• Anil Dutta
• Mrs. Sunita arya
• Ms. Gulbahar

The purpose of this process validation (Process performance Qualification) of the Erythromycin Estolate Tablets IP 500 mg is to establishing documented evidence to ensure that the process is feasible and to demonstrate that the product is producing a product meeting its predetermined process parameter requirements as per predefined product and quality attribute by collection and evaluation of the data from the manufacturing of tablets specification. During the work critical material attributes, critical process parameters are checked and controlled to achieve the desired critical quality attributes. The three consecutive batches are taken to validate the process. The manufacturing of the batch is done through wet Granulation technology.

Process Validation, Process Performance Qualification, Design space, Critical material attributes, Critical Process Parameters, Critical Quality Attributes, Erythromycin, Qualification of Equipment’s.

"Process validation of erythromycin estolate tablet", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.9, Issue 7, page no.f734-f747, July-2022, Available :http://www.jetir.org/papers/JETIR2207589.pdf

"Process validation of erythromycin estolate tablet", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.9, Issue 7, page no. ppf734-f747, July-2022, Available at : http://www.jetir.org/papers/JETIR2207589.pdf