Procedure for Sampling in Process Validation

Sampling plays a major role in achieving the accurate results of the analysis. Sampling plan and procedure must be defined in validation protocols and training should be provided to the concerned staff before the validation activity starts.

Samples are representative of the whole batch. So it should be homogenous and should be taken properly from appropriate locations. Blend samples should be handled and weigh carefully because segregation may occur during weighing and transpiration.

Octagonal Blende

Sample quantity should not be more than the required and whole mass of each sample should be used in the analysis.

Sampling for Blend:

Blends are tested for their homogeneity. Homogeneity of the blend is critical for the quality of the final product. The sample should be taken from at least 10 locations in the blender. Sampling location should be selected according to the difficulty of the blending.

Areas of poor blending must be covered in sampling. Corners and discharge point must have sampling location. Blender geometry should be taken into consideration during the sampling of the blender.

Following are the sampling locations for octagonal blender.