PHARMACEUTICAL PROCESS VALIDATION OF SOLID ORAL DOSAGE FORM (TABLET): AN OVERVIEW

Abstract

In Pharmaceutical organization, a validation is a fundamental segment that supports the company commitment to Quality Assurance. The purpose of this article is to present an introduction and general overview on process validation of pharmaceutical manufacturing process especially tablet manufacturing process. Validation is the documented verification that a procedure, process, and activity will consistently lead to the predetermined specific 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 cGMP 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 on 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.