Change management system is a part of Good Manufacturing Practices quality management system and USFDA as well as WHO Guidelines clearly mention that a pharmaceutical company must have a change management system.
As per the USFDA WHO Guidelines, it's required that a product should be manufactured in a Manufacturing facility which comply with cGMP guidelines apart from it meeting it's specifications and standards and shelf-life.
These guidelines mention that a pharmaceutical manufacturing company must have a system to manage change, changes may be planned or may be required to do due to its Requirments.
Any change that is done in operation, Technical corporate management level Corporate QA level as well as plant level must be managed through change management system. Of
A change management system consists of a standard operating procedure for managing change in a pharmaceutical company.
It consists of a Chanage Request Format, which is also called as change control.
A change control format is required to be filled by doer or department which want to make a change. During filing the change control it is required to mention the impact of the change.
Reason for doing change. Condition before change. Expected outcome after change.
Benefits after change and espected risks as well are required to mentioned.
In event of the risks are overwheighing the benifit a change request is rejected.
A change request form must elaborate and evaluate the impact of change on all aspects of drug manufacturing. Which called as impact analysis.
Impact on Labling and Storage condition and artwork after
