Referencing other documents in protocols

I prefer to reference other pre-existing SOPs and forms in my protocol for executing tests, if available.

If a solution is required for testing and an SOP/WI exits for creating that solution, I would say create solution following SOP/WI XXX.

If doing cleaning verification my test protocol would say swab the tank per SOP XXX (the SOP that details how to take a swab sample) and submit to QC along with Form XXX (the QC form for submitting swab samples).

I’ve used batch records when doing media holds and often during a PQ I will list setpoints for the equipment but will write to operate the equipment following the approved related SOP (and then they will have to list which SOP they are following).

I think this makes the protocols lighter in that I don’t have to rewrite a procedure that already exits as well as make sure that the test was carried out in validation as it might in the field. My new colleagues disagree and think that this is not industry standard and that protocols must be a one-stop-shop. I was curious how others felt about this.


Good evening,

In my opinion there is no issue in giving reference no. of controlled procedures [Revisiona Controlled Nos.] while writing protocols to avoid duplicacy. One thing which you need to ensure that should have a controlled procedure for preserving all the revisonal controlled standard procedures [As & when required to retrive].

Happy Reading !

Dear Heathem,
Its no problem to give reference of related SOPs in Protocols , I suggest to keep the Flow Diagramme (Flow Chart only, not whole lengthy textful procedure) of related Procedures with protocols as controlled annexure to solve this problem of making protocol one-stop-shop as well as well referenced with SOP. the annexure showing Process Flow will be the annexure of that concerned SOP.

Abhishek Raval
CQA- Executive