实施GMP的三大目标要素之一就是要建立健全制药企业的质量体系 (另两个是防止污染及交叉污染、防止差错 )。制药企业的质量体系是为了保证全面正确贯彻实施GMP而建立的 ,是站在系统的高度对企业的质量管理的多方面工作进行优化和规范。质量体系要依靠质量审核来评估体系的有效 One of the three major target elements of implementing GMP is to establish and improve the quality system of pharmaceutical companies (the other two are to prevent pollution and cross-contamination and prevent mistakes). The quality system of pharmaceutical enterprises is established to guarantee the full and correct implementation of GMP. It is to optimize and standardize the multifaceted work of quality management of enterprises from a systematic perspective. Quality system to rely on quality audits to assess the effectiveness of the system