Consumer Products Guy wrote:
I've been fortunate.
I have a BS Chemistry and I work in a lab that's pretty well-equipped. I've half-dozen publications, done a ton of method development work including quite a few cGMP method validations and GLP method validations, and seem to have a knack to develop test methods simple enough for QC use/sample preparations.
The last decade has been challenging, as now we have to have SOPs for stuff like our glassware dishwasher, how we know that a standard is a standard, etc. Dealing with most stuff from the USP is a nightmare, like can one use 0.5N titrant instead of 1N? Sure, if one can show equivalency; so what determines equivalency? USP doesn't say, just says needs to be equivalent, so very frustrating.
So I'd say this is the toughest part. I read on this site how people have trouble with USP assay procedures, yet apparently most just use them as determining equivalency or validating a modification brings up a whole new set of issues. Sad. I "like" stuff like the benzethonium chloride monorgraph where the assay takes 10 minutes, but standardizing the titrant (made from 99.5+% pure stuff) takes practically all day to standardize, and a gravimetric procedure in singleton yet, where the precipitate sticks to glass. Have fun with that one!
I have dabbled a little in the USP work, mostly HPLC methods, and it is frustrating that everything is based on such old ways of doing things. One method wanted something like 3 minutes separation between two analytes or else the method failed, which completely precludes using UPLC or even narrow bore columns.
I think though that EPA/NELAC work is even worse. Even if a method has what is clearly a typo, you have to argue for weeks with an auditor that you are actually doing it correctly. We once had a state regulation that called for the analysis of 1,2-Dibromomethane. It took forever to explain to the auditor why the compound was not in my standard
I used to report it on my state forms flagged as DNE.