDA, EMA, ICH, WHO and other regulations. The document management system is designed as a four-level to ensure that all GxP activities are compliant and effective through standardized and systematic written SOPs. Intellective Bio's compliance and science-based QMS enables more innovative biopharmaceutical companies to commercialize their products.
QA system is including the following
  • Document management
  • Quality risk management (QRM)
  • Deviation management
  • OOS
  • Change controls
  • CAPA
  • Complaint management
  • Product recall management
  • Supplier management
  • Self-inspection and external audit
  • Confirmation and validation
  • Annual Management Review
  • Quality agreement management
  • Continuous improvement
IQuality Management System
Quality Management System
Materials System
Lab System
Project and Knowledge Management
Quality Assurance System
Manufacturing System
Facility,Utility & Equipment
Organization and Personnel
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