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We have embedded our “commitment to life” into the Yuanda Shuyang’s DNA
In the process of becoming an “international high-quality service provider covering the full product chain of blood products”
we are committed 100% to product quality, representing our“solemn commitment to life”
From the source of plasma to the production processes control,
from product end use to customer service,
we are benchmarked to international standards in every critical process,
constantly pursuing perfection
Source
We strengthen risk control measures at the headstream , including the operation of plasma collection stations, the full plasma collection process, and the screening of plasma donors, in order to eliminate any infection sources.
  • The construction and management of all plasma collection stations comply with the relevant regulations and requirements issued by the National Health Commission of the PRC, The relevant “Plasma Collection License” are obtained.
  • The management and screening of plasma donors are strictly adhered to the “Notice on Plasma Donors” issued by the National Health Commission
  • We have established an information management system for plasma collection stations, which enables traceability of all plasma donors and plasma information throughout the process
  • We have fully-equipped with automated plasma collection and testing devices to ensure the safety of the collection process and the accuracy and stability of the test results
  • We have established an comprehensive quality management system, covering the entire plasma collection process, which lays solid foundation for compliance.
Love
We pay great attention to the health of plasma donors and spare no effort in meeting the medication needs of patients.
  • Continuous health follow-ups are conducted for all plasma donors and monitor their physical well-being
  • We have established a warm-hearted mutual aid fund to provide additional support to plasma donors and their families
  • A patient care platform has been set up to help patients access to professional nursing information and address issues related to medication access
Control
We have established a robust testing line , to defense and eliminate the risk of viral transmission
  • Frist round Virus testing - ELISA
    01

    plasma collection

  • Second round Virus testing - ELISA
    02

    plasma retesting

  • Third round Virus testing - NAT
    03

    plasma retesting

  • 60days quarantine period (ELISA+NAT)
    04

    qualified plasma

  • Fourth round Virus testing (ELISA+NAT)
    05

    qualified pooled plasma for production

  • Virus removal/inactivation process
    06

    production

  • Fifth  round Virus testing - ELISA
    07

    final product

  • Launched to market only after batch release approval
    08

    qualified

Intelligence
As a model production base, the factory comprehensively equipped with Raw Plasma Management System, Warehouse Management System, LIMS, QMS, EMS/BMS, and other systems. By over 3600 self-control points, we control 500+ sets equipment in workshop and hundreds sets of quality testing devices, achieving highly automated production from plasma to finished products, and ensuring complexity in an orderly manner through stringent quality control.
Quality
  • The entire drug production process is supported by a professional validation team equipped with seven sets of environmental monitoring devices, ensuring real-time monitoring and early warning through the EMS system.
  • A comprehensive quality management system is in place to ensure that the six elements including people, machines, materials, methods, environment, and measurement are regulated and compliant throughout the drug production life-cycle.
  • Key production processes are monitored individually by quality assurance personnel, with staged release at critical production checkpoints to ensure prompt correction if any deviations occurred.
  • All categories tests required for blood products are covered, including microbiological tests, biological activity tests, physicochemical tests, and animal experiments.
  • After each batch of production is completed, strict internal control standards must be conformed.   Samples are tested by the China National Institute for Food and Drug Control or the Sichuan Provincial Institute for Drug Control. Before obtaining the Bioproduct Batch Release Certificate, the products are not allowed to be marketed.
Delivery
In terms of warehousing and logistics, we constantly innovate to achieve a high-storage, high-efficiency, high-standard, high-quality, and high-precision automated storage system for raw plasma and finished products. The entire cold chain transportation process is automatically temperature-controlled, with monitoring throughout and complete traceability of all transportation records.
  • Accurate temperature control
  • Maximum space utilization
  • WMS (Warehouse Management System)
  • Automated management system
  • Precise inbound and outbound control
  • Continuous monitoring of cold chain transportation