摘要
目的探讨药品经营企业质量方针在《药品经营质量管理规范》(GSP)管理中的重要性。方法从质量管理理论和GSP管理规定出发,根据对相关术语的理解和诠释,从质量方针与GSP管理、质量方针的制订和实施对GSP管理的影响来阐述在GSP管理中的重要意义,分析质量方针在GSP管理中的必要性与重要性。结果质量方针在2012年版GSP中占据重要位置,是GSP管理的总纲,需要围绕质量方针开展药品经营质量工作。结论质量方针的贯彻与GSP管理密切相连,说明质量方针的实施是GSP管理中最重要的一环。
Objective To investigate the drug handling enterprise quality policy in the "standards for quality control of pharmaceutical management"(GSP)the management of importance.Methods From the point of view of quality management theory and GSP management regulations,according to the relevant terms of understanding and interpretation,toexpound the important significance in GSP management from the impact of the establishment of the quality policy and GSP management,the quality policy and the implementation of GSP management,analyzes the necessity and importance of the quality policy in GSP management.Results The quality policy occupies an important position in the 2012 edition of the GSP,GSP management principles,need around the quality policy quality of drug management.Conclusion To carry out themanagement of GSP and quality policy are closely linked,to illustrate the implementation of the quality policy is the most important part in the management of GSP.
出处
《中国药物经济学》
2015年第2期184-186,共3页
China Journal of Pharmaceutical Economics