Qualification of Ganscoater according to various Regulatory Guidelines: An Overview

Abstract

The main objective of this project is to define the qualification
requirements and acceptance criteria supported various regulatory
guidelines to gather sufficient data to make sure that Ganscoater Machine
is installed, qualified and use as intended within the processing
environment. Tablet coating may be a process by which an essentially
dry, outer layer of coating material is applied to the surface of a dosage
form so as to confer specific benefits over uncoated variety. It comprises
function of a sugar or polymeric coat on the tablet. The benefits of tablet
coating are taste masking, odor masking, physical and chemical
protection, protects the drug within the stomach, and to regulate its
release profile. Various sorts of coating machine is employed to coat the
tablets, in our project we've used Ganscoater Coating machine, which is
one among the simplest coating machine and widely used across
pharmaceutical industries. To use any coating machine qualification of
the machine and validation of its process is usually required before put it
into operational exercise.