On December 24, 2014 to 27, the Jiangsu provincial food and Drug Administration Center certification review appointed 4 person inspection team to Yancheng Su Hai Pharmaceutical Co., Ltd. doxycycline hydrochloride were "drug production quality management standards (2010 Revision)" (hereinafter referred to as: the new version of GMP certification on-site inspection). Yancheng City food and drug supervision and Management Bureau has appointed an observer accompanied inspection. After three days of intense work, the inspection group according to the new version of GMP and raw material medicine stated in the appendix, focus on quality management, organization and personnel, buildings and facilities, equipment, materials and products, verification and validation, file management, production management, quality control and quality assurance, product delivery and recall, self and other elements of the scene check and review of documents, and according to the details of the work on-the-spot inquiry. Through careful, careful examination, inspection group considers that: the organization of our company is perfect, technical management personnel in place; production and testing facilities meet the needs of the production of varieties, production, material and product management to meet the requirements; establish a change control, deviation handling, OOS, CAPA, risk management, annual product quality review quality management system, and the key data trend analysis. The on-site inspection found no serious defects and the main defects, found 8 general defects, the inspection team suggested by on-site inspection.
This check is Yancheng Su Hai pharmaceutical limited company GMP certification examination, is my company relocated reconstruction implementation test inspection requirements of the new version of GMP. Passed the examination will continue the doxycycline hydrochloride product passes in the domestic market, has laid a solid foundation for the products to further expand domestic and foreign markets.
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