AUSTAR Provided Quality System Improvement Services in Phases for a State-Owned Traditional Chinese Medicine Manufacturer

Introduction:

Traditional Chinese medicine, as the treasure and important resource of the Chinese nation, has unique advantages in prevention, healthcare, disease treatment, and rehabilitation. In recent years, with the establishment and improvement of national policies, industry standards, mechanism systems, and service systems, and the continuous increase in domestic and international market recognition of traditional Chinese medicine, more and more enterprises are competing for innovative traditional Chinese medicine.

Customer Background:

The customer not only greatly diversified the product lines through a series of strategic measures, but also took advantage of the national policy to encourage the concentration of the pharmaceutical industry, and built a full industry chain by integrating pharmaceutical procurement and planting, pharmaceutical research and development and production, pharmaceutical sales and related health services, to consolidate its position as a leader in the field of traditional Chinese medicine. In order to maintain the customer's quality brand and achieve its long-term strategic goals, the customer is urgent to improve the quality management system, and enhance GMP management and implementation level, so as to meet the needs of rapid development.

Scope of Services:

As specified in the service contract, AUSTAR has provided the following quality system services in phases to the customer and its subsidiaries in successive years:

• In alignment with international regulations and technical standards: PIC/S, ICH, with reference to EMA, FDA and WHO GMP standards.

• In alignment with the quality management models of world-class enterprises: inviting a number of MNC quality experts for training.

• Quality system assessment.

• Establishment and improvement of key quality system documents.

• Quality risk management training.

• Special subject training in qualified person conference.

AUSTAR Contributions and Customer Benefits:

Based on years of knowledge accumulation and rich experience, AUSTAR has successfully delivered quality system improvement services, and brought the following benefits to the customer:

• Perform gap analysis and training based on PIC/S and ICH requirements, enhance the knowledge and skills of the customer team members with respect to GMP compliance, and assist in the successful implementation of all documents related to quality management system and validation system.

• Assist the customer in establishing a sound quality management system based on the knowledge and experience of MNC experts, and building an excellent validation and quality management team, integrate knowledge management into the customer’s enterprise culture, and establish a quality brand for the group company.

• Assist the customer in establishing a quality audit system, and building a professional quality audit team, continuously improve the customer’s GMP management level, and reduce the risks caused by unannounced inspections and quality issues.