Email: cspc@cspc.cn
Quality Assurance
As a pharmaceutical company with product innovation, R & D and manufacturing as the core business, CSPC regards quality as its lifeline and has always taken product quality as the first core competitiveness.
Quality Guideline
Ingenuous manufacturing with craftmanshiip and high quality to create excellent CSPC
Quality Concept
Manufacturing products with love and transmitting
Quality Culture
Producing high-quality medicines with heart
Our Product Quality Commitments
Strictly following and implementing the requirements of relevant laws and regulations, and ensuring the integrity in our business operations, abiding by laws with integrity and restraining from deceptive or fraudulent practices during the course of production, processing, sales, brand promotion and after-sales service.
01
Establishing product quality standards according to the national pharmacopoeia of relevant products to ensure that the products comply with the quality requirements and with laws and regulations.
02
Constructing a sound quality management system which covers all product life cycles and continuously enhancing quality management through internal audit and management review.
03
Ensuring that the measurement tools, instruments and equipment used for product inspection are calibrated by qualified calibration institutions, so that all quality inspection activities are stringent and effective, and relevant quality management records are traceable
04
Implementing product traceability management with the help of ERP, SAP, MES, WMS and other management systems and product traceability system
05
Focusing on customers’ needs, improving after-sales service management system, striving for excellent aftersales service, and taking customers’ satisfaction as the code of conduct of the Group.
06
Product Quality System
The Group has always strictly abided by the national laws and regulations on product quality and safety, and has established a comprehensive quality management and whole process traceability system with a focus on prevention, which ensures quality management of drugs during the whole life cycle.
A four-level quality assurance system is implemented in the Group, and a professional quality management team in the Group is responsible for quality control and quality assurance management of each subsidiary.
Four-level Quality Assurance System
Group-level/
QualityManagement Department
Formulating quality strategy
Establishing
Company-level/
Quality Management Department
Establishing quality management system
Ensuring effective operation of quality system
Class-level/
Quality Officer
Strictly executing SOP
Supervising
Departmentlevel/
Quality Team
Implementing quality system
Supervising
Product Quality Certification Management
In recent years, CSPC has been focusing on improving product quality standards, implemented internationalisation strategy, and carried out quality management in all processes in strict accordance with the provisions of various certifications. During the reporting period, CSPC has undergone 48 times of all various inspections from domestic drug regulatory authorities and passed them successfully. The major domestic and international certifications passed up to 2021 are as below
13 CEP certificates
25 DMF filed
25 products passed the inspection by US FDA
Product Production Quality Control
The Group adopted SAP system as the main system supplemented by professional management system. The Group promotes intelligent manufacturing through construction of information system. A whole chain management system has been established, from material incoming, production control, delivery of finished products to distribution, which can achieve effective management and continuous improvement in the product life cycle by combining with the existing information system.
"Modern Intelligent Equipment"
"Intelligent Manufacturing for Internationally Recognised Products"
The production workshops are designed and built in accordance with the standards of "intelligent manufacturing" and "internationalisation". which are of the international leading standards.
Quality Risk Management
The Group attaches great importance to the medication safety of patients and is committed to managing quality and safety risks well. Meanwhile, the Group has constructed a sound pharmacovigilance system and successfully implemented the management system and various processes of the drug safety committee in the preparation companies.
The effective execution of the pharmacovigilance management system, management system of drug safety committee and emergency response system for major drug safety events in the Group ensures that emergency measures can be rapidly taken in case of mass and major adverse reaction events, and timely reported to the National Medical Products Administration, local provincial and municipal pharmacovigilance centres and other relevant departments. At the same time, each preparation company of the Group submits the annual pharmacovigilance report every year and update the regular drug safety report on time.
