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how thorough should a validation report be?
Posted: Tue Dec 11, 2012 5:39 pm
by darasc0211
Hi, I am generating a validation report and debating on how much details I should include in the report. Is this based on the preference of individual company?
Note: a validation protocol and method will be attached to the report.
In specific, I am debating on the following two items:
1. Should I list all reagents and equipment used during validation or can I just simply refer to the Notebook.
2. Should the detailed preparation be described for each validation parameters? For example, for linearity study, shall I describe details like prepare xx mg/ml stock solution, pipet xxml stock into xx mL VF...or shall I simply state prepare 70%, 90%,100%, 120%, 150% linearity solutions from xxmg/ml stock.
Thanks.
Re: how thorough should a validation report be?
Posted: Tue Dec 11, 2012 8:54 pm
by tom jupille
One way of stating Murphy's Law: "Someone will find a way to misinterpret whatever you specify". Your job is to make that misinterpretation as difficult as possible. More detail is better.
Re: how thorough should a validation report be?
Posted: Wed Dec 12, 2012 10:25 am
by Johnny Rod
Provided you have the details of xx mg in this or that written down somewhere, leave it out of the report. To my mind the report is a summary of the validation with relevant data. Conc vs. peak area for example is relevant, how to arive at that conc in painful detail is not, that's in the method/protocol, which should have already been reviewed and approved. Feel free to put an appendix or two in with some details like the instrument configuration if it is going to be helpful.
Re: how thorough should a validation report be?
Posted: Wed Dec 12, 2012 11:53 am
by Peter Apps
Hi, Is this based on the preference of individual company?
Surely there should be an SOP on how to do validation reports ?
And an SOP for how to write SOPs
Peter
Re: how thorough should a validation report be?
Posted: Wed Dec 12, 2012 2:31 pm
by aceto_81
And an SOP for how to write SOPs
Peter
No kidding: we have that one + a SOP for how to properly read SOPs!
Re: how thorough should a validation report be?
Posted: Wed Dec 12, 2012 8:09 pm
by JGK
As someone who wrote up GLP method validations, reports including data tables and representative chromatography were 40-50 (single-sided) pages.
A reader should be able to take your report and understand what you did. They may not have access to your notebook(s) so unless you include information in the report they may not be able to understand your work.
You don't have to resport spaecifics in the methodology you can report nominal contentration ranges for calibrations etc and get into specifics in the results and discussion.