We sporadicly invite well-known third-party GMP consulting companies at home and abroad to ensure continuous improvement. We also regularly invite experts with FDA background as consultants to solve problems arising along with the operation.

Located in the China Medical City in Taizhou, Jiangsu, Yaohaibio Taizhou production base covers more than 10,000 m² GMP production plants, designed followed the concept of Quality by Design (QbD). The production line conforms to the standards of NMPA, FDA and EU GMP, and can support registration application globally.

Currently, there are 5 microbial fermentation and purification production lines conforming to GMP requirements. Each production line in the production area is equipped with an independent clean air conditioning system not interfered with each other, 2 drug product production lines adopt the independent modular design to avoid cross-contamination, and a modern quality research service center with a quality inspection platform covering physiochemical, biochemical and microbiological testing.

The design, operation and management of workshop all comply with GMP. All production personnel have received comprehensive GMP training, QA and validation personnel ensure production management in the GMP plants following the requirements in document system, to ensure production process replicable and traceable. Effective implementation of GMP management system in the workshop, as well as the compliance and reliability of production process promote product registration and commercial production of innovative drug with efficiency and high-quality.