مركز المعرفة
إجابات مرفقة بمصادرها
أسئلة محددة حول مستندات الجودة الصيدلانية، أُجيب عنها بلغة واضحة، يستشهد كل منها بالمصدر الأساسي الذي تستند إليه ويوضح متى كُتبت ومتى روجعت آخر مرة.
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.