In Lifecome, the quality management system aims to meet customer needs and increase customer satisfaction. The QA, GMP, QC and QRM departments are the integral parts of quality management system. The top leaders and different departments are included in the quality management system. Lifecome has a life-long quality principle.
An independent quality system has been set up to realize the function of Lifecome’s quality management, which includes regulatory affairs and applied research and development. The regulatory compliance and the approval of product market access have been sped up by the complementary advantages of quality management and regulatory affairs.
Quality principle: 1. Science/Risk-based quality management 2. Scientific concepts throughout the quality management 3. Quality management facilitates the continual improvement.
The framework of Quality Management System
The company’s quality management system meets the requirements of different management departments, such as the Ministry of Agriculture of China, US FDA, Australian APVMA, European Authorities and Supplier Audit etc. In the past 5 years, the company has passed different official inspections and audits for about 20 times.
Quality Assurance(QA)
At present, there are about 1427 standard operation procedures in quality assurance department. The scientific risk analyses have been done for all the key procedures. And all the operations are strictly in compliance with the SOPs. A well-established record management and traceability system has been set up to ensure the quality assurance work goes smoothly.
Lifecome Record Management Office
The company's quality management system meets the requirements of different management departments, such as the Ministry of Agriculture of China, US FDA, Australian APVMA, European Authorities and Supplier Audit etc. In the past 6 years, the company has passed different official inspections and audits for about 20 times.
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