Any formulation having the Active Pharmaceutical Ingredient.
And this API manufacturing is having KSM.
Now if you will do any change in the KSM then it's obviously going to have an impact on API as well as on the product.
If you will do any change in any process, or procedure without knowing its impact on the Formulation/API
then how you will know that the changes come under which category?
If you do not follow the procedure of your QMS then how you will know how is this change going to impact the formulation/API and
whether from a Regulatory point of view, this will come in CBE, CBE30, or PAS?
And how you will know how it will have an impact on your business in the future?
If you do not follow the QMS procedure then how you will conclude about its impact from other department's angle or their point of view?
Let me tell you the truth that you won't.
So, while you do any change you must follow the QMS procedure of your company as per the regulatory guidance.
I read in WL of 2022 Observation was "Failure to evaluate the potential effect that changes may have on the quality of your intermediates and API."
The reason was 1. The acceptable limit of XYZ increased in API and KSM without proper study.
This is an example of the impact of doing change without studying the impact and following QMS & guidance.
This is applicable everywhere not only in API but in Formulation also.
So what do you conclude?
You will get many such learnings in my upcoming book Blue Ocean of Compliance.