Overview of Validation and Basic Concepts of Process Validation
Journal Title: Scholars Academic Journal of Pharmacy - Year 2014, Vol 3, Issue 2
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. Keywords: Quality, Validation, Process Validation, Protocol, Prerequisites, Regulatory basis.
Authors and Affiliations
Dr. Keyur B. Ahir, Khushboo D. Singh, Sushma P. Yadav, Hetal S. Patel, Chetan B. Poyahari
Keywords
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