Nanchou Plant

 

Nanchou Plant 

Manufacturing
Oneness Biotech has set up the " Good Agricultural and Collection Practices " for control of botanical raw material and established a manufacturing plant under PIC/s GMP standard, covering an area of 19,494 square meters for active pharmaceutical ingredient (API) and the finished pharmaceutical in Nanchou, Pingtung. Under PIC/s GMP standard, the risk of human intervention and cross-contamination has been reduced while production efficiency and product quality can be greatly increased.

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; and adopts an automated production process to improve production efficiency. Production area for finished pharmaceutical 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, and logistics distribution, all are included in quality control system to ensure the safety, effectiveness and consistency of the pharmaceutical product.

Nanchou plant has been applied for TFDA PIC/s GMP factory inspection in May 2020, and will accept PIC/s GMP inspection by the European, American and Chinese regulatory units in line with our market plan for product launch.