● SMP
● SOP
● STP
● SOR
Ensuring the quality and compliance of oligonucleotide manufacturing processes is crucial to clinical development goals of our partners
According to the laws, regulations and guidelines related to drug production issued by domestic and foreign authorities such as ICH、FDA、EMA、NMPA、PIC/S., To ensure that the quality of delivered oligonucleotides is consistently stable and meets the requirements of domestic and foreign laws and regulations, we have established a comprehensive quality management system: document management, equipment management, plant facilities, organization and personnel, materials and products, manufacturing management, quality assurance, quality inspection, confirmation and verification, self-inspection and many other aspects.
