Good manufacturing practice (GMP) is that part of a quality management system to ensure that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. GMP is aimed primarily at diminishing the risks inherent in any pharmaceutical production; which may broadly be categorized into two groups: (1) cross-contamination/mix-ups and (2) false labelling. Above all, manufacturers must not place patients at risk due to inadequate safety, quality or efficacy.  For this reason, risk assessment has come to play an important role in WHO quality assurance guidelines.

良好生产规范（GMP）是质量管理体系的一部分，以确保产品的生产和控制符合适合其预期用途和市场准入要求的质量标准。GMP的主要目的是减少任何药品生产中固有的风险；其大致可分为两类：（1）交叉污染/混淆和（2）错误标记。最重要的是，制造商不得因安全性、质量或疗效不足而将患者置于危险之中。因此，风险评估在WHO指南中发挥了重要作用。

WHO good manufacturing practices