Manav Bharti University,
Validation is the most recognized and important parameter of GMPs. This article provide introduction about the process validation of pharmaceutical manufacturing process and its importance according to The U.S. Food and Drug Administration (FDA). This work is to present an introduction and general overview on process validation of pharmaceutical manufacturing 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. 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.