Sustainability Development
While focusing on new drug development, TWi Biotechnology Inc. also considers the impact of its business activities on the environment and society. We aim to work together with the society toward sustainable development and shared prosperity. Therefore, we have established two sustainability guidelines—Product Quality Assurance and Environmental Protection—believing that implementing these principles will make contribution to society.
Product Quality Assurance
Our company is primarily engaged in the research and development of pharmaceutical products for human use. We place great emphasis on product quality and safety, requiring all suppliers and contract manufacturers to comply with the highest quality and safety standards.
We require all our suppliers and contract manufacturers to establish comprehensive and strict environmental management systems, with production quality meeting cGMP standards and passing U.S. FDA inspections.
| Pharmaceutical Manufacturing Facility | Inspection Date | Inspection Scope |
|---|---|---|
| TWi Pharmaceuticals Inc. – Zhongli Plant (Building 1) |
November 2006 | Taiwan Department of Health cGMP Certification |
| November 2006 | U.S. FDA Pre-Approval Inspection | |
| October 2008 | Taiwan Department of Health cGMP Certification | |
| April 2012 | PIC/S GMP | |
| May 2014 | U.S. FDA Pre-Approval with GMP Inspection | |
| May 2014 | PIC/S cGMP & GDP Inspection by Taiwan FDA | |
| July 2018 | Passed U.S. FDA cGMP Inspection | |
| TWi Pharmaceuticals Inc. – Zhongli Plant (Building 2) |
May 2014 | U.S. FDA Pre-Approval with GMP Inspection |
| September 2014 | PIC/S GMP | |
| August 2015 | Taiwan FDA Inspection for New Dosage Form | |
| December 2016 | U.S. FDA Pre-Approval Inspection (PAI) | |
| May 2017 | Passed Taiwan FDA PIC/S cGMP Assessment | |
| May 2018 | Passed Taiwan FDA Inspection for New Dosage Form & GDP Compliance | |
| July 2018 | Passed U.S. FDA cGMP Inspection |
Environmental Protection
We outsource drug formulation and production, avoiding the use of resources that heavily burden the environment. We strive to reduce carbon emissions through waste segregation (e.g., recycling containers, regular shredding and recycling of paper), waste reduction (e.g., reusing paper, eliminating disposable cups, using email for communication), temperature control, and environmental greening. Our goal is to minimize environmental impact through low-pollution business activities.