Another way to view a GMP temporary Change – Scary, isn’t it?

In my view, it is not acceptable to refer to any Change as temporary. You either Change or you don’t. It should be a well-structured and controlled Change from start to finish.

I accept, we may face exceptional situations as in the above illustration, where a very immediate fix must be made. This is an immediate action that occurs as a result of a deviation.

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Written by: Sanjay Nadarajah, GMP/GDP Consultant