May be the experts have already indicated the answers, but I am unable to pick the cue from it
. Pl. help me out.
For a FDA audited/approved facility; the question to beat is,
why do we need to get into defining various levels of documents; viz., Quality Policy, Quality Plan etc., especially when these documents are not verified by FDA-Auditors + facility has been approved long without direct influence of them.
(this might be because, ....typically what drives the effectiveness of the quality sysems in pharma facility is about adequacy& compliance of systems/documentation and processes to ensure compliance...ie., "ensuring completeness and correctness of the process/outcome"); of course now a days the emphasis is slowly moving towards CAPA(improvements) and process controls.
I haven't worked directly with ISO systems., but they seem to need certain over-arching documents over and above the CFR 210-211 requirements.
viz., Quality policy(management commitment & Direction), Quality Plan/Manual(measurable objectives) which necessarily seem to provide overview of rest of the processes/SOP implemented.
at a conceptual level, i can interpret that Quality Policy/Plan provide certain amount of direction/commitment of management;
BUT how to answer/convince the value addition of adopting Q10/ISO processes
thanks in advance for your thoughts.