The API factory includes preparation area, extraction area, concentration area, chromatography area and clean room for packaging. The content of oxygen and solvent in production area are monitored throughout the process. An automated production process has been adopted to improve production efficiency. Production area for finished pharmaceutical product includes weighing area, emulsification area, filling area and automatic packaging area.
The integrated quality system of the Nanchou plant of Oneness Biotech is established based on the part I and part II of PIC/S GMP with implementation of comprehensive quality control. From incoming materials, sampling, processing, packaging, labelling, storage, to logistics distribution, all are included in quality control system to ensure the safety, effectiveness and consistency of the pharmaceutical product.
Nanchou plant has been inspected by TFDA and obtained PIC/s GMP in April 2021. Nanchou plant will apply for PIC/s GMP inspection by the European, American and Chinese regulatory authorities along with our market plan for product launch.