Change control format

How can make change control effectiveness for Pharma Customer ??

Please clarify your question precisely.

Suppose, We are adding new machine in our plant. how will make change control ? what is point to be add in change control ??


I’m sorry if this sounds rude, but I can only offer a general reply to a general question like this; hope it helps:

One of the main purposes of a change control is to identify all potential risks involved in that change, and mitigate them so the change does not put any other element at risk. That being said, the basic elements of your CC might include at least:

  • Description of the change ( what’s the current status, and what is pursued with this change)
  • Risk assesment (identify all potential risks involved with the change and evaluate them)
  • Action plan (including step by step all actions to be taken to make the change including actions to mitiage risks identified during RA)

existing procedure shall be NA.
Proposed system. New machine to be installed for …( which machine you have )
Justification. For increase prodctivity