appropriate理解

beiwei5du

请问大家发表对“appropriate”如何理解？？？？我个人认为的是合规性和操作性。

§211.22   Responsibilities of quality control unit.

(a) There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated. The quality control unit shall be responsible for approving or rejecting drug products manufactured, processed, packed, or held under contract by another company.

(b) Adequate laboratory facilities for the testing and approval (or rejection) of components, drug product containers, closures, packaging materials, in-process materials, and drug products shall be available to the quality control unit.

(c) The quality control unit shall have the responsibility for approving or rejecting all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product.

(d) The responsibilities and procedures applicable to the quality control unit shall be in writing; such written procedures shall be followed.

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下文选自1987 preamble

102. Four comments recommended deletion of 211.22(c) entirely, because either (1) the requirements are adequately covered in 211.22(a), or (2) units of a firm other than the quality control unit have greater expertise in specific areas.     The provisions of paragraph 211.22(a) differ from those of paragraph (c) in that paragraph (a) relates to the actual production of a product, while paragraph (c) covers events which occur before production.  The Commissioner realizes that not all expertise rests with the quality control unit, and he does not believe that the quality control unit should be solely responsible for developing and implementing all procedures and specifications impacting on drug product quality.  A manufacturer may assign primary and initial responsibility for selecting procedures or specifications to the persons or units it believes most qualified. The Commissioner's intent is that the quality control unit be responsible for making sure that the procedures and specifications developed are appropriate and followed.委员会意识到质量管理部门无法掌握所有的专业技术，其也不相信质量管理部门应该是对制定和实施所有影响药品质量的规程和标准的唯一负责部门。生产商可以将规程或标准选择的首要责任指定给其认为更加胜任的人和部门，委员会的目的在于质量管理部门应该对制定的规程和标准的适合性以及是否被遵循负责）。

补充内容 (2017-8-3 18:14):
我主要是想知道关于QA的审核定位方面的啦！

EllenKang

一致就认为是恰当、合适的意思。

一个爱笑的小孩

看到很多ICH 在翻译的时候，都通常翻成“适合的”

villeness

恰当的