轻微偏差(Minor Deviations):非关键或主要偏差,对产品质量、纯净性`优尔^文*论|文\网www.youerw.com、安全性、有效性等没有影响,但对GMP体系、公用系统、设备、物料、环境、文件等有潜在影响的偏差。
Correction: Action to eliminate a detected non conformity.
更正措施(Correction):为消除已发现的不符合所采取的措施。
Corrective action :Action to eliminate the cause of a detected non conformity or other undesirable situation in order to prevent its recurrence.
纠正措施(Corrective action):为消除导致已发现的不符合的原因或其他可能导致该不符合的原因,防止其重复发生而采取的措施。
Preventive action: Action to eliminate the cause of a potential non conformity or other undesirable potential situation in order to prevent its occurrence.
预防措施(Preventive action):为消除导致该类潜在的不符合的原因或其他可能导致该类潜在的不符合的原因,防止该类潜在的不符合发生而采取的措施。