药品生产质量管理规范验证对医院制剂的影响

摘要

With the rapid development of medicine technology and pharmaceutical industry , the law and regulations on drugs and their supervision system are being perfected gradually . Pharmaceutical preparation in the hospital is confronted with even more challenges, as in the preparation process and inspection condition . More and more importance has to be attached to the implementation of good manufacturing practice validation in order to promote the development of pharmaceutical preparation in the hospital in accord -ance with the new law and regulations.%随着医药科技和制药工业的飞速发展,药品法规及其监督机制的不断完善,医院制剂的发展正面临着更多的挑战,其配制工艺和检测条件的要求也越来越高.为了适应新形势下的药品法规,进一步发展医院制剂,药品生产质量管理规范(good manufancturing practice,GMP)验证的推行显得尤为重要,以不断提高医院制剂的质量,充分补充医药市场上的品种供应,全面服务于临床,更好地满足医院医疗用药的需求.