The quality assurance department of Yuanhe pharmaceutical co., LTD. is the most important duties in GMP management, including the following aspects: the quality control and inspection, is under the leadership of general manager; Quality standards and all kinds of documents; Inspection with equipment management measures; Materials, intermediate products and finished products allowed to use; Nonconforming product management; For material, intermediate products and finished product sampling, inspection, retention samples, and issue the test report; Monitoring the number of dust particles and the number of microorganisms and process water in clean room (area); The assessment of the quality of raw materials, intermediate products and finished product stability, in order to determine the material storage period, offer data validity of drugs; Complaints and drug adverse reactions; Supervise production process; Review packaging sample; Supplier audit and assessment; The introspection; Process audit procedures; The issuance of batch production records; File management of technical documents; GMP training; Quality review; Change management; Risk management; Deviation management; The management of corrective and preventive actions; The establishment of the quality system of authorized person; The construction of quality guarantee system.
Quality assurance department QC checkout room area 500 m2, with physical and chemical checkout room, balance room, precise instrument room, the comprehensive measure instrument room, sample room, microorganisms room. Microbes can achieve partial measure A with a magnitude of B standard grade clean area. QC laboratory has High performance liquid chromatography, ultraviolet spectrophotometer and gas chromatograph, atomic absorption spectrophotometer, Fourier infrared spectrometer, Ion chromatograph and other international advanced testing equipment, also equipped with an automatic rotation, intelligent dissolution meter, intelligent disintegration instrument, potentiometric titration, such as conventional instruments, can completely meet the needs of we project inspection on all products.
The quality assurance department consists of quality management and QC checkout room, there are 6 quality management personnel responsible for overall quality management, including the establishment of the quality management system; there are 6 QC inspection personnel, be responsible for all materials, including disinfectant, lubricants, and products inspection and lab daily management.
Quality assurance department of Yuanhe pharmaceutical under the leadership of the company, in strict accordance with the GMP management, closely around the company's quality policy objectives, with good quality. Quality management from supplier audit, raw material procurement, production process, product inspection, product packaging, product release, sell, adverse reactions, complaints and so on, strict control each link, established a complete quality guarantee system. QC checkout room of Quality assurance department has the international advanced testing instruments and equipment, to effectively ensure the products with high quality, high efficiency, safety and health.
Company's quality assurance department is basis on personnel quality, efforts to develop quality management and quality control personnel, for the quality assurance system operating efficiently to lay a solid foundation for completely. In supplier quality audit, raw material quality, change control, deviation handling and product releasing, document control, nonconforming product processing, HACCP, CAPA, health management, authentication management, quality control, strict management, to achieve the whole process of drug production control. Quality assurance department follow the new GMP idea, make our each patient can eat the rest assured.
In the end of 2004 years our company first through the GMP certification; after the 5 years of production and operation, in October 2009 years we had pass GMP recertification; in September 2014 years we had pass GMP（the 2010 version) certification.
