Vol. 1, Issue 7 (2012)

Author(s):
Pankaj Verma*, N.V. Satheesh Madhav, Vinay kr Gupta

Abstract:
The process validation is establishing documented evidence which provides high digree on assurance that a specific process consistly produced 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 minimum that should be validated include process, testing and cleaning as a result such control procedure stablish to monitor the output and validation of manufacturing processes that may be responsible for variability of drug product. 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 quality assurance.