GC Biotech has always adhered to the principle of "quality first, quality first and excellence", and strictly followed GLP and GMP standards. Establish, implement and maintain a quality system that meets the requirements of GMP laws and regulations at home and abroad and the needs of customers, various analysis and testing methods from product development to cGMP clinical production, establish and verify the required analysis methods according to customer projects, and provide sample testing, analysis reports and analysis documents required for ind application. Provide products with quality attributes that meet customer needs, and adopt the strategy of continuous improvement to continuously improve the quality system of GC Biotech.
01.Quality management services:
Resource Management (personnel management, material management, plant facilities and equipment management)
product quality
Quality control management
Validation management
Process performance, product quality and pharmaceutical quality system monitoring and
Continuous improvement
02.Method development and Optimization:
Strain screening and medium optimization & Pilot plant process development
Validation of analytical method:
Characterization test & Release test (provide data support for ind declaration)
Sample test:
Reference calibration, product quality / process comparability study
Product release and stability study