Sihuan Pharm

Sihuan Pharmaceutical has established a Production and Quality Center at Group headquarters to oversee quality management across pharmaceutical manufacturing. From systems and mechanisms to process controls, it ensures that qualified, trusted products reach the market — giving peace of mind to physicians and patients alike.

Principles and Policies

Quality principle: Sihuan Pharmaceutical is committed to providing patients with safe and effective products that meet regulatory and customer requirements, and continuously improves quality management through a scientific, effective, risk-based corrective and preventive action system.

Safety principle: The company complies with national and local occupational health and safety laws, regulations, and related requirements. Protecting employee safety and health in production and operations is a strategic goal, and all employees are encouraged to drive continuous improvement in occupational health and safety.

Management Structure

The Group has established a Production and Quality Center to supervise and guide GMP compliance and the operation of safety and quality management systems at each manufacturing enterprise, ensuring compliant operations, preventing safety incidents, and producing safe, effective, and consistent medicines that meet registered standards and intended use.

The Center includes Quality Management and Safety & Environmental Protection departments that oversee quality and EHS work across the Group’s manufacturing enterprises.

Assurance Measures

The quality management team continuously improves the enterprise quality management system through self-inspections, Production and Quality Center audits, quality reviews, quality team activities, and external training.

Each manufacturing enterprise operates through clear systems, defined responsibilities, implemented management, strengthened supervision, and full employee participation. The Group EHS department drives continuous improvement through regular safety audits to steadily refine the safety management system.

GMP Certification and U.S. FDA On-Site Inspections

Each of the Group’s manufacturing enterprises has extensive experience preparing for certification inspections and maintains inspection-readiness procedures that guide employees to support regulatory or third-party on-site inspections in a scientific and efficient manner.

Based on the different regulatory risks of each manufacturing enterprise, the Group develops targeted annual quality audit plans and completes audits of subordinate manufacturers strictly according to those plans.