Quality

The Quality Unit consists of independent Quality Control (QC) and Quality Assurance (QA) teams operating separately from Production. The Quality Unit reports directly to executive management, ensuring independent oversight of quality systems and regulatory compliance.

Our Quality Management System is established in accordance with GMP requirements, including Chinese NMPA, U.S. FDA 21 CFR Parts 210 and 211, and EU GMP guidelines.

Recent GMP Inspections & Audits

• Successfully passed 7 NMPA GMP inspections within the past five years.
• Successfully completed 100+ customer GMP audits, including audits from Chinese, U.S., and European clients.
• Successfully completed 3 EU Qualified Person (QP) remote GMP audits for clinical sample manufacturing.

US FDA Submission

U.S. Market: Commercial Manufacturing Partnership:

2Y-Biopharma is partnering with a U.S. pharmaceutical company as the manufacturing site for an FDA-approved drug product.

The PAS was submitted in 2025 and an FDA on-site inspection is completed successfully in June, 2026.

We are committed to supporting long-term strategic partnerships with pharmaceutical and biotechnology companies worldwide.