Writing SOPs and Policies

[Orr]

Does anyone know of specific guidance and references in GMP for writing SOPs ?

We have confused staff who think these documents need to be 30+ pages long to be “ISO compliant”, regardless of these becoming unreadable. Did ISO replace common sense?

Perhaps we need to consider a new sub category for human errors- staff unable to follow the procedure due to boredom.

Any urgent help would be really appreciated.

Thanks!

[a123456]

The Research Quality Association (a not for profit professional membership organisation) runs many courses on GMP and writing SOPs and other aspects of QSM. Might be worth a look. www.theRQA.com

[Orr]

Thanks for the info.

I suppose the following GMP reference could also be mentioned :

GMP 4.4 Documents containing instructions should be laid out in an orderly fashion and be easy to check. The style and language of documents should fit with their intended use. Standard Operating Procedures, Work Instructions and Methods should be written in an imperative mandatory style.

It is really about making sure new SOPs/ Policies are easy to read and understand by staff. Having information written as text book chapters isn't helpful- and also contributes to the amount of time taken to write these unnecessarily long documents, that are of little benefit to anyone.