Three consecutive batches for #processvalidation in manufacturing. In the pharmaceutical industry, validation of manufacturing processes is crucial for ensuring #reliability and #consistency. The ideal approach is to perform validation on three consecutive batches

The significance of three batches lies in the statistical and the scientific data obtained. - Generally, it is considered that if we get the desired quality in the first batch, it is accidental. - The second batch provides regulatory insights. It is the third batch that validates the consistency of the process, assuring the desired #quality standards. Taking fewer than three batches for validation requires additional statistical and scientific data to demonstrate process consistency and reliability. At ITICO Pharma we strictly adhere to the three-batch process #validation approach to ensure we are delivering reliable, efficient and high-quality products.