Vol. 4, Issue 3 (2015)

Author(s):
Monika Sharma, Shikha Agarwal, Shweta Agarwal, Manoj Sharma

Abstract:
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. Process validation also emphasizes the role of objective measures and statistical tools & analyses and emphasizes knowledge, detection, and control of variability and gives assurance on consistent of quality/productivity throughout life cycle of product. According to GMP, validation studies are essential part of GMP these are required to be done as per predefined protocols. 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. The validation study provide the accuracy, sensitivity, specificity and reproducibility of the test methods employed by the firms, shall be established and documented. Thus the validation is an essential part of the quality assurance. Lending importance to validation is increasingly profound in recent years.