Updated: Jun 26
Every pharma company has a well-established Change control system with the related system, SOP etc. But is that the best platform to control the changes every time?
Let's think about the pharma changes for a while. What runs through our minds? - endless discussions about need to submit regulatory documentation, to decide on validation, qualification - however it seemed a good quick&easy change to implement.
What goes wrong? Is it the stubborness of QA? Is it the cautiousness of RA? the meticulousness of EHS? the hesitation of management?
No, I think :)
It is choosing a bad platform for a good cause.
All is about controlling the change. If you have the necessary control points in your home-built change process, you don't need the 'big' change control system to limit your efficiency to implement a change.
Do you have frequent changes in your process or system without any RA/QA/EHS topic to implement? - go & establish a handmade change control system for yourself.
Do you have a minor change to implement to correct a compliance gap? Just issue a risk assessment document, or just update the procedure describing the process, highlighting the change in the version history.
Any clever solution is great, as long as you have the real control on your changes. Of courst, don't forget to check in the regulations where QA pre- or post-approval is needed. The best solution if to make QA approve your SOP/work instruction where you describe your change process, that's how you get your process vetted.