论文部分内容阅读
GSP(《药品经营质量管理规范》)是医药经营企业的管理规范,从事药品流通、销售的企业必须经过GSP认证,被公认为是弥补漏洞,提高监管质量的重要手段。2015年6月25日,新版GSP正式实施,业界认为新版GSP的高要求和严标准对经营企业的人员、软硬件要求都比之前更高。2016年7月20日,国家食品药品监督管理总局公布《关于修改<药品经营质量管理规范>的决定》,并自公布之日起施行,其对GSP条例做了16
GSP (“Good Manufacturing Practices”) is a management code of pharmaceutical enterprises. Enterprises engaged in the circulation and sales of pharmaceutical products must be GSP certified and recognized as an important means to remedy loopholes and improve the quality of supervision. June 25, 2015, the new GSP formally implemented, the industry believes that the new GSP’s high requirements and stringent standards for the management of personnel, hardware and software requirements are higher than before. On July 20, 2016, the State Food and Drug Administration promulgated the “Decision on Amending the Code of Quality Management for Pharmaceutical Products,” which came into effect on the promulgation date. It has made 16