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