Abstract

A REVIEW ON PHARMACEUTICAL PROCESS VALIDATION

Dr. Praveen Kumar Ashok, Saurabh Pant, Gulafsha Praveen and Alan Khadka*

ABSTRACT

Validation is the most well-known and important GMP parameter. The U.S. Food and Drug Administration states that this article addresses the importance of process validation for pharmaceutical manufacturing processes and gives an overview of it (FDA). This study includes an introduction and a broad summary of the process validation of the pharmaceutical manufacturing process. Quality must be built into the product at every stage and not merely tested for at the end using quality assurance tools. The production of a drug with reproducible quality will be ensured via process validation. Process Validation is used in the pharmaceutical industry to accomplish this task as, in accordance with ISO 9000:2000, it has demonstrated to be a key instrument for qualitymanagement of pharmaceuticals. Process validation is typically carried out prior to the release of a new product, if a change is made to an existing product, and on an ongoing basis to ensure the process is working as intended. The parameters that will be monitored, the samples that will be gathered, and the outcomes that will be considered valid should all be outlined in the protocol that is created initially.

Keywords: Process validation, Quality, Protocol, Quality Management.