forgive me for being broad&cryptic in representation of key areas; but the idea is to emphasize the
1) key-repeated-gaps being "identifying&reporting incidents - qualifications & validations (both material - equipment - process) - investigations(RCA & CAPA)
2) most observations are(at least 60:40) are about having system not adequately&complete following (there are fewer things about not having system itself...i guess)
BTW,
Would it be correct to say that, warning letters signify the firms inability to comprehensively & timely address the observations; hence 483s are more of reflective of agencies priorities & focus?
corollary to that point is ...
well it looks like, what can be inferred from 483s/warning letters is that; more than 50% of cases are to do with the ""lack of application/execution/compliance"" of SOPs; but 90% of industry seems to be running towards having a SOP in place;
on contrary, all the discussions are running towards the having a flawless/comprehensive SOP;
surprising thing is that very few discussions on making the things complete.(complete - comprehensive discussions on application-implementation-execution of various problems)
what I am trying to say here is that;
if you take common problems outlined such as investigations (RCA - CAPA), how many discussion do we see discussing the problem of water system product-OOS/NCs; (vs discussion on SOP for water system validation which is very generic level)
its time to start discussing (atleast at generic level) the specific problems and approach to investigations;
there ought to be general templates (viz, fish bone diagrams, failure modes) etc., available for most of unit operations.
but we seldom see them in open domain.
instead of laying emphasis on finding lasting solutions (non-repeating action); another area where emphasis is misplaced is that 'control' endowed in the name of "documentation" or "QA function".(this is true atleast for pharma);
apart from other reasons, that is probably one reason why pharma is left behind in the race of quality-concepts and tools.
hope to hear your thoughts.