Importance of change control:

Change control is very important part of the quality system in pharma industry.

Without change control system one can not the track the changes done in system by the department; that change may be unauthorized or violent hence it important to document the changes:

Following are the reason why change control is important in pharma:

To prevent unauthorized change to established systems/procedures:

Change should not be against the GMP and it should be properly justified hence it need to be approved by QA and properly documented.

  

To identify changes and carefully evaluate and assess their potential impact:

The proposed change should b properly evaluated it may be directly or indirectly impacted on the quality of the system it should not adversely impacted on the quality so evaluation should be properly done before implementation of change.

To inform to impacted department, perform impacted activity and revise any affected documents:

If any documents, activity or department is impacted due to the changes. For example if you want to replace the reactor it impact the production, engineering safety department.

To perform the impacted Activity and revise the impacted documents  by concern department :

As we discussed in previous point other department also impacted due to the one change in to the system due to the that changes concern department also have to perform impacted activity and documents .