Hello all,
I work for a Pharmaceutical company and looking for examples of SOP for SOPs. I have one but I want to modifiy where each dept. has there own QA associate who would be responsible for maintaining there own copy of SOP and keeping the versions uptodate.
SOP for all the other SOPs on how to write them what the format and numbering system would be. How SOPs would get approved and reviewed. Who all will be trained on these SOPs extra..
You could address these issues in two separate SOPs - one, an SOP on how to write SOPs and a second for document management - as it sounds like you have elements of both in your question.
In my previous employment, where we had ISO for the entire company, and then 4 other department-specific quality programs (one for 17025, one for compliance with a Certificate of Approval, one to have Certificates of Authorization and one for Engineering... don't ask - but they were all necessary!) - we had a general document management procedure that detailed how the ISO QMS procedures/forms were managed, with an more specific procedure that got into nomenclature, revision tracking, approvals etc.. Then, each department-specific quality manual either referenced the corporate procedures (if applicable) or had an even more specific procedure - an SOP on how to write an SOP! This one was very detailed indicating things like:
- title page layout
- procedure numbering
- heading numbering
- font style, font size
- line spacing, margins, borders
- section headings (i.e. 1. Purpose, 2. Safety, 3. Responsibilities, 4. Procedure specifics, 5. Related Documents and Records)
- review frequency and approvals
- how to make changes (we allowed red pen changes to working copies, with any red pen changes incorporated into a full revision/reissue annually)
- who's responsible for "field copies", including incorporating changes etc.
Hope this helps - just my
!
Darlene