Elemental impurities: how to be compliant with ICH Q3D guideline?

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.

Access the slides of this webinar which presented how the Q3D guideline for EIs can be efficiently implemented for all drug substances, excipients and drug products.

On 1st June 2016, all new drug products will have to comply with the ICH Q3D guideline for elemental impurities (EIs) and on 1st January 2018, all existing products will also have to fulfill the same requirements. Although this guideline sets specifications for drug products only, the risk assessment approach also involves the determination of metallic impurities in APIs and excipients.

Considering the huge number of samples which will have to be tested, Quality Assistance has developed and validated a generic cost effective ICP/MS procedure for the determination of the EIs listed in Q3D.
Our staff of experts is ready to help you to design an appropriate risk-based strategy and to carry out the necessary analytical determinations with our dedicated instruments (5 ICP-MS).

15^th Oct 2015

What implications for APIs & excipients suppliers?

ICH Q3D Step4 will have to be applied very soon: June 2016 for new Drug Products and
1st January 2018 for all existing DP, making it mandatory for all manufacturers to carry out a risk assessment to control elemental impurities in their DP.

Such evaluation needs to consider all potential sources of Elemental Impurities and obviously, drug product components are probably the most likely contributors.

Access the slides of this 30 minute webinar to learn how the Q3D guideline for EIs can be efficiently implemented for all drug substances, excipients and drug products. 

Drug product manufacturers will soon require Elemental Impurities (EIs) specifications and/or batch analysis for all APIs and Excipients! 

Quality Assistance has developed a unique analytical strategy to reduce the costs linked to these regulation changes. Our concept consists of quantifying all elemental impurities using a fast, cost-effective generic ICP-MS method. Using our methodology will:

• save your customers a lot of time for their risk assessment
• avoid any specific method development to quantify elemental impurities

Such an analytical assessment will very soon become a market requirement and will therefore be a key selling point for you!