AN OVERVIEW: ROLE OF PROCESS VALIDATION IN TABLETS

Abstract

The purpose of this work is to present an introduction and general overview on process validation of pharmaceutical manufacturing process especially tablet manufacturing process. Validation is the documented act of demonstrating that a procedure, process, and activity will consistently lead to the expected results. This type of validation is based on the physics of compression. It often includes the qualification of systems and equipment. It is a requirement for good manufacturing practices and other regulatory requirements. A properly designed system will provide a high degree of assurance that every step, process, and change has been properly evaluated before its implementation. Testing a sample of a final product is not considered sufficient evidence that every product within a batch meets the required specification. Three consecutive batches of tablets shall be taken up for process validation. Based on the result of these three batches the conclusion is drawn and Batch Manufacturing Record can be written once the validation process is complete.