Yes. The example is a change. But how the change is handled is subject to definition within the
company. The example is a material change that might have an impact on the quality, or not. The
Expert Working Group tried to build in the maximum freedom. It’s now up to the companies to
define the best way to handle it.
You have to deal with all changes, but not all changes have to be discussed by a committee
consisting of people from the quality unit, registration department, marketing department, drug
product manufacturing and so on. Then within the system you have to identify at which level
certain departments are going to get involved.
