AUSTAR Provided Quality System Enhancement Service to a large integrated modern TCM group

Modernizing a 5,000-Year Legacy: Traditional Chinese Medicine (TCM), a cornerstone of Chinese cultural heritage, now integrates advanced technologies like precision extraction and GMP-compliant production to standardize active constituents. This evolution elevates therapeutic efficacy, safety, and quality control, aligning with global regulatory standards. Today, modern TCM thrives domestically and gains international recognition as a science-backed, holistic healthcare solution.

Project Background:
The client is a large comprehensive enterprise group primarily engaged in the modern Traditional Chinese Medicine (TCM) industry. Its main business covers the entire industrial chain, including the cultivation of Chinese medicinal herbs, TCM preparations, TCM formula granules, TCM decoction pieces, healthcare products, biopharmaceuticals, chain pharmacies, TCM clinics, and internet healthcare. The client is committed to the modernization and internationalization of TCM research and development, establishing extensive collaborations with numerous domestic and international research institutions, and actively promoting the internationalization of the enterprise and the TCM industry.

AUSTAR Solutions:

• Comprehensive gap analysis of the pharmaceutical quality system.

• Supplementation of quality system documentation.

• Optimization of the quality management system and development of targeted enhancement plans.

• Specialized training.

AUSTAR Value and Client Benefits:

• Effectively identified gaps between the client's current quality management system and PIC/S GMP requirements.

• Built a robust quality system, focusing on TCM injections, and comprehensively enhanced the quality system across six major systems and ten sectors of the headquarters and entire plant.

• Through project execution, effectively improved the client team's regulatory compliance capabilities, established a robust quality system, and created a learning organization capable of continuous improvement.

• Enabled the client to replicate AUSTAR's service model and independently complete quality system enhancements for other facilities.