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Validating sampling plans

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Process validation is becoming ever more important within regulated and non-regulated industries.

Sampling plan and procedure must be defined in validation protocols and training should be provided to the concerned staff before the validation activity starts. 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.

Sample quantity should not be more than the required and whole mass of each sample should be used in analysis. Homogeneity of the blend is critical for the quality of the final product.

Second, one must demonstrate that the sampling plan allows this objective to be met.

This process will be demonstrated through a series of examples.