The life of a patient depends on the medicines he/she takes in critical situations.
If there will not be safety, efficacy, Potency & quality the patient will not be able to heal, cure and recover.
Whether you will accept that following compliance is difficult so one should not follow?
If you are manufacturing medicine for your family then whether you will make the adulterated medicine because following guidance, manufacturing good quality of medicine, doing compliance is difficult & costly?
If you have prepared, reviewed & approved the SOP then who stops the company from following that SOP?
If you want to make the change, and change control SOP is already there then who can stop from doing the changes without following the procedure?
Obviously, it's all a collective decision of the organization who are responsible for that.
So, we cannot say that company is not able to follow its own procedure. Many warning letters are given for this reason all over the world.
Yes, before approving SOP the requirements which must be there to follow must be in place. That is to be ensured before the SOP is effective.
If the Regulatory Inspection is there, whether Auditor will accept the justification that it is difficult to follow the guidelines so we did not follow it?
To overcome all the issues at the last moment we will have to act as if every day is an audit.
That thought process I have elaborated in my book " Blue Ocean of Compliance".
Click the below link to book your copy;
Whoever chooses the wrong path, the whole organization has to pay for that.
What I think is that it's not that companies are not able to follow compliance.
Yes, there is a cost of everything one has to pay, that's the reason there is a difference in the cost of material, medicines that are Regulatory Complied & which do not claim for any specific Regulatory Compliance.
By the way, nothing is free in this world.
There are companies who qualify the audit with no observation and there are companies who got warning letters.
I think different approaches have different results.