Change control Req

Is change control required for a new product manufactured first time in an area?


Definitely required as new product base document trigger through change control.

An assessment is required to evaluate suitability/implications including equipment,prcocess,process validation, cleaning validation and stability requirement. This assessment will be done as a part of change control or through certain in house procedure. Of course change control is a better practice meet the requirement.



in case some other product run in the area and then run in new product in area change controle is importante or not

If any product newly introduced means you have to raise the change control and perform validation.