Monographs, GMP, EMA, WHO, ICH, PIC/S, ISPE guidelines, DIN/ISO standards etc. pp. and so on. - all have been heard and possibly read and applied; but which guidelines and standards are really legally binding and must be complied with and which are "only" guidelines, but should still be complied with?

Using the example of pharmaceutical water, this presentation aims to shed some light on the regulatory environment and highlight the documents whose content should be known when dealing with pharmaceutical water.