An Overview of Concept of Pharmaceutical Validation Raul Saroj Kumar*, Padhy Gopal Krishna, Mahapatra Anjan Kumar, Charan Soudamini Alekha Maharajah's College of Pharmacy, Phoolbaugh, Vizianagaram, Andhra Pradesh, India *Corresponding Author E-mail: saroj.raul@rediffmail.com
Online published on 22 October, 2014. Abstract Drugs are the most important elements in healthcare and must be manufactured to the highest quality levels. Multiple views on obtaining such quality are the current interest in the pharmaceutical industry. Process validation performs this task ensuring that the process does what it purports to do. The process validation is establishing documented evidence which provides high degree on assurance that a specific process consistently produced a product meeting its predetermined specifications and quality characteristic. Validation is the art of designing and practicing the designed steps alongside with the documentation. 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. According to GMP validation studies are essential part of GMP and required to be done as per predefined protocols. 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. Thus the validation is an essential part of the quality assurance. Lending importance to validation is increasingly profound in recent years. Hence, an emphasis made on this review that gives a detailed, overview of process validation concept Top Keywords Pharmaceutical Validation, Quality Assurance, Protocol, Validation Master Plan, Revalidation. Top |