Quality & Compliance

Quality and Compliance is one of our core competencies. All members of our organization are held responsible and accountable for the highest standards of quality and compliance, starting with the head of our company. Our manufacturing facility is designed to comply with ISO 9001/14000 standards, ICH cGMP requirements (in accordance with ICH Q7A guidance), and Chinese SFDA GMP requirements.

Quality Assurance

Our independent quality assurance group has the mandate and authority to oversee all quality activities of our organization. Quality Assurance routinely conducts facility audits to ensure full compliance with cGMPs. The QA group is also responsible for approval and release of all final product batches and documentation.

Compliance

Our time-tested and engineer-controlled compliance systems are ranked among the best in the industry. Our compliance systems are founded on FDA's system-based inspection and risk-based GMP approaches. Over the last 10 years, our cGMP systems have been successfully inspected by US-FDA and EMA.