Change control Req

Production
1

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

2

Definitely,

3

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

4

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.

2 Likes
5

thanks

6

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

7

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