试论医院制剂质量管理的GPP模式

GPP and Hospital Pharmaceutics Control

GMP是药品生产的质量保证,鉴于医院制剂的特殊性,难能照搬,故本文依据GMP的原则提出适合医院制剂生产的GPP,以供指导医院制剂生产的管理。

Good Manufacturing Practiee(GMP) is a guarantee for superior quality in drug production. GMP should not be indiscriminately applied to the production of hospital pharmaceutics because of its peculiarities. On the basis of GMP, we propose Good Preparation Practce(GPP)to act as a guidance for control of hospital preparation production