Production Quality
Sihuan Pharmaceutical sets up a production quality center at the headquarters of the Group, and the center is responsible for the overall quality management during production. From logistics to system mechanism, it ensures that qualified and reliable products are provided to the market.
Concepts and Policies
Concept of Quality: Sihuan Pharmaceutical is committed to provide safe and effective products to patients, ensuring that the products provided meet the requirements of regulations and customers, and continuously improving its quality management level by establishing a scientific, effective and risk-based corrective and preventive measures system.
Concept of Safety: Sihuan Pharmaceutical abides by national and local laws, regulations regarding occupational health and safety and related rules. Sihuan takes "protection of the safety and health of employees in production and operation activities" as one of its strategic objectives which attaches importance to continuous improvement in occupational health and safety work, and encourages all employees to pursue such continuous improvement.
Organizational Structure
The Group has established a production quality center, which is responsible for supervising and guiding the compliance with GMP regulations and the operation of safety and quality management systems in pharmaceutical production of the production companies under the Group, ensuring their compliant operations and preventing safety accidents, and ensuring that they produce safe and effective drugs of consistent quality, meeting registration standard and fit for intended use.
The center has set up a quality management department and a safety and environmental protection department to supervise the quality, safety and environmental protection of the production companies under the Group.
Improvement Measures
Sihuan quality management team gradually improves the quality management system through its self-inspection and the production quality center's audit, quality review, quality group activity, and external training.
The company's safety management system will continuously and gradually improve by establishing systems, clarifying responsibilities, implementing management, strengthening supervision, and encouraging engagement by all employees on the part of each production company, and through regular safety audits on the part of the Group's EHS department.
GMP Certification, U.S. FDA's On-site Inspection
The production companies under the Group have extensive experience in preparations to meet the requirements of certification inspections, and have all established preparation management procedures for inspection to instruct their employees to scientifically and efficiently cooperate with drug administration departments or third parties on on-site inspections.
The Group formulates targeted annual quality audit plans based on the regulatory risks faced by each subordinate production company, and conducts audits on subordinate production companies in strict accordance with the quality audit plans.