I just wanted to get some feed back from other professional across the globe on how they currently handle extra blank spaces whether in protocols or other pharama documentation. From mine experience, say if you don’t use a whole chart or a page for some reason you would just draw a diagonal line write N/A and initial and date it. Correct? Or if you’re filling out a training sheet and you have extra space left over you would just do the same thing, draw a diagonal line N/A initial and date?
Would I be correct to say that this is the current industry practice?
Yes in my experience this is the way blanks are treated and I have worked in over 12 different organizations at this stage.
I have developed a new strategy for documents I create for Premier Validation, what I do is, include a check box on each page with the title “Check Box if Page is Not Applicable” so this allows a tick in the checkbox instead of N/A-ing endless pages.
It mightn’t be everyone’s cup of tea but I am a believer in leaning down our documents as much as possible.
Hi, The practice of writing as N/A is acceptable for regulators too, provided it is defined some where in the operational documensts, other wise people may some time confuse with meaning it as ‘Not Avaialble’.
Thanks
M.Ramesh Babu
Associate Director QA
Aizant Drug Research Solutions Pvt Ltd.
As a validation contractor, all the companies I have worked at have used the line through and initial each blank rather than the “not needed” check-box. Several companies that I have worked with have an introductory page in every protocol clearly stating how the protocol should be completed. This ensures that non-company staff (eg contractors) who fill in part of the protocol know how the entries should be completed.
Putting my QA head on - I feel that while it may be more work to complete the protocol, a line through each unused space makes it immediately obvious to a reviewer (QA or an inspector) that the space is NOT required. Every data entry space in a completed protocol should either contain data or be “N/A”'d. There should not be any blank spaces.
Additionally - remember that you MUST NOT introduce the “page not needed” check box to protocols you are writing WITHOUT QA APPROVAL if it has not been previously used. The way a protocol is completed should be stated in a QA/validation SOP so any changes to protocol data entry method will require a change to the SOP (change control and additional staff training will be needed). QA will need a lot of persuading to do that in these days of very tight deadlines!
Yes, so long it is clear to reader (defined) and logical.
A tick checkbox is indeed a good way to kill extra cross/sign/date but inadvertently, it may make it too easy for executor to just check it without going through the whole page detail (I mean whole page of 10-20 fine entries). The crossing of the whole page may alarm the executor if he is very sure that the whole page is not required. Just my suggestion.
Hi all, Just a heads up wrt the tick/check box. As we all know it is really fast and easy to have check boxes. The only issue is that when you have a document that has +2000 check places, for eg a facility IQ document, how sure are you that the tests in question have actually been checked and not mistakenly been checked off due to human error. On the other hand, having to write OK or PASS or DONE for every test is time consuming. The best way to handle this is to have it explained in your GDP SOP. It needs to be carefully explained what, how, when, where and by whom. N/A should be explained, aswell as how to handle corrections in your documents such as E.E is the Acronym for a Entry Error and C.E for Calculation Error. The date format should be fully explained as Europe, Africa and American date standards are different. ie 03 April 2009 or 03/04/09 or 04/03/09. Is the shortened version of a date acceptable, ie 15 Nov. 2008 compared to the full version.
Once it has all been explained in a SOP, nobody can question your reason for performing a certain duty or action in a certain way.