Quality Management
Overview
Through rigorous quality governance and cross-functional collaboration, we ensure that every product is delivered with safety, consistency, and reliability, supporting the sustainable development of the global pharmaceutical supply chain.
Quality Assurance
Our integrated Quality organization — encompassing QA, QC, and Regulatory Affairs — ensures that every process complies with 21 CFR Parts 210/211 and ICH Q7.
Through a robust quality system and risk-based management, we maintain product integrity, consistency, and full traceability from raw materials to commercial APIs.
Our APIs have successfully passed inspections by the U.S. FDA, European authorities, and Japan PMDA, reflecting our commitment to transparency and global standards.
Through rigorous quality governance and cross-functional collaboration, we deliver APIs with safety, stability, and reliability, supporting the sustainable growth of the global pharmaceutical supply chain.
Core Quality Functions
- Releasing or rejecting raw materials, intermediates, packaging materials, labeling components, and APIs
- Reviewing batch production and analytical records prior to API release
- Investigating and resolving critical deviations and quality events
- Approving procedures and change controls that may impact API quality
- Conducting internal audits and ensuring timely completion of corrective actions
- Reviewing and approving validation protocols and reports
- Investigating and responding to quality-related customer complaints
- Maintaining stability programs to support retest/expiry dates and storage conditions
- Performing periodic product quality reviews (PQR/APQR)
- Preparing, submitting, and updating DMFs and related regulatory files
- Maintaining compliance with global GMP certifications and inspection requirements
GMP Inspection
Equipment for QC
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