4. Traditional Chinese Medicine (TCM) GMP Pilot Plant

Brief Introduction

This is Taiwan’s first institution-operated GMP pilot plant that meets international ICH standards and has passed the Ministry of Health and Welfare’s GMP facility evaluation (both software and hardware). It serves as an open-access R&D and pilot production platform for natural products, providing systematic and rapid-scale manufacturing and testing services. The facility supports new drug and health product development, establishing a scientific and standardized platform that accelerates clinical translation and commercialization.

Scope of Services

1. Process development, scale-up, and optimization studies

2. GMP manufacturing of preclinical and clinical trial materials

3. Identification and preparation of pharmaceutical/health-related compounds and reference standards

4. Analytical method development and validation

5. Product stability studies

6. CMC (Chemistry, Manufacturing, and Controls) documentation support

7. Health food development and certification guidance

8. GMP system implementation consulting

Info

• 呂亦晃

• +886-3-57343905

• loiseaubleu@itri.org.tw