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JPAG - Articles and news items

Dave Elder, Joint Pharmaceutical Analysis Group and GSK

ICH M7 Mutagenic impurities: A critical evaluation

Issue 1 2014 / 19 February 2014 / Dave Elder, GlaxoSmithKline and JPAG

Whereas the existing ICH quality documents covering impurities in new drug substances (ICH Q3A(R2)) and drug products (ICH Q3B (R2)) provide a framework for the qualification and control of most commonly encountered impurities and degradants, it is recognised that lower thresholds may be appropriate if the impurity is unusually toxic (e.g. DNA reactive). The emerging ICH M7 guidance seeks to provide a practical basis for the identification, characterisation, qualification and control of mutagenic impurities. Its role in the pantheon of guidance is therefore to supplement and complement the existing guidance enshrined in ICH M3(R2), ICH Q3A(R2), ICH Q3B(R2) and probably the emerging ICH Q3D document…

David Elder

ICH Q3D: Metal Impurities: A Critical Evaluation

Issue 5 2013, PAT & QbD / 22 October 2013 / David Elder, JPAG and GlaxoSmithKline / Andrew Teasdale, JPAG chairman and AstraZeneca

Historically, control over metal impurities has been achieved via pharmacopoeial heavy metals limit tests, e.g. United States Pharmacopeia (USP) <231>. These tests involve the formation of a metal sulphide precipitate, but such methods are non-specific and inaccurate for many elements. As a consequence, there has been a concerted drive by industry, pharmacopoeias and regulators to develop more effective approaches to the analysis and control of elemental impurities, leading to a number of international guidelines…

 

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