某原料药质量控制实验室设计简介

Introduction of Design of Quality Control Laboratory for an Active Pharmaceutical Ingredient

本文根据相关法规要求,对某原料药质量控制实验室的设计原则与布局进行了简要介绍,分区对理化控制室与微生物控制室进行了布局阐述,包括设计思路、排风系统、风险控制等因素,为现代化质量控制实验室的设计提供了参考依据。

According to relevant regulations, this paper briefly introduces the design and layout principles of quality control laboratory for an active pharmaceutical ingredient. In this paper, we describe the layout of the physics and chemistry laboratory and microbiology laboratory respectively, including design ideas, exhaust system, risk control and other factors, and provide reference for the design of modern quality control laboratory.