Hello!
Does anybody know if is mandatory to sign on each page of POS? What are requirements ragarding this aspect for FDA regulations and for EMEA regulations.
The sign to be written is:
The author of the procedure
The verifing person
The person who aprove POS
Thanks.
SOP page signatures
8 July 2009
#1
Radel
SOP page signatures
Doesn't anybody know? Are you all in vacantion?
On the SOP's that I have seen, the signatures are all on the front page only. I'm not familiar with the FDA though.
Parvoman, I am not from US. I am from Europe, so if in UK are aproved, by your regulatory authorities, SOPs, with signatures only on the first page, so it can be in my country (Romania), as well. Afterall we are in EU and the regulatory authority in EU is EMEA. Am I right? Thanks.
Hi Radel,
The FDA does not have a requirement regarding signatures on every page, so you do not need to do that. Having said that, the FDA requires you to maintain proper documentation and prove that the SOPs are followed when used. If you can prove that without signatures then you are good. All this depends on the auditor. I've been at companies that sign every page, but most do not.
Hello!
Thank you, Ivan. We haven't been audited yet, except by our authorities. We expect though, to be inspected by EMEA one way or another. Then it will be the main task for me.
Thanks again, an keep up the good work.
Typically just one page on controlled documents (i.e., SOPs, Policies, Forms, etc.) have signatures. I've seen it usually on the first page, but some have signatures/approvals at the end. Check out some of the templates at GMPDocs.com.
Compliance documentation formats.
We received a warning letter some years back for not having our documentation (SOP's, method statements and others) under control. If signatures are only on the front sheet then front sheet must;
indicate number of sheets in document and ensure each sheet is numbered as 'Page x of xx'. It must also show the issue level of complete document. This was deemed acceptable for small documents, but not accepable for large documents where your choice would require to be supported with a written justification. Probably contained within your Corporate Quality Manual. We bought in heavily from www.validation-online.net and use their documentation templates for just about everything.
Regards
Bridge W