• Anil kumar datta
• Mrs. Sunita arya
• Ms. Gulbahar

Validation is an important part of cGMP. The meaning of validation is assessment of validity or proving action of effectiveness. It is an art of designing and practice the designed steps along with the documentation. Validation and Quality assurance will ensure the quality of product. Process validation is the important step in achieving and maintain the final product quality. This article include introduction, validation types, view product lifecycle, process validation phases, selection of CCP & CQA, Document required, VMP, process validation protocol, sampling planning study on Process validation by these mention parameters highlight the output quality of finish dose form. The main aim and objective of this work is to establish scientific evidence by collection and evaluation of data from the manufacturing of product Erythromycin estolate tablet which establish document evidence that the process is capable of providing consistently quality product and meet the pre-defined process parameters, specification and quality attributes.

Process validation, manufacturing procedure, process validation protocol, Quality, Erythromycin, Regulatory guideline

"A review on process validation of Erythromycin estolate tablet IP 500mg", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.9, Issue 1, page no.e531-e538, January-2022, Available :http://www.jetir.org/papers/JETIR2201473.pdf

"A review on process validation of Erythromycin estolate tablet IP 500mg", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.9, Issue 1, page no. ppe531-e538, January-2022, Available at : http://www.jetir.org/papers/JETIR2201473.pdf