e Product summary: Familiarly known as the Orange Guide, this title is an essential reference work for all those involved in the manufacture and distribution of medicines in Europe. It is compiled by the UK drug regulatory body, MHRA, and brings together the European and UK guidance documents ...
In some cultures, it is considered as optional best practice (COULD do) and in others as "word for word" mandatory (MUST do). The guidance needs to be worded so that it best fit this wide spectrum of interpretation.Kay O'HaganEuropean journal of parenteral & pharmaceutical sciences: the ...