Thousand Oaks Biopharmaceuticals strictly complies with NMPA, FDA, EMA and PIC/S requirements and integrates ICH Q-series guidance to operate a lifecycle quality management system covering R&D, tech transfer, clinical-supply preparation, commercial manufacturing and post-approval changes.
The company obtained its Drug Manufacturing License in January 2019 and has passed four combined registration and GMP Pre-Approval Inspections (PAIs). Multiple audits by NMPA, EU QP and international partners provide a regulatory-compliant foundation for China, US and EU submissions.
- Passed four consecutive combined registration and GMP pre-approval inspections (PAIs) and underwent 100+ customer and third-party audits in the past three years.
- A full-life-cycle QMS covering production systems, facilities & equipment, laboratory controls, materials, and packaging & labeling.
- Robust GMP training program with defined framework and objectives, traceable records, and mandatory onboarding, pre-release and ongoing on-the-job training.
- Digitized document, records and training management with risk-based backups to ensure data integrity, authenticity, traceability and auditability.
- Clear deviation, change and CAPA governance and processes aligned to product processes and technologies to assure quality requirements.
- Effective self-inspection, quality performance metrics and management review mechanisms to maintain QMS effectiveness and drive continual improvement.
Thousand Oaks Biopharmaceuticals maintains a four-tier QMS documentation framework and a bilingual (Chinese/English) system.
To protect IP, project-specific documentation is implemented. Electronic document, records and training management systems are used to further reinforce compliance.
