PROCESS VALIDATION OF SOLID DOSAGE FORM
Mahajan Harshal D*, Kawathe Sagar R, Kachave Ramanlal N, Salunkhe Kishor S, Chaudhari Sanjay R
Journal Title:World Journal of Pharmaceutical Research
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.