公司的質(zhì)量管理機(jī)構(gòu)為質(zhì)量部， 部長為蔡勛友，質(zhì)量部下設(shè)質(zhì)量保證和質(zhì)量控制二個(gè)部門，負(fù)責(zé)藥品生產(chǎn)全過程的質(zhì)量管理和檢驗(yàn)。
公司質(zhì)量管理執(zhí)行質(zhì)量受權(quán)人制度，質(zhì)量受權(quán)人為張國全(省局已備案）。
質(zhì)量受權(quán)人的工作不受企業(yè)負(fù)責(zé)人和其他人員的干擾，獨(dú)立行使過程監(jiān)督權(quán)；成品放行權(quán)及質(zhì)量否決權(quán)。
The company's quality management organization is the quality department, and the minister is Cai Xunyou. The quality department
consists of two departments: quality assurance(QA) and quality control(QC), which are responsible for the quality management and inspection
of the whole process of drug production.
The quality management of the company implements the quality authorized person system, and the quality authorized person is Zhang
Guoquan( He has been put on record by Hunan Food and Drug Administration).
The work of the quality authorized person shall not be interfered by the person in charge of the enterprise and other personnel, and shall independently exercise the power of supervision, the right of release of finished products and the right of quality veto.
生產(chǎn)過程嚴(yán)格按照GMP的要求進(jìn)行生產(chǎn)管理；
每個(gè)原料均制定了生產(chǎn)工藝規(guī)程及關(guān)鍵生產(chǎn)工序的質(zhì)量控制點(diǎn)，崗位SOP和崗位操作記錄；
生產(chǎn)操作前，嚴(yán)格按照要求對(duì)生產(chǎn)現(xiàn)場、工藝衛(wèi)生、設(shè)備狀況等進(jìn)行檢查，符合要求后才能進(jìn)行生產(chǎn)；
Production procedure is strictly managed according to GMP requirements.
Each API has formulated production procedure regulations and key quality control points ,SOP and operation records.
Before production , inspect production field, sanitary condition, equipment condition, Only above that meeting the requirements can carry out production.
生產(chǎn)的全過程嚴(yán)格執(zhí)行工藝規(guī)程、崗位操作SOP；
生產(chǎn)過程嚴(yán)格按照工藝、質(zhì)量控制要點(diǎn)進(jìn)行監(jiān)控，對(duì)稱量和投料實(shí)行復(fù)核制，及時(shí)預(yù)防、發(fā)現(xiàn)和消除事故差錯(cuò)；
嚴(yán)把中間產(chǎn)品質(zhì)量，做到不合格中間體不得流入下道工序；
公司制訂了返工、重新加工的管理制度；
The whole procedure of production strictly carry out procedure regulations and operation SOP.
The production procedure is strictly monitored according to the key points of procedure and quality control, and Checked the material of Weighing, Volume, Feeding ect. to avoid errors.
The company has formulated the management system of Product rework and remachine procedure.
公司制定了完善的物料驗(yàn)收、貯存、待驗(yàn)、取樣、發(fā)放、退庫管理制度。
公司建立了不合格品管理制度，確保不合格的原輔料、包裝材料不投入生產(chǎn)，不合格成品不出廠銷售，不合格的中間產(chǎn)品不流入下道工序。
建立有產(chǎn)品拼箱管理規(guī)程。
The company has formulated a Perfect management system Include material acceptance, storage, testing, sampling, granting, Return to Warehouse.
The company has established a management system of unqualified products to ensure that unqualified raw materials and packaging materials are not put into production, unqualified end products are not sold out, anunqualified intermediate products do
not flow into the next production procedure.
Establishment of management rules for product assembly.