Deviation refers to any situation that deviates from the approved procedure (guidance document) or standard. Such as, the inspection results of raw materials or products exceed the standards, the storage of products is abnormal, equipment failures, the results of calibration exceed the standards, and environmental monitoring results exceed the standards, production process abnormalities, and other unexpected deviations from the results of drug-related regulations or approved standards and procedures.
According to the impact degree on product quality, deviation can be divided into two grades: secondary deviation and major deviation.
It refers to the deviation from procedures or standards that occur during the whole process of drug production quality management, which has no potential impact on product quality. It includes, but not limited to, the following:
Material, equipment and room status labels are not changed in time or correctly identified.
The certified instruments and meters are not replaced with qualified labels before they are put into use.
The outer package of the raw and auxiliary materials is damaged, but the inner package is intact.
It refers to the deviation from procedures or standards that occur during the whole process of drug production quality management, which may or have affected the quality of the product. It includes, but not limited to, the following:
The key process parameters control in the production process exceeds the prescribed scope.
It directly leads to major faults of production equipment; the important equipment of the process water system fails to operate.
Laboratory equipment failure;
The certified out-of-specification results (OO S).
It is found that the identified weight of the material is not consistent with the actual situation during the production process.
The instruments and meters that exceed the validity period are in use.
The inner package of raw materials is damaged during the production process.
Stability test is not carried out according to the specified time limit.
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