Abstract
Author(s): Rahul Paruchuri*, Shagun Trivedi, Gargeyi Pavuluri, Prasanthi B and Senthil Kumar M
Validation is one of the important steps in achieving and maintaining the quality of the final product. If each step of production process is validated we can assure that the final product is of the best quality. Validation of the individual steps of the processes is called the process validation. Different dosage forms have different validation protocols. Here this article concentrates to provide assurance that the manufacturing procedure is suitable for intended purpose and consistently meet predetermined specifications and quality attributes, as per specified master formula record. It also provides a documented evidence for the operation sequence and schedule of manufacturing process and to determine the critical parameters and variables in the process of manufacturing of the tablets. It gives a higher degree of assurance that the manufacturing process consistently meet the pre-determined specifications and quality products output can be used to increase productivity, its consistent quality and decreasing the need for processing/market complaints.