Abstract

PROCESS VALIDATION OF SOLID DOSAGE FORM

Mahajan Harshal D*, Kawathe Sagar R, Kachave Ramanlal N, Salunkhe Kishor S,Chaudhari Sanjay R

Abstract

The goal of quality system is to consistently produce products that are suitable for their intended use. Quality is the primordial intention to any industry and its products manufactured. Multiple views on obtaining such quality are the current interest in the pharmaceutical industry. It is establishing documented evidence that a process does what it purports to do, base on information generated during actual implementation of the process. In process monitoring of critical processing steps and end product testing of current production is involved in concurrent validation. Validation is the art of designing and practicing the designed steps alongside with the documentation. Solid dosage forms include tablets and capsules. Validation and quality assurance will go hand in hand, ensuring the through quality for the products. Hence, an emphasis made on to review that gives a detailed, overview of validation concept of designing, organizing and conducting validation trials. Despite the ongoing development of more sophisticated solid drug delivery system, tablets are still by far the most prevalent solid dosage form. Additionally a view of validation against the quality assurance, drug development and manufacturing process has been discussed.

Keywords: Quality, process validation, quality assurance, consistency.