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自我国正式颁布《药品生产质量管理规范》（ＧＭＰ）以来，ＧＭＰ已成为制药企业管理的规范性法规，也是现代企业推行全面质量管理的主要依据，必须认真贯彻执行。随着ＧＭＰ的贯彻伴随而来的是必须建立一整套管理软件（ＳＯＰ）。只有这样，才能走出过去那种不规范的管理模式
Since our country officially promulgated the “GMP for pharmaceutical production” (GMP), GMP has become the normative regulation for the management of pharmaceutical companies, and it is also the main basis for modern enterprises to implement total quality management, and must be implemented conscientiously. With the implementation of GMP, it is necessary to establish a set of management software (SOP). Only in this way can we get out of the non-standard management model of the past.