Abstract

OVERVIEW OF VALIDATION AND BASICS CONCEPTS OF PROCESS VALIDATION

Khushbu G. Rahangdale*, Mrunali P. Patle, Neha V. Kumbhalwar, Tulanjali B. Thakre, Namrata S. Vaishnav, Nisha C. Pardhi and Sachin R. Patle

ABSTRACT

Quality is the primordial intention to any industry and its products manufactured. Multiple views on obtaining such quality are the current interest in the pharmaceutical industry. Validation is the art of designing and practicing the designed steps alongside with the documentation. Validation and quality assurance will go hand in hand, ensuring the through quality for the products. Process Validation emphasize on process design elements and maintaining process control during commercialization and communicate that process validation is an ongoing program and align process validation activities with product lifecycle. Process validation also emphasizes the role of objective measures and statistical tools and analyses and emphasizes knowledge, detection, and control of variability and gives assurance on consistent of quality/productivity throughout life cycle of product. Process validation also emphasizes the role of objective measures and statistical tools and analyses and emphasizes knowledge, detection, and control of variability and gives assurance on consistent of quality/productivity throughout life cycle of product additionally a view of validation against the quality assurance, drug development and manufacturing process has been discussed.

Keywords: Quality, Validation, Process Validation, Protocol, Prerequisite.