Quality

The company in accordance with the requirements of the EU GMP and China GMP combined with the company's strategic decision-making to establish quality management system, the use of modern quality management tools and risk management methods to ensure its effective operation and continuous improvement, aimed at minimizing the pharmaceutical production process pollution, Pollution and confusion, errors and other risks, to ensure continuous and stable production to meet the intended use and registration requirements of drugs, the protection of the interests of patients

Quality Policy

"Quality first, continuous improvement, scientific management, and pursuit of perfection”
天麦生物

Quality Objective

To ensure the provision of high quality drugs for patients and to maximize the protection of the interests of patients.

Institutional Setting

1. The quality department is responsible for the company's daily quality management, and consists of the quality assurance (QA) department, and the quality control (QC) department, responsible for the implementation of various quality management functions.

2. Quality Director, as the person in charge of the company's quality management and the Qualified Person, assists the General Manager with quality management and is responsible for establishing and improving the company's quality management system, carrying out the relevant laws and regulations, monitoring the quality management system and ensuring its effective operation.

3. General Manager is the person in charge of the enterprise, and the principal responsible person for drug quality, and fully responsible for daily management of the enterprise.

Quality Management System Evaluation

The company evaluates the effectiveness and compliance of the quality system at least once a year through means including but not limited to self-inspection, regular product quality review and management review, and proposes evaluation suggestions and the implementation of quality improvement measures involving specific departments.

Customer Orientation

The company provides the necessary resources to meet customer needs and expectations, and evaluates the effective operation of the quality management system through the measurement of customer satisfaction to achieve continuous improvement of the system.