By John Godshalk, JG BioConsult
I once was on inspection for a US Government sponsored project and I noted that the firm had no SOPs—they were all built into the batch record. It took us forever to go though the HUGE batch record. Of course, it was huge because all of the SOPs for all of the equipment were in there. The company had no SOPs for any of their equipment. Note that this was clinical trial phase production, rather than licensed production. None of the three inspectors wrote an observation for not having any SOPs—why? Because the instructions were there, in written form, just in the batch record for specifically how the equipment was being used. In my opinion, this is a poor practice, and not acceptable for licensed production—again, why?; especially because it apparently is just fine for clinical trial phase production if SOPs are all in the batch record.
“Poor practice” issues are the toughest ones to write as observations, because they are often the “c” in cGMP—more aligned with industry practice and FDA guidance documents and the like. GMPs don’t change much over time, but how they are interpreted, as guidance or as industry practice, does change. In this case, my opinion is that having an SOP is the industry standard and best practice.
Why have a separate SOP rather than have them all in the batch record? What difference does it make? A separate SOP is very useful for many reasons, including being able to train on the equipment, having a procedure for troubleshooting if needed, being more flexible as to how the equipment is used with different parameters, and having the maintenance (and possibly calibration) and cleaning procedures there in the SOP and therefore easily accessible.
As a practical point (I am a big fan of being practical!), having SOPs for all the equipment makes it easy when someone wants to remember how to use a piece of equipment, teach a new person how to use it, figure out how to clean it, perform maintenance, or the like. As an example, one of my colleagues has a freezer that is in use where the operation of it is built into the batch record with no SOP. I noted that if this freezer needed defrosting, there was no SOP to consult for how to do that. They would have to go back to the original user manual to figure it out.
So the bottom line is to create SOPs for all GMP equipment. It will likely save time and be less hassle in the long run, and also be more user friendly.