FDA 法规要求

FDA 法规要求

FDA-Guidance for Industry: Sterile Drug Products produced by Aseptic Processing – Current Good Manufacturing Practice：

Routinely used disinfectants should be effective against the normal microbiological vegetative flora. 用于日常消毒的消毒剂应该能有效杀灭常见的微生物繁殖体。

A sound disinfectant program includes a sporicidal agent used according to a written schedule and when environmental data suggest the presence of sporeforming organisms.
一个合理的消毒方案应该包含灭菌剂（杀孢子剂）的使用计划，尤其当环境中监测到有芽孢菌存在的情况下。

Section X. Laboratory Controls: Sanitization Efficacy (4): The suitability, efficacy, and limitations of sanitization agents and procedures should be assessed. 第 X部分，化验室控制：杀菌有效性（4）：灭菌剂的稳定性、有效性和局限性及程序应进行评估。