Is change a good thing in GMP?

Change for the better is always good, not only in GMP, but in any other matters. However, in GMP, you cannot simply change as you wished. GMP is about maintaining order and ensuring consistency in meeting the quality parameters of products. So, while some changes are genuinely good, we are not allowed to assume it as such in a GMP environment.

There are many instances whereby a manufacturer had a good start, having all utilities, equipment and processes qualified and validated. But after a period of time, product defects start to creep up and bad incidents grow in numbers. I bet you all these are mainly due to changes done by some smart guy, without proper control and approval.

As a rule of thumb, always assume change as something that is not wanted, or presenting risk to product quality. Resist change. Be on the offensive to any proposal for change. It may sound like you are a person with a 'closed mindset', but this all need to be done to safeguard the interest of GMP.

Any change proposed, be it from the from the lowest rank personnel in the organization, or from the top person (CEO), must undergo systematic scrutiny and levels of approval. This is more crucial for validated processes whereby efforts have been taken, painstakingly, to prove that the process is capable, effective, reliable and robust.

Look at the proposal for change, critically scrutinize and seek for justification before accepting it. Get the 'subject matter expert' to approve and the QA Manager to authorize the change. Plan what need to be done to get the change executed and outline procedures to ensure that the change do not affect the final quality of the product. If necessary, re-qualify (for equipment and utilites), or re-validate (for processes). NEVER TAKE CHANGE AS A MINOR ISSUE!
Most importantly, record all the actions and decisions that took place.

The change management itself must have authorized written procedure to ensure reliability and consistency in handling of changes to any part of the operation.
Any changes in the ' Change Procedure' must also undergo the same procedure before the change handling procedure is effective.
Sounds a little winding, but think carefully..... it does make sense!