A strategy for excellence

       

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 metallic impurities in APIs and excipients.

In this context, Quality Assistance offers consultancy for risk assessment and state-of-the-art expertise to perform the requested analyses. 

Quality Assistance offers you a complete dedicated service: 

  • 2 generic ICP/MS methods for the determination of all EIs listed in Q3D
  • cGMP certified environment
  • 5 ICP-MS
  • 2 microwave digestion systems
  • 5 highly skilled analysts
  • Expert advice for risk assessment and control strategy design

Our experts provide you with a scientific and technical support to help you: 

  • to design an appropriate risk assessment strategy
  • to establish your control strategy and justify wether systematic analytical testing will be required to assess the safety of drug product batches
  • to carry out the necessary analytical determinations and validations ! 

philippe-deraeve-webinar-elemental-impurities-quality-assistance                           

Conference : Elemental Impurities according to ICH Q3D:  
APIs & excipients as potential sources. Oct 2015

 

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 implementationrisk 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 david.wyngaert@quality-assistance.be 

They are ready to answer any questions or comments !

 

 
« 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

 
 
 
 
 
Resources
Press release - Communiqué de presse

Elemental Impurities : The pharmaceutical industry is up against the wall!

access-webinar-quality-assistance

 

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