Nanchou Plant ▍ PIC/S GMP Manufacturing site

PIC/S GMP Manufacturing site 

The manufacturing site is located in Nanchou Township, Pingtung County, following the sustainable, environmental friendly core value. The plant has passed ISO 14000 qualification in 2021. In addition, the Nanchou plant was built under the standard of international PIC/S GMP standard. The GMP certificates of drug substances and drug products were granted in 2020 and 2021, respectively.

Botanic Raw Material
In order to ensure appropriate and consistent quality of medicinal plant/herbal substances, Oneness established good agricultural and collection practice (GACP) for herbal starting materials. Post-harvest, the botanic raw materials are produced hygienically, in order to reduce microbiological load to a minimum, and are handled with care so that medicinal plants/herbal substances are not adversely affected during collection, cultivation, processing and storage.

Quality System

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 raw 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 was successfully passed TFDA inspection and qualified PIC/s GMP in April 2021. Nanchou plant will continue to apply for PIC/s GMP inspection by the European, American and Chinese regulatory authorities along with market plan for products launch.