Home» Service» System Guarantee» GMP»
  • Quality Assurance System (GMP)
  • GMP Workshop and Facilities
Quality Assurance System

Quality management is the lifeline of Yaohaibio. We provide comprehensive quality management service following the quality policy of "quality-oriented, comprehensive and compliant, simple and efficient, solidary and cooperative" to achieve customers' satisfaction. We are engaged in providing samples conforming to the requirements of FDA, EMA, and NMPA for IND and clinical stages, as well as quality management service conforming to NMPA for commercialization production.

Quality System Development Principle

The quality system should cover the full life cycle of pharmaceuticals from development to commercial production.

The quality system should follow the current domestic and foreign laws and regulations, and comply with the legal and regulatory requirements of CMC (Chemical, Manufacturing and Control) activities.

The quality system should be flexible considering the characteristics of the CDMO business to satisfy high expectations for contract pharmaceutical manufacturing.

Document Assurance System

Yaohaibio has established a comprehensive document assurance system in accordance with GMP and closely integrated with company business model to cover all GMP activities of the company.

POL: Policy

SOP: Standard Operating Procedure

STP: Process Procedure, Specification, Standard Testing Procedure

Form: Records and numbers follow SOP and STP, independent approval

Comprehensive document system established to cover the following 10 systems
  • Quality management
  • Organization and personnel
  • Workshop and facilities
  • Equipment management
  • Materials and products
  • Qualification and validation
  • Document management
  • Production management
  • Quality assurance
  • Laboratory management
Regulatory Support

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.

GMP Workshop and Equipment

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.

Copyright © Yaohaibio - All Rights Reserved Web design

Live Chat
Get a Quote