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对制药行业洁净流体工艺系统中的死角进行了准确定义,从风险评估的角度介绍了死角对洁净流体工艺系统的质量影响,并结合药典和新版GMP提出了具体的解决方案。
The dead angle in the clean fluid process system of pharmaceutical industry is precisely defined, the quality impact of dead angle on the clean fluid process system is introduced from the perspective of risk assessment, and the specific solutions are proposed according to Pharmacopoeia and the new GMP.