R&D And Quality
Quality System
Quality Policy
To ensure the safety of life by quality
Quality Culture
Quality speech innovation and meritorious service Responsibility Lide
Quality Objectives
Ensure that drugs are safe and effective, compliant production, continuously improve quality and service, protect patient health, and achieve sustainable development.
GMP History
October 2023
October 2023
November 2024
November 2024
Standards and requirements
In accordance with the requirements and standards of the new version of GMP and EU GMP, Lihero has formulated relevant procedure documents and operation documents to control the whole process of materials, production, inspection and sales, confirm and verify the facilities, equipment and instruments of the plant, and verify the production process, cleaning process, inspection methods and products.
All activities are carried out in accordance with the prescribed procedures and in accordance with the verified status. For the occurrence of deviation, the "deviation management procedure" shall be implemented; if changes are required, the "change control procedure" shall be implemented; the quality problems and potential quality problems that have occurred shall be investigated and corrective and preventive measures shall be taken, and the "Corrective and Preventive Measures Procedure" shall be implemented.
Quality Management System
A comprehensive quality management system has been established, including two core parts of quality control and quality management, covering all links from raw material procurement, production process control, product inspection, storage and transportation to sales services. The quality authorized person is the person in charge of the company's quality management system and is directly responsible to the general manager of the company. Through continuous improvement and optimization, the effectiveness of the quality system is continuously improved to ensure stable and reliable drug quality.
In accordance with the requirements of GMP, detailed operating procedures and quality standards have been established to strictly control the production environment, facilities and equipment, personnel operations, material management, and documentation. At the same time, strengthen risk assessment and supplier management to ensure that potential risks in the production process are identified and controlled in a timely manner. In addition, through measures such as staff training, quality audit and continuous improvement, the perfection and effectiveness of the quality system are continuously improved to provide consumers with high-quality drugs and services.
Quality System Architecture
Central Laboratory Display
Centre Laboratory Showcase
Centre Laboratory Showcase
Centre Laboratory Showcase
Centre Laboratory Showcase