The Role of Internal GMP Auditing in CI-Part I

A Pharmaceutical Quality Management System should do more than just ensure only quality products go out the door. It should also be a vehicle for continuous improvement. In today’s economy, any organization that does not continually improve, is rapidly dying. Even we are not immune. So what does this mean for the Internal GMP Auditor? We are (or at least should be) at the forefront of the continuous improvement methodology.

There are many ways GMP Auditors can become a valuable tool for continuous improvement. There are six sub-categories to demonstrate the various roles of the GMP Auditor, and how these roles support the organization’s continuous improvement efforts.

  1. Ears
  2. Eyes
  3. Mouth
  4. Hands
  5. Feet
  6. Back

Let’s explore each of these in greater detail.


I put ears first because they are the most important of the above. It is with our ears that we hear of opportunities for improvement. We often hear workers grumbling and complaining. Some, it seems, do little but complain. But have you ever really considered their gripes? In many cases you can learn a lot from really listening to them. They may over exaggerate, embellish, or even arrive at the wrong conclusions, but often there is some real opportunities in there.

… To Be Continued