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There's quality department, directly under the leadership of General Manager, to effectively carry out quality control and inspection work during the whole process of drug production. The quality department contains quality room and center laboratory and is equipped with a certain number of quality managers and inspectors, who have more than high school education, and obtain certificate of completion.
All the raw and auxiliary materials, packaging materials, intermediate products and finished products have quality standards and test operating procedures, whose formulation and review are implemented according to prescribed procedures. Internal control standard is higher than the statutory standards.
Use of material and intermediate product is decided by quality control department.The release of finished products is eventually released after signing.
Standard products, reference substances, test organism are kept and issued by specially-assigned person and have management procedures and related records. Quality management department is responsible for sampling, testing, keeping samples of materials, intermediate products and finished products. It submits inspection report in accordance with the original data. Inspection notes and reports are pought into the batch files.
Sample keeping room is setted. Specially-assigned person are personponsible for observation, according to plan regularly reviewing the stability of materials and products study to determine the storage life of materials and validation of medicines. Quality management department assesses quality system of major material suppliers and fulfills the quality veto power. When suppliers are changed, quality management carries out the examination and approval change process.
Enterprise ascertains quality control program of raw materials used in drug production according to technic requirements, material characteristics and suppliers, quality system audit.