QUALITY AND AUDITS

The quality unit consists of QC and QA and is independent of the production. The quality unit reports to the general manager.

The quality system is established in accordance with the GMP requirements of Chinese NMPA, US FDA 21 CFR parts 210&211 and EU GMP.

2Y-Biopharma Inspection and Audits (GMP DP manufacturing)：

Passed 6 GMP inspections by NMPA in recent 5 years.

Passed ＞100 customer GMP audits, including Chinese, US and EU customers.

Passed 3 EU QP remote GMP audit for clinical sample manufacturing.

US FDA SUBMISSION

US market: Contract Manufacturing and Commercialization Collaboration Project

2Y-Biopharma is partenering with a US company as their new manufacturing site of an FDA approved durg product. The PAS was submitted in 2025 and an FDA on-site inspection is expected in 2026.  We are committed and ready to support long-term stategic collaboration globally.