Quality and Compliance

Since its foundation, ScinoPharm has instated environment, health, and safety (EHS) as one of its core values and has implemented its principles through management policies to continuously improve its EHS standards. ScinoPharm strictly adheres to regulations on labor health protection and occupational safety and health. By meeting international quality standards and stringently enforcing EHS measures, we have built long-term strong partnerships with various multinational pharmaceutical companies. With professional vigilance, we remain committed to providing quality products and guaranteeing environmental protection as well as workers's afety.

 

Quality Compliance and Management

ScinoPharm Taiwan’s product control strategy ensures compliance with Current Good Manufacturing Practices (CGMP) requirements. Our staff must receive official CGMP training upon joining the company and attend recurrent training thereafter. Our production process fully complies with CGMP’s ICH Q7 (Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients) guidelines and abides by the enumerated procedures and specifications. Combining well-trained personnel and facilities that meet international standards, ScinoPharm can manufacture high-quality potent APIs.

 

Intellectual Property Compliance

ScinoPharm Taiwan’s strong R&D and technical capacities enable the development of exclusive manufacturing processes that do not conflict with existing patents. Furthermore, with strict adherence to industrial confidential information and intellectual property protection, coupled with rigorous quality assurance and quality control compliance, ScinoPharm has been chosen in a competitive environment by major pharmaceutical companies worldwide as a trusted partner.

 

Responsible Care/EHS/Waste/AEO Authorization

Our stringent enforcement of codes related to environmental protection, labor health protection, and occupational safety and health is aimed to alleviate our customer’s concerns for potential EHS liabilities. Meanwhile, our AEO status confers trading advantages such as cargo security and accelerates customs clearance.

 

Highlights

• US FDA Inspection(.pdf)
• Japan PMDA Inspection(.pdf)
• German Authority GMP Certificate(.pdf)
• Australia TGA Inspection(.pdf)
• Hungary NIP Inspection(.pdf)
• Korea FDA Inspection(.pdf)
• Mexico COFEPRIS Inspection(.pdf)
• Taiwan DOH GMP Certificate(.pdf)
• Responsible CARE Program (.pdf)
• Responsible Care Management System Verification (.pdf)
• Intellectual Property Safeguards (.pdf)
• AEO Certificate (.pdf)