Proper

Abstract

This document describes the industrial operations in biopharmaceutical companies which are to be in inline with good manufacturing practices (GMP) for the production of various biologics/vaccines. It makes available guidance and how to handle the change management in GMP environment. Change management start from initiation of changes from the user with appropriate reason and justification. The same will be reviewed by user department head. After allotting the number, QA will comment about initial requirements after onwards impact assessment to be performed by user department along with QA and classification to be carried out. Later QA personnel identify several cross functional teams (CFT’s) to comment on proposed changes where the changes are impacting. After reviewing the cross functional team comments, QA will propose the action plan to be followed. Post to this, all cross functional teams which involve initially in change management review will give their approval and followed by QA for implementation. Post to the implementation, post implementation assessment (PIA) will be carried out by user department upon QA request if required and same to be documented. This is the first review over the quality systems followed in different organizations on change management.