A Review on Pharmaceutical Validation and Its Implications

Abstract

The process validation is establishing documented evidence which provides high degree of assurance that a specific process consistently produces a product meeting its predetermined specifications and quality characteristic. According to GMP validation studies are essential part of GMP these are required to be done as per predefined protocols. The validation study provides 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.