Recently, Yuanda Shuyang human immunoglobulin (pre-filled syringe packaging) was officially approved by National Medical Products Administration, and the drug approval number was: GYZZ S20247006.

Pre-filled syringe makes medication safer, more accurate and more convenient.

Starting from the needs of patients, we innovatively use pre-filled syringe packaging to improve the accuracy of administration, reduce pollution and provide better experience for patients.

Safe  Pre-filling, no need for extraction, reducing the risk of pollution.

Accurate  There is no need for secondary transfer for medication dispensing before injection, which improves the accuracy of dosage.

Convenient Direct injection administration improves the operation efficiency of medical staff and improves the medication experience of patients.

Strengthen the quality management of drugs in the whole lifecycle.

Yuanda Shuyang has always adhered to the quality management concept of "one dose of medicine, two lives". We implement comprehensive quality management mode to continuously improve product quality and provide patients with safe, reliable, high-quality and trustworthy blood products.

Man

The production of blood products is a highly professional work bearing great responsibilities, which is related to human life and health. Yuanda Shuyang has a group of professional and stable high quality talents. We always put the cultivation of employees' high sense of responsibility and awe at the top of corporate culture. At the same time, we conduct professional and systematic trainings on laws, regulations, microbial knowledge and job operation skills every year to continuously improve the professional level and quality awareness of employees.

Machine

The main production equipment is international first-class brands and fixed position equipment with independent knowledge patents; PCS centralized control is adopted to realize the automation of monitoring and process control in the full process section, reducing manual operation errors and improving production efficiency.

Material

Establish comprehensive supplier screening standards and rigorously enforce audit management to control material quality from the source.

Introduce automatic and information-based material management system, and achieve more efficient management and quality traceability.

Method

Yuanda Shuyang has established a quality management system that meets both China GMP and EU GMP.

The quality assurance system follows PIC/S requirements and CCS pollution control strategy, and is regularly evaluated and verified to standardize production methods and technological processes to ensure the stability and consistency of products.

The product registration standard is stricter than that of Chinese Pharmacopoeia.

Yuanda Shuyang is one of the first batch of blood product manufacturers in China that have passed the ISO9001/ISO14001/IS045001 quality, environment and occupational health and safety management system certifications. These certifications not only prove the standardization and normalization of Yuanda Shuyang in the production management process, but also further improve the management level in key areas.

Environment

According to the advanced concept of strict separation of people flow and material flow before and after viral inactivation, the risk of cross contamination is reduced. Each production functional area has an independent HVAC system, and EMS control is adopted to ensure that the production environment is monitored in real time and is always in the best state.

During the filling process, airborne particles, settling microbe, airborne microbes, etc. are monitored throughout the whole process, and microbial monitoring is carried out after the production to ensure that the production environment is sterile.

Yuanda Shuyang always adheres to the "patient-oriented" concept, and constantly makes innovations in medicine packaging form and administration mode, so as to improve the compliance and convenience of clinical administration. At the same time, Yuanda Shuyang adheres to the development path of "high quality standard, full product coverage and market internationalization", roots on full range of blood products such as albumin, immunoglobulin and coagulation factor, and expands into the fields such as gene recombination, etc., and strives to become "an international high quality service provider for full product chain of blood products".