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发帖数: 25265 | 1 【 以下文字转载自 Pharmaceutical 讨论区 】
发信人: skycaptain08 (太尉), 信区: Pharmaceutical
标 题: Re: 请教一个制药过程中金属分析的问题
发信站: BBS 未名空间站 (Tue Oct 14 18:32:56 2014, 美东)
heavy metal is an important quality aspect, however, there is no harmonized
procedure across industry. before it was tested by USP 231, which is just a
color limit test for combined cd pb as hg. with availability of ICP MS ICP
OES, it is highly recommended now to refine this procedure.
however, due to so many existing products on market, this is not gonna
happen overnight. regulatory bodies are making manufactures aware of this
change for a really long grace period before implementation just in case
there is no enough response time.
also, ICH is rolling out heavy metal quality guide under Q3 impurity group
to harmonize this testing requirement and practice. I believe once this ICH
guideline is released, the procedure and requirement will be clear.
ICH Q3d draft on heavy metal:
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3D/Q3D_Step2b.pdf
A presentation: Heavy Metals – USP Perspective
http://www.fda.gov/ohrms/dockets/ac/08/slides/2008-4370s1-10-Guest-Abernethy.ppt.
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