Sheelpriya Ratnakar Walde
Gurunanak College of Pharmacy, India
Title: Pharmaceutical process validation: A tool for pharmaceutical compliance monitor
Biography
Biography: Sheelpriya Ratnakar Walde
Abstract
The process validation is applicable to any aspect of operation that may affect the quality of the pharmaceutical product either directly or indirectly. The primary goal of the validation process in the pharmaceutical industry is to have documented proof that quality is part of each and every step of the manufacturing and distribution system, instead of merely testing products at the end of the process. Quality cannot be ensured by sampling, testing, release of materials and products. Quality assurance techniques must be used to build the quality into the product at every step and not just tested for at the end. Process validation of a process will ensure production of drug of reproducible quality. This presentation explores the concept of pharmaceutical process validation in monitoring the various in process variable which help in assuring the quality of pharmaceutical formulation.