RE: RE: RE: SOP writing Contribution from M Murphy written on 7/28/2008 at 13:01
Original contribution: RE: RE: SOP writing written by Deepan Pandya on 7/9/2008 at 19:29) I'm afraid that I find it necessary to disagree very strongly with Deepan's comments.
The EU GMP guidelines have never been as specific as to state that it is necessary to sign each and every page of a procedure. GMP requirements require you to have adequate control systems in place that prevent errors and mix-ups by using incorrect instructions or documents.
Quoting from the MHRA published 'Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2007' - Documents should be approved, signed and dated by appropriate and authorised persons - there is no requirement for the number of signatures required in order to make a document effective, it is generally accepted that three is a good compromise.
The guidelines go on to state - Documents should be regularly reviewed and kept up-to-date. When a document has been revised, systems should be operated to prevent inadvertent use of superseded documents - so long as the systems that you have in place provide adequate control, you should not have any issues. Most companies that I have dealt with operate a system of master documents and controlled copies as previously suggested by JD Mallet.
Generally the systems that I have seen assign a unique reference number and revision number to a document and apply this reference number and revision number along with the document title and a page x of y reference to the header or footer or a combination of both. This ensures that a multiple page document can be easily identified as having all pages available or missing pages as appropriate. Controlled copies that I have come across would use a combination of coloured stamps and/or coloured paper to distinguish them from normal working documents.
In summary, GMP rules and guidelines will not tell you exactly how to do it, just so long as the controls are in place and you can prove that they work.
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