非无菌化学原料药工艺验证的关注点

Focus on Process Verification of Non-sterile Chemical APIs

非无菌化学原料药的工艺验证在药品生产质量管理规范(GMP)中是一项非常重要的工作,它直接关系到药品生产工艺的稳定性、可靠性和重现性。企业应结合非无菌化学原料药的工艺特殊性开展工艺验证。以期减少非无菌化学原料药工艺验证失败的风险,生产出符合预定用途和注册要求的药品,确实保障消费者的用药安全。

Process verification of non-sterile chemical raw materials is a very important work in good manufacturing practice(GMP),which is directly related to the stability,reliability and reproducibility of drug production process.Enterprises should carry out process verification according to the process particularity of non-sterile chemical raw materials,so as to reduce the risk of failure in process verification of non-sterile chemical raw materials,produce drugs that meet the intended use and registration requirements,and ensure the drug safety of consumers.