Quality Standards and Management

ScinoPharm Taiwan is firmly committed to placing patient safety at the core of everything we do. All products are manufactured in full compliance with international cGMP standards, including PIC/S GMP, ICH Q10, FDA, EMA, and TFDA requirements. Through the implementation of Quality Risk Management (QRM) and Quality by Design (QbD), we embed risk-based thinking and quality principles from early development through commercial manufacturing. Our digital Quality Management System (eQMS) ensures transparency and full traceability of documentation, while advanced data analytics enhance deviation investigations, process monitoring, and continuous improvement. ScinoPharm undergoes regular audits by global health authorities and trusted partners, consistently meeting the highest standards of regulatory compliance. We also invest heavily in training and professional certification to ensure our teams remain up to date with evolving scientific knowledge and international regulations. By leveraging Quality Metrics, we drive continuous optimization and innovation, demonstrating our commitment to compliance, excellence, and delivering medicines that patients can trust.

Responsible Care & EHS

ScinoPharm adheres to the CGMP and to the Responsible Care® Initiative of the Taiwan Responsible Care Association (TRCA). The Responsible Care® is a voluntary commitment made by the international chemical industry to continuously improve performances on the environment, health, and safety. The Responsible Care® is implemented by having executives sign a Statement of Commitment, implementing the Codes of Management Practices, conducting self-evaluations, implementing management system verification (MSV), requiring that companies submit SHE Performance Indicators Reports, and having chemical companies share their experiences with implementing Responsible Care® with each other to help companies establish a comprehensive set of safety, health, and environmental systems.

The Pharmaceutical Supply Chain Initiative (PSCI), a group of internationally renowned pharmaceutical and healthcare companies, has established the PSCI Principles for Responsible Supply Chain Management, setting the social and ethical standards for supply chain management, which can be used to address five areas of responsible business practice: ethics, labor, health and safety, environment, and management systems. The Company has passed the PSCI audits by our pharmaceutical partners, which is a testament to our adoption of international business practices and standards in our occupational safety, health, and environmental management systems.

To reduce unacceptable risks from process hazards during R&D and mass production, ScinoPharm adopts a four-stage process hazard analysis (PHA): process hazard analysis in the lab (Lab PHA), inherent hazard analysis (PHA1), reactivity hazard analysis (PHA2), and operational hazard analysis (PHA3). In addition, safety testing and analysis is performed using various laboratory equipment (e.g., differential scanning calorimeters, reaction calorimeters, and adiabatic calorimeters (PHI-TEC II)) to assess safety issues caused by thermal hazards of chemical reactions. Drug toxicity prediction software (Derek Nexus and Sarah Nexus for Windows) is used to predict the hazardous effects of chemicals for which there are insufficient toxicological data.

For hazards that may arise from process modifications or engineering changes, change management procedures are adopted to assess and mitigate the potential risks of change. In operational safety control, we have procedures in place for hazardous operations, locking and tagging, and limited space management. Procedures for chemical use, safe inventory, and standard packaging are strictly controlled. A complete range of personal protective equipment has been prepared for operators to ensure their safety when using and storing chemicals.

Air pollution Disposal

In accordance with the EPA’s announcements with respect to general air pollutant emissions, the Company is categorized as the fourth group of emission sources involved in pharmaceutical and general manufacturing procedures for which the issuance of installation/modification permits and operating permits shall be applied. Our boilers and furnaces are fired using natural gas, which produces air pollutants containing nitrogen oxide and hydrocarbon. Air pollutants emitted from production processes are processed through two rows of condensers (which are filled with different types of refrigerant to supply the required cooling temperature) to remove volatile organic compounds, and then through a scrubber to remove acidic gases or alkaline pollutants. To manage fugitive emissions from storage facilities and equipment components, we outsource inspection services on a quarterly basis as required by law and also carry out inspection works from time to time to check equipment components for leaks and request for repairs when a leak is detected.

Waste Disposal

ScinoPharm is able to treat or clean all the waste generated within the plants, including biodegradable wastewater, waste solvents, solid waste, and air pollutants. Biodegradable wastewater is treated on-site until it meets the park’s required standards before it is transported to the park’s wastewater treatment plant for processing. Other liquid waste or solid wastes are transported to the park’s resource recycling center or incinerated by an outsourced waste disposal company.

AEO

Scinopharm Taiwan has been officially certified by Customs as an “Authorized Economic Operator,” the highest recognition for excellence in supply chain security management and trade compliance. The AEO (Authorized Economic Operator) certification program is designed to foster a secure and reliable international trade environment. Through rigorous assessment criteria, it ensures that certified enterprises meet global standards in cargo security, information security, and trade safety.We are committed to maintaining high operational standards and continuously enhancing our practices to provide safer and more efficient trade services for our customers.

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