• Deerghayu Pant
• Kashif Hussain
• Praveen Kumar Ashok

Quality is the primary goal of any industry and the items it produces. The pharmaceutical business is currently interested in several perspectives on achieving such quality. Validation is the process of planning and practising the actions that will be documented. Validation and quality assurance will work in tandem to ensure the items' overall quality. Process validation focuses on process design aspects and maintaining process control during commercialization, as well as communicating that process validation is a continuous programme and aligning process validation activities with the product lifecycle. Process validation also emphasises the role of objective metrics and statistical tools and analyses, as well as understanding, identification, and control of variability, and provides assurance on product quality/productivity consistency across the product's life cycle.

Quality, Validation, Process Validation, Protocol, Prerequisites, Regulatory basis. throughout life cycle of product

"Overview of Validation and Basic Concepts of Process Validation", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.10, Issue 9, page no.c37-c50, September-2023, Available :http://www.jetir.org/papers/JETIR2309206.pdf

"Overview of Validation and Basic Concepts of Process Validation", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.10, Issue 9, page no. ppc37-c50, September-2023, Available at : http://www.jetir.org/papers/JETIR2309206.pdf