Quality Services
Quality
We are dedicated to delivering high-quality products and services. Through a commitment to continuous improvement, we drive clients success and ensure full adherence to both our Quality Management System and applicable regulatory standards.
Senior Management Navigation
Quality
Senior management shall assume ultimate accountability for quality objectives, with the quality policy as the core guidance, coordinate resources, delegate authorities and responsibilities level by level, focus on client requirements, control risks associated with drug research and development and production throughout the entire life cycle, foster quality culture, and drive continuous improvement of the quality management system.
Quality Management
With "excellent quality and compliance first" as the core, we establish the quality management system covering the entire life cycle of pharmaceuticals, integrating global regulatory requirements such as NMPA, US FDA, EMA, and ICH guidelines, to ensure that every link from research and development to commercial production complies with international standards.
Organization and Personnel
Materials System
Lab System
Project and Knowledge Management
Quality Assurance System
Manufacturing System
Facility,Utility & Equipment
Quality Management System
D&T
Document & Training Management System
WMS
Warehouse Management System
LIMS
Lab Information Management System
Quality System Overview (Documentation System)
Quality Management Overview
Quality Objectives
Quality Risk Management
Change Control
Data Integrity Management
Deviation Management
Out-of-Specification/Out-of-Trend
Corrective Action and Preventive Action
Regulatory Monitoring
Audit and Self-Inspection
GMP Training Management
Material and Supplier Management
Complaint and Recall Management
Compliance
4
Passed the on-site inspections by NMPA
6
Passed the on-site audits by EU QP
19
Passed the on-site audits by Provincial Drug Administration
242
Passed the on-site audits by Clients and Third Party
Related Content
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First Commercial Production Project Receives NMPA Approval
Company News
2025/10/17 -
Intellective Bio's Commercial Production Project Approved
Company News2025/01/26 -
Once Again! GMP Compliance Inspection Passed
Company News2024/06/26 -
Intellective Bio's Suzhou Industrial Park GMP Manufacturing Site Passes EU QP Certification
Company News2022/12/31
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