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last update : 2017-10-26
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Elemental impurities according to ICH Q3D

Let us help you for your risk assessment and for the design of control strategies!

On January 1st 2018, all new and existing drug products will have to comply with the ICH Q3D guideline for elemental impurities (EIs).
Although this guideline sets specifications for drug products only, the risk assessment approach also involves the determination of elemental impurities (ex heavy metal impurities) in APIs and excipients.
In this context, Quality Assistance offers consultancy for risk assessment and state-ofthe-art expertise to perform the requested analyses (including two generic ICP/MS methods for the determination of all EIs listed in Q3D).


« Very early (2010), Quality Assistance has detected the high level of concern set by the first drafts of USP chapters <232> and <233> issued in the Pharmacopeial Forum 36 and later by the different steps of Q3D.
For almost 6 years, we've allocated resources to the development and validation of two generic methods which are efficient, rapid and ready-to-use.
Based on our 30 years' experience in analytical services, the finalisation of this project means we are recognised as experts in the field. We are able to provide you with validated and robust methods necessary for risk assesment and design of control strategies ».

Philippe De Raeve - Scientific Director, Quality Assistance

What are the method concept and limitations ? 
What are the ranges of the method ? 
What would be the costs and deadlines involved ?

If you intend to outsource your Q3D implementation, risk assessment and control strategy,  
call this number or send an email to our Business Development team : 

phone +32 (0) 71 53 47 81 (Ask for David Wyngaert) or Email 

They are ready to answer any questions or comments !


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