Abstract Validation is an integral part of quality assurance; it involves the systematic study of systems, facilities and processes aimed at determining whether they perform their intended functions adequately and consistently as specified. A validated process is one which has been demonstrated to provide a high degree of assurance that uniform batches will be produced which meet the required specifications and has therefore been formally approved. Validation in itself does not improve processes but confirms that the processes have been properly developed and are under control. Process validation deepens the understanding of processes; decreases the risk of preventing problems and thus assures the smooth running of the process.
Keywords Prospective Process validation, Extended release tablets, Qualification, Documentation, Sampling, Control Variables.