Conventional terms
Conventional terms
The term "competent authority" means the national, supranational or international body or organisation vested with the authority for making decisions concerning the issue in question. It may, for example, be a national pharmacopoeia authority, a licensing authority or an official control laboratory.
The expression "unless otherwise justified and authorised" means that the requirements have to be met, unless the competent authority authorises a modification or an exemption where justified in a particular case.
Statements containing the word "should" are informative or advisory.
In certain monographs or other texts, the terms "suitable" and "appropriate" are used to describe a reagent, micro-organism, test method, etc.; if criteria for suitability are not described in the monograph, suitability is demonstrated to the satisfaction of the competent authority.
0 条评论:
发表评论
订阅 博文评论 [Atom]
<< 主页