Good Laboratory Practice for Nonclinical Laboratory Studies

United States · Last verified: 2026-09-08

Number

21 CFR 58

Type

Regulation

Issuer

U.S. FDA

Status

in_force

Authority

FDA / CDRH

What this covers

GLP 非临床实验室研究质量管理规范：涵盖组织与人员、设施、设备、运行、受试与对照品、试验方案与实施、记录报告与合规检查；器械生物学评价等非临床安全性研究适用。

Source: U.S. Food and Drug Administration (public domain)