About Author: R. C. PATEL, C. K. BHUVA, MR. R. P. SINGH, MR. ABHISHEK DADHICH, MR. ANIL SHARMA.
Department of Quality Assurance, Gyan Vihar School of pharmacy,
Suresh Gyan Vihar University,
Jaipur, Rajasthan, India-302025
Reference ID: PHARMATUTOR-ART-1053
Abstract
Validation has become one of the pharmaceutical industry’s most recognized and discussed subjects. It is a critical success factor in product approval and ongoing commercialization. This article provide brief introduction about the pharmaceutical process validation and its importance according to regulatory provision, also provide the answer of question like why to do, when to do and how to do it. This work is to present an introduction and general overview on process validation of pharmaceutical manufacturing process. Quality is always an imperative prerequisite when we consider any product. Therefore, drugs must be manufactured to the highest quality levels. End-product testing by itself does not guarantee the quality of the product. Quality assurance techniques must be used to build the quality into the product at every step and not just tested for at the end. In pharmaceutical industry, Process Validation performs this task to build the quality into the product because according to ISO 9000:2000, it had proven to be an important tool for quality management of pharmaceuticals.