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It is a common concept in pharmaceuticals to validate three consecutive batches. In process validation, initial three batches are taken for validation. It is a fundamental question that focuses everyone’s mind that why three batches are taken for validation?
Neither the FDA nor any other regulation specifies the maximum number of batches to be considered valid. Manufacturers have to select the batch number to be verified in this regard.
The number of batches taken under validation depends on the risk involved in the manufacturing process.
Less knowledge of the process requires more statistical data to ensure consistent performance. Consideration of validation batches of less than three will require more statistical and scientific data to demonstrate process consistency to meet quality standards.
FDA’s “Industry Guidance for Process Validation: General Principles and Practices” provides guidance for process validation, no longer deeming the traditional three-batch validation appropriate but does not specify the number of batches to validate or any other method for determining it. does not advise
Generally, first batch we get desired quality is accidental, second batch is quality control and third batch is quality validation. When two batches are taken as validation data will not be sufficient to evaluate and prove reproducibility because statistical evaluation cannot be done at two points, it requires a minimum of three points because two points always draw a straight line.
Therefore, a minimum of three consecutive batches are evaluated for validation of the manufacturing process and cleaning method. Validation can take more than three batches but it involves cost and time and companies don’t want to do that.
