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附带来源出处的解答
针对药品质量文件的具体问题，以通俗语言作答，每篇均引用其所依据的主要来源，并注明撰写与最近一次审阅的时间。
What must a certificate of analysis for an API contain?
The elements ICH Q7 expects on a certificate of analysis for an active pharmaceutical ingredient: identity of the material and batch, the dates, every test with its limit and result, and a dated signature from the quality unit with the manufacturer's details.
Retest date or expiry date: what is the difference, and what should a COA show?
The two dates mean different things. An expiry date is the point after which a material should not be used; a retest date is the point at which it should be re-examined. ICH Q7 defines both and says which should appear on a certificate of analysis.
Can a manufacturer rely on a supplier's certificate of analysis instead of testing?
Partly, and only under conditions. US, EU and ICH requirements all allow a supplier's certificate to replace some in-house testing, but each insists on an identity test of every batch, on establishing the reliability of the supplier's results, and on confirming them at intervals.