Institutional and personnel management
The company has established an organization that is compatible with GMP management, and the heads of production and quality management departments do not concurrently serve each other. Head of enterprise quality, engineer, licensed pharmacist, university degree, engaged in drug management for more than 20 years. The person in charge of production, engineer, university degree, engaged in quality management of pharmaceutical production for more than 20 years.
The company set up the Quality Assurance Department, which has QA and QC and GMP offices, and is directly under the leadership of the general manager, responsible for quality monitoring and inspection of the whole process of pharmaceutical production. QA is responsible for the quality control of the whole process, the quality audit of the supplier, the supervision of the production process, the product quality complaints and the adverse reaction monitoring report; QC is responsible for the inspection of the raw materials, intermediates, finished products, process water and air cleanliness of the whole plant. And issue an inspection report form; the GMP office is responsible for self-inspection at the end of each year, and forms a self-inspection report. The defects found in the self-inspection are rectified within a time limit and the results of the rectification are tracked.
Each product has established technical procedures and standard operating procedures according to the registration process. When the revision is made, the approval procedures are carried out according to the relevant documents and relevant verification is carried out. If there are major changes to the process, the customer is notified in advance and reported to the local food and drug administration for approval. .
Batch production records are designed according to process procedures and standard operating procedures. According to the regulations, one year after the expiration date, the whole production process of the batch of products can be traced according to the production batch number, including the influence of the initial raw materials on the batch of products.
The batch number is in compliance with the requirements and has strict written regulations.