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We establish an effective team to implement a Quality system under ICH Q7A. Two main products have been granted CEP certificates. Several European and American customers have audited our company and approved us as their suppliers of API. Several products are prepared for FDA inspection now.
QA Dept QA Dept reports to General Manager and is in charge of quality management and implementing GMP. Its size is compatible with the production needs. QA supervises all the quality-related matters. It is divided into QA and QC units.
QC Dept QC Dept analyzes raw materials, packaging materials, process water, intermediates and APIs and accumulate stability data. For tests and apparatus, refer to the content under "Analysis services".
Equipment and calibration: In charge of GMP-compliant equipment purchasing, installing, conditioning and qualification. Draft the equipment and apparatus Periodic Calibration Plan and check the status of equipment and apparatus.
Personnel Training We offer newly hired personnel training and implement continuous cGMP training program periodically to make sure the personnel are experienced. |